2024 Recap: Medical Device key Regulation/Guidance in USA, EU, Asia and ROW

• USA
• EUROPE
• AUSTRALIA
• BRAZIL
• CANADA
• CHINA
• COLUMBIA
• CZECH-REPUBLIC
• FINLAND
• FRANCE
• GERMANY
• HONG-KONG
• HUNGARY
• ICELAND
• INDIA
• IRELAND
• ITALY
• JAPAN
• LATVIA
• LITHUANIA
• MALAYSIA
• MEXICO
• PHILIPPINE
• PORTUGAL
• SAUDI ARABIA
• SINGAPORE
• SLOVAKIA
• SOUTH KOREA
• SPAIN
• SRILANKA
• SWITZERLAND
• THAILAND
• UNITED KINGDOM

USA

Guidance on Global Unique Device Identification Database (GUDID)

The guidance announces updates to the Global Medical Device Nomenclature (GMDN) field in GUDID, including the removal of FDA Preferred Term (PT) Codes, as access to GMDN Terms has been free since April 2019. GUDID users are now required to use GMDN codes per 21 CFR 830.310(b) (13). Database improvements for user experience, validation, and other changes are ongoing, with periodic updates to reflect system enhancements.

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile

This guidance document updates and clarifies the information regarding sterilization processes that we recommend sponsors include in 510(k)s for devices labeled as sterile. FDA considers there to be two categories of sterilization methods currently used to sterilize medical devices in manufacturing settings: established and novel. These processes are defined in this guidance document, and examples are provided for each category.

Accreditation Scheme for Conformity Assessment (ASCA)

The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality.

The FDA is implementing ASCA in accordance with:

• Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the Food and Drug Omnibus Reform Act of 2022, and
• The Medical Device User Fee Amendments of 2022 (MDUFA V).

If we would like to receive notifications about ASCA, email ASCA@fda.hhs.gov.

U.S. Food and Drug Administration (FDA) issued Update on Artificial Intelligence and Machine Learning in Software as a Medical Device

The paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle.

CBER, CDER, CDRH and OCP plan to tailor their regulatory approaches for the use of AI in medical products to protect patients and health care workers and ensure the cybersecurity of medical products in a manner that promotes innovation.

Remanufacturing of Medical Devices- Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff

The guidance is intended to help clarify whether activities performed on devices are likely “remanufacturing.” Such clarification is intended to help provide consistency and better understanding of applicable statutory and regulatory requirements. The guidance also includes recommendations for information that should be included in labeling to help assure the continued quality, safety, and effectiveness of devices that are intended to be serviced over their useful life. In developing this guidance, FDA considered objective evidence and information learned from the Agency’s activities discussed in this guidance.

Guidance on Laboratory Developed Tests: Small Entity Compliance Guide

FDA published a final rule in the Federal Register entitled “Medical Devices; Laboratory Developed Tests” (89 FR 37286) (“LDT Final Rule”). The final rule amends FDA regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. FDA has prepared the Small Entity Compliance Guide to assist small entities in complying with the requirements established in FDA regulations as they apply to IVDs, including LDTs.

Guidance on Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection

The guidance covers facilities that are subject to drug or device inspection under section 704 of the FD&C Act.  The guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of section 501(j) of the FD&C Act.

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers

The VMSR (Voluntary Malfunction Summary Reporting) Program allows device manufacturers to report certain device malfunctions quarterly in summary form instead of submitting individual malfunction reports. Manufacturers can voluntarily participate without needing FDA approval and may opt out at any time. If they leave, they must resume individual malfunction reporting within 30 days and update their procedures accordingly. The program helps the FDA monitor device safety and effectiveness more efficiently by ensuring sufficient information is provided to detect safety issues and trends. Eligibility criteria and reporting conditions are detailed in the guidance.

Small Entity Compliance Guide on Mammography Quality Standards Act and Regulation Amendments

Mammography is an x-ray exam used to detect breast cancer, and its effectiveness depends on high-quality services, including qualified technologists, well-maintained equipment, and accurate interpretation by physicians. The Mammography Quality Standards Act (MQSA) sets federal standards to ensure all patients have access to quality mammography. These standards cover accreditation, personnel qualifications, equipment, quality assurance, and communication of results. The 2023 MQSA Rule updates these regulations, requiring mammography reports to include breast density information, with clear summaries provided to patients and their healthcare providers. FDA guidance documents offer recommendations but are not legally binding unless specified.

Guidance on Electronic Submission Template for Medical Device De Novo Requests

The guidance outlines the technical standards for preparing the electronic submission template for De Novo classification requests, allowing submissions to be made entirely in electronic format. The template is designed to help collect and organize all necessary elements for a complete submission. While the guidance does not define the user interface or specific content of the eSTAR tool, it sets the electronic format and standards for compliance with section 745(A)(b)(3) of the FD&C Act. FDA plans to update eSTAR as policies evolve and continues to gather public comments and feedback through its website.

FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act

The guidance outlines the procedures for submitting, reviewing, and responding to requests for information about a device’s classification or the applicable requirements under the FD&C Act, in accordance with section 513(g) of the Act. FDA guidance documents provide the Agency’s current thinking and recommendations on a topic but are not legally binding unless specific regulatory requirements are mentioned. The term “should” in these guidance indicates a suggestion or recommendation, not a mandate.

Guidance on Acceptable Media for Electronic Product User Manuals

The guidance clarifies that manufacturers may provide user manuals for electronic products in either paper or electronic formats. This change acknowledges the increasing reliance on electronic media, which reduces paper usage, improves accessibility, and enables rapid updates. FDA guidance documents reflect the Agency’s current views and offer recommendations, but they are not legally binding unless specific regulations are cited. The term “should” in these guidances suggests a recommendation, not a requirement.

Air Powered Dental Handpieces and Air Motors – Performance Criteria for Safety and Performance Based Pathway

The devices covered by this guidance include dental air-powered handpieces, air motors (product code EFB), and contra- or right-angle attachments (product code EGS). These are classified as Class I (reserved) devices under 21 CFR 872.4200. The guidance applies to devices with a primary structure made from materials such as stainless steel or titanium, with a maximum rotational speed of 450,000 revolutions per minute (RPM), and are designed to be sterilized by the end user.

The dental handpieces referenced in this guidance are intended for use in general dentistry procedures, such as cutting and grinding teeth, cavity preparation, tooth and crown preparation, and the finishing and trimming of teeth and filling materials.

Guidance on Dental Cements – Performance Criteria for Safety and Performance Based Pathway

The guidance provides performance criteria for dental cements under the FDA’s Safety and Performance Based Pathway. Manufacturers submitting a 510(k) for dental cements can use these criteria to demonstrate substantial equivalence, instead of directly comparing their device to a predicate device. For relevant standards, manufacturers can refer to the FDA Recognized Consensus Standards Database and are advised to include supporting documentation if submitting a Declaration of Conformity to a recognized standard. The guidance is being implemented without prior public comment as the FDA considers it a less burdensome and public health-consistent policy.

Guidance on Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment

The guidance explains that diagnostic x-ray systems are both medical devices and electronic products under the FD&C Act, subject to provisions for both categories. It consists of two sections: one covering general information on diagnostic x-ray equipment and the other addressing specific performance standards in 21 CFR 1020.30-1020.33. The guidance focuses only on the electronic product radiation control (EPRC) provisions, not medical device regulations. To streamline regulatory reviews, the FDA aims to align its standards with international IEC standards. Manufacturers are encouraged to review related FDA guidance and stay informed on updates regarding radiation-emitting products.

Guidance on Conducting Clinical Trials with Decentralized Elements

The guidance provides recommendations for sponsors, investigators, and other stakeholders on implementing decentralized elements in clinical trials, where trial-related activities occur remotely at locations convenient for participants. Decentralized elements can include telehealth visits, in-home visits, or visits with local healthcare providers. The FDA’s regulatory requirements for medical product investigations apply equally to trials with or without decentralized elements.

The guidance fulfills section 3606(a) of the Consolidated Appropriations Act, 2023, which directs the FDA to issue recommendations to clarify and promote the use of decentralized clinical trials (DCTs) in drug and device development. It also references the 2023 guidance on digital health technologies for remote data collection in clinical investigations.

Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders

This guidance outlines the processes available for mammography facilities to request a review of adverse decisions related to accreditation, certificate suspension or revocation, and patient and referring provider notification (PPN) orders.

If a facility disagrees with an accreditation body’s decision, it can appeal to the accreditation body and, if unresolved, request further review by the Director of FDA’s Division of Mammography Quality Standards (DMQS). A formal hearing with the Departmental Appeals Board can be requested if the facility is dissatisfied with the FDA’s decision.

Facilities challenging a suspension or revocation of an FDA-issued certificate may request an informal hearing. If the certificate was issued by a State Certification Agency (SAC), the facility should appeal to the respective SAC. Appeals of PPN orders can be submitted for supervisory review under 21 CFR 10.75.

Guidance on Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development

The guidance provides a framework for determining whether, and what type of, long-term neurologic, sensory, and developmental evaluations may be useful to assess the safety of a “medical product” (such as a drug, biological product, or device) for use in neonates. Additionally, it helps identify which neurodevelopmental domains are most relevant for evaluating safety in this population.

Guidance on Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway

The guidance establishes performance criteria for root-form endosseous dental implants and abutments under the Safety and Performance Based Pathway, allowing 510(k) submitters to demonstrate substantial equivalence using these criteria instead of direct comparison to predicate devices. Submitters should refer to the FDA Recognized Consensus Standards Database for relevant standards and include supporting documentation if declaring conformity to a recognized standard. Implemented without prior public comment under section 701(h)(1)(C)(i) of the FD&C Act, this guidance is intended as a less burdensome approach aligned with public health goals and is open to comments per FDA’s good guidance practices. It applies to Class II devices regulated under 21 CFR 872.3640 (product code DZE) and 21 CFR 872.3630 (product code NHA).

Guidance on Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices

The guidance outlines the principles and information required for FDA consideration of enforcement discretion regarding sterilization site changes for PMA and HDE holders of Class III single-use devices sterilized with ethylene oxide (EtO). It provides recommendations for voluntary informal notifications to FDA when transitioning to alternative sterilization facilities to mitigate disruptions caused by operational changes at approved EtO facilities.

Guidance on Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions

The guidance outlines recommendations for premarket notification (510(k)) submissions for Class II, non-resorbable orthopedic bone plates, screws, and washers used in bone fixation, excluding spinal, mandibular, maxillofacial, cranial, and orbital applications. It applies to devices made from specific materials like titanium alloys, stainless steel, cobalt-chrome alloys, PEEK, and carbon-fiber-reinforced PEEK, following ASTM standards.

Exclusions:

The guidance does not address devices with characteristics such as nitinol materials, coatings, surface modifications, antimicrobial agents, unique geometries, modular designs, unconventional techniques, resorbable materials, or additive manufacturing. It also excludes devices for mandibular, maxillofacial, cranial, orbital, or spinal use, suture anchors, and bone anchor tightrope systems.

Manufacturers of excluded devices are advised to seek FDA feedback via the Q-Submission Program for guidance on their specific cases.

Guidance on 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

The 510(k) Third Party (3P510k) Review Program, authorized under section 523 of the FD&C Act, allows FDA-recognized third parties to review certain low-to-moderate risk medical device 510(k) submissions and recommend initial device classifications. This program, implemented by the Center for Devices and Radiological Health (CDRH), supports efficient regulatory review processes.

Additionally, FDA may contract third-party organizations for Emergency Use Authorization (3PEUA) reviews during active emergency declarations under section 564 of the FD&C Act.

Guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions

The FDA is committed to advancing innovative regulatory approaches for medical device software, particularly those incorporating artificial intelligence (AI) and machine learning (ML), to ensure safety and effectiveness. AI-enabled medical devices have the potential to revolutionize healthcare by providing earlier diagnoses, personalized treatments, and enhanced user and patient experiences.

Recognizing that AI device software functions (AI-DSFs) undergo iterative improvements, the FDA’s guidance outlines a framework to facilitate these updates with minimal regulatory burden while maintaining safety and effectiveness. A key element is the Predetermined Change Control Plan (PCCP), which manufacturers should include in their marketing submissions. The FDA will review PCCPs during marketing submissions to allow approved updates without requiring new submissions for each modification.

EU

Verification of manufactured class D IVDs by notified bodies

The document provides guidance for notified bodies on their roles and responsibilities concerning samples or batches of manufactured class D IVDs under Annexes IX and XI of the IVDR. It outlines best practices for conformity assessments, including:

Information to include in notified body procedures,

Content of pre-agreed conditions and arrangements with manufacturers, and

Guidance on the frequency of device or batch sample submissions to the EURL.

The guidance and IVDR batch testing requirements apply only to devices where the concept of batches is relevant, excluding class D medical device software.

EMA updates SME guide to reflect clinical trial reporting requirements

The European Medicines Agency (EMA) has updated its user guide for small and medium enterprises (SME) based on new requirements coming into effect under the EU Medical Devices Regulation (MDR). It touches on issues such as clinical trial requirements, use of the agency’s IT systems, addresses products with regulatory framework uncertainty, and more.

The guide is specifically catered to SMEs that may not have the resources of larger companies to specialize in EMA regulations and emphasizes requirements that are specific to their needs.
 The biggest update to the document addresses clinical trial regulations and the agency’s Clinical Trials Information System (CTIS). EMA notes that previously, sponsors were required to submit clinical trial information separately to countries in the EU or European Economic Area (EEA), but now they can transition to the CTIS, where individual countries can retrieve the information, which will be phased in over the next few years.
 EMA said it foresees a three-year transition period to implement CTIS requirements under the 2014 Clinical Trials Regulation. The agency has already required sponsors to submit initial clinical trial applications, starting last year.

Commission proposes to extend transition periods for certain IVDs, gradual roll-out of Eudamed and an information obligation in case of interruption of supply

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety.

Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices and are proposing to take additional steps:

• To ensure the availability of in vitro diagnostics by allowing more time for manufacturers to transition to the new rules, subject to certain important conditions.
• To enhance transparency and protect patient care by speeding up the launch of some parts of the European Database on Medical Devices – EUDAMED
• To provide healthcare systems with more time to safeguard patient care by obliging manufacturers to notify in case of disruption of supply of certain medical devices and in vitro

MDCG 2024-1 – Device Specific Vigilance Guidance (DSVG) Template

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices.

It provides further clarification for vigilance reporting of Specific Devices to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) [1] and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) [2]. This DSVG does not replace or extend any of those requirements.

The document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR and in Article 2(67) and (68) IVDR, in accordance with Articles 87 and 88 MDR and Articles 82 and 83 IVDR, which occurred with Specific Devices to the relevant Competent Authority.

MDCG 2024-2 – Procedures for the updates of the European Medical Device Nomenclature

The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 – In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users

The document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.

• Actors involved
• Procedure for the annual revision of the EMDN
• Pilot procedure for the ad-hoc updates of the EMDN requiring an expedited review

Commission tracks 35% increase in MDR applications, reduction in missing documents

The number of applications for certification under the Medical Device Regulation (MDR) increased 35% between June and October according to survey data collected by the European Commission.

The Commission also presented data on the In Vitro Diagnostic Regulation (IVDR). The number of IVDR applications and certificates rose 30% and 40%, respectively, from June to October. The number of filings and certificates for Class D devices, the products with the near-term deadline that informed plans to extend the timeline, hit 336 and 119, respectively, in October.

Overview of language requirements for manufacturers of medical devices

Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The table gives an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers. Member States are not obliged to determine a specific language. Having regard to the costs related to providing information in various languages, Member States are encouraged to consider whether information to be provided by the manufacturer could be accepted in another language than their national language (e.g. in English) if the safe use of the device is not compromised, especially regarding devices for professional use.

EPA finalizes rule to reduce EtO emissions from sterilization

EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. Since 2019, EPA has been gathering information about how to reduce people’s risk from exposure to ethylene oxide (EtO). This rule is one of the most important measures EPA is taking to reduce emissions of EtO while mitigating and managing any potential supply chain impacts. The Clean Air Act standards EPA is finalizing will reduce lifetime cancer risks associated with EtO emissions from commercial sterilizers down to or below the benchmark of 100 cancer cases per million people exposed. And the number of people with a potential risk of greater than or equal to one in one million will be reduced by approximately 92 percent.

European Commission adopts harmonized standards for medical device sterilization

The European Commission has adopted implementing decisions on harmonized standards for sterilized medical devices.

Under the EU medical device and in vitro diagnostic (IVDs) regulations, products that conform to harmonized standards are presumed to meet the relevant regulatory requirements. The Commission asked other EU bodies to draft new harmonized standards to support the regulations, resulting in documents about the sterilization of a range of medical devices and diagnostics.

Officials have ruled that the proposed standards satisfy the requirements, leading the Commission to create two implementing decisions. One decision adds three standards related to sterilization to an annex of an existing document about IVDs. The other document adds the sterilization standards, plus other texts about medical gloves and more, to the annex of an existing decision on medical devices.

MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR.

According to section 2 of Chapter I of Annex XV of the MDR, clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge, and defined in such a way to be able confirm or refute the manufacturer’s claims regarding the safety, performance and aspects relating to the benefit-risk determination of devices. The clinical investigation shall include an adequate number of observations to guarantee the scientific value and validity of the conclusions. The procedures and research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation.

MDCG 2024-5 – guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

The IB shall contain the clinical and non-clinical information on the investigational device that is relevant for the investigation and available at the time of application. The information shall be presented in a concise, simple, objective, balanced, and non-promotional form that enables a potential investigator and the investigation site team, to understand it and make his/her own unbiased benefit-risk analysis of the appropriateness of exposing study participants to the investigational device. Further the IB should contain sufficient information to allow safe and correct use of the device.

The document is intended to support sponsors in developing their IB by describing in greater detail what type of information is expected in the respective IB sections, in order to preempt questions from the competent authorities during the assessment of the clinical investigation application. The guidance is based on the requirements of both the MDR and ISO14155:2020 as well as experience from the competent authorities.

MDCG 2022-9 / Rev.1 – Summary of safety and performance

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR) requires that the manufacturer shall draw up a summary of safety and performance (SSP) for class C and D devices, other than devices for performance studies. The SSP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed).

The SSP should include information dedicated to the intended user, and if relevant, the patient. The SSP shall be kept updated in Eudamed. If the device is not intended for self-testing, the SSP should be dedicated to the professional user. If the device is intended for self-testing, the SSP should be written in a way that is clear to the patients/lay persons, for instance taking into consideration the age of the targeted population.

MDCG 2024-4 – Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

Safety reporting in performance studies of in vitro diagnostic medical devices (IVDs) shall be performed in line with the requirements of Article 76(2) of Regulation (EU) 2017/746 – In Vitro Diagnostic Medical Device Regulation (IVDR). The sponsor shall report without delay to all Member States in which a performance study is being conducted all of the following by means of the electronic system referred to in IVDR Article 69

For post-market performance follow-up (PMPF) studies of CE marked devices1 used within the intended purpose covered by the CE marking, reporting requirements of IVDR Articles 76(5-6) apply. This means that the vigilance provisions laid down in IVDR Articles 82 to 85 and in the acts adopted pursuant to IVDR Article 86 apply to PMPF studies.

A Study and dashboard on reprocessing and reuse of single-use-devices in the EU

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) – through the European Health and Digital Executive Agency (HaDEA) – commissioned a “Study on the implementation of Article 17 of Regulation (EU) 2017/745 on medical devices on the EU market

The study started in December 2022 and was performed over 14 months. It was contracted to a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG), in collaboration with Civic Consulting, S&P Global and Areté). The study main objective is to evaluate how the provisions established in the MDR have been implemented in European countries and how such provisions operate.

MDCG 2022-4 Rev 2: Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

Appropriate surveillance only applies to legacy devices that are covered by a certificate issued in accordance with the MDD or AIMDD. Legacy devices for which the conformity assessment procedure pursuant to the MDD did not require the involvement of a notified body, but that require the involvement of a notified body under the MDR are not subject to appropriate surveillance under Article 120 MDR.

The guidance document outlines the activities to be performed by notified bodies as part of the appropriate surveillance defined in Article 120(3e) MDR. In order to clarify elements to be verified by notified bodies, this guidance document also covers requirements concerning certain manufacturers’ obligations, especially in respect to their quality management system.

MDCG published New guidance on the clinical evaluation of orphan medical devices

The guidance outlines criteria for determining when a medical device or its accessory qualifies as an “orphan device” under the Medical Devices Regulation 2017/745 (MDR). It aims to assist manufacturers and notified bodies in meeting the MDR’s clinical evidence requirements and addresses challenges that delay patient access to orphan devices. The guidance also allows manufacturers and notified bodies to seek advice from European Medicines Agency expert panels on orphan device status and necessary clinical data for evaluation.

MDCG 2024-1-5: Guidance on the vigilance system for CE-marked devices – Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence

The Device Specific Vigilance Guidance (DSVG) aims to harmonize vigilance reporting for manufacturers of Urogynaecological Surgical Mesh Implants used in Pelvic Organ Prolapse repair and Stress Urinary Incontinence. The document provides clarification on reporting incidents and serious incidents to the relevant Competent Authority, in accordance with Regulation (EU) 2017/745 on medical devices (MDR).

Update – MDCG 2021-5 Rev.1 – Guidance on standardization for medical devices

The document aims to provide guidance on various aspects related to standards in the medical devices sector, supporting the requirements outlined in the applicable EU legislation, while considering its specificities.

European Commission proposes common specifications for IVDs for parasites, viruses

The European Commission has proposed updates to common specifications for certain class D in vitro diagnostic devices to include tests for specific parasites and viruses of public health concern. Stakeholders have four weeks to comment on these proposed amendments, which, if finalized, will revise Regulation (EU) 2017/746 to address additional public health issues.

Application of transitional provisions for certification of class D in vitro diagnostic medical devices under Reg (EU) 2017/746

The document outlines the process under Regulation (EU) 2017/746 (IVDR) for conformity assessments of Class D in vitro diagnostic medical devices (IVDs). Manufacturers must submit applications to a notified body, and certain aspects of the assessment may involve review by an expert panel and/or testing by an EU Reference Laboratory (EURL). The document provides guidance on applying IVDR provisions related to expert panels and EURLs before the IVDR’s enforcement date (26 May 2022) and leading up to the activation of EURL tasks starting on 1 October 2024, as per Commission Implementing Regulation (EU) 2023/2713.

Guidance on the validity of clinical studies for joint clinical assessments

The European Commission has published guidance on the validity of studies for joint clinical assessments (JCA) under the EU Health Technology Assessment Regulation (HTAR). The guidance emphasizes assessing and describing the certainty of study results in an objective, reproducible, and transparent manner as part of the HTA process. JCAs evaluate the certainty of relative effects based on the strengths and limitations of evidence, but without value judgments, as mandated by HTAR.

The guidance clarifies that appraisal methods that include value judgments, such as those influencing pricing or reimbursement, are not applicable at the European HTA level. However, valid scientific principles are essential for developing JCAs that are clear and interpretable at the national level.

Q&A In Case of Interruption or Discontinuation of Supply Of Certain Medical Devices and in Vitro Diagnostic Medical Devices

The Q&A document addresses practical aspects related to the implementation of the Article 10a obligation concerning interruptions or discontinuations of supply for certain medical devices, as introduced by Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 and (EU) 2017/746. It covers three main areas: the gradual roll-out of Eudamed systems to enhance device registration and monitoring, the obligation for manufacturers to notify relevant authorities and health institutions in the event of supply disruptions, and the transitional provisions for specific in vitro diagnostic medical devices. The guidance aims to assist stakeholders in navigating these requirements effectively to ensure compliance and continuity in device supply.

Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

The document explains the important differences between Regulation (EU) 2017/745 on medical devices (MDR) and Directive 2001/83/EC on medicinal products for human use (MPD). Understanding these differences is key to properly applying and enforcing these laws. The document clarifies several rules in both the MDR and MPD to help ensure the MDR is applied consistently across the EU.

The document starts with a general overview of the differences between medical devices and medicinal products, including definitions and examples. It also includes specific sections on herbal products, substance-based devices, and combinations of medical devices and medicinal products.

Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC

Regulation (EU) 2023/607 has amended the transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR). In particular, the transitional period has been extended from May 26, 2024, to December 31, 2027, or December 31, 2028, depending on the device’s risk class and certain conditions. The document offers updated guidance on how MDR requirements apply to “legacy devices” and “old” devices, reflecting the recent amendments to the MDR transitional provisions. Additionally, the annex includes a non-exhaustive table that outlines which MDR requirements are applicable or not applicable to these “legacy devices.”

Guidance on qualification of in vitro diagnostic medical devices

The guidance document clarifies which products fall under Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) and outlines the criteria for classification as an IVD or an accessory. To qualify, products must align with the definitions in Articles 2(2) or 2(4) of the IVDR, based on the manufacturer’s intended purpose. It is important to note that the IVDR is distinct from Regulation (EU) 2017/745 on medical devices (MDR), which does not cover IVDs. The document provides examples of IVDs and their accessories, with more detailed examples in the Manual on Borderline and Classification. Manufacturers must assess each product individually, as qualification may differ based on intended use.

Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

The guidance document is for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved with Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). It should be read along with MDCG 2022-13, which explains how CABs and NBs are designated and reassessed, and it provides templates to use during assessments. While using these templates isn’t required, they can make the review process for corrective and preventive actions (CAPA) easier.

The document explains how NBs should create CAPA plans for addressing non-compliances (NCs), how DAs should review these plans, and how JATs should evaluate them along with the DAs’ opinions. It highlights the importance of accurately repeating the wording and classifications of NCs in the CAPA template. Clear communication throughout the CAPA process is crucial for timely and effective reviews by JATs.

Guidance on the implementation of the Master UDI-DI solution for contact lenses

The Unique Device Identification (UDI) system, as outlined in Article 27 of Regulation (EU) 2017/745 (MDR), ensures the identification and traceability of medical devices. Manufacturers are required to assign Basic UDI-DIs, UDI-DIs, and UDI-PIs to all devices, excluding custom-made ones, before market placement. These identifiers must be registered in the European Database on Medical Devices (Eudamed) to enhance traceability.

For highly individualized devices like contact lenses, the regulation introduces the concept of a Master UDI-DI under Annex VI, Part C, Section 6.6.1 MDR, as amended by Commission Delegated Regulation (EU) 2023/2197. While all economic operators contribute to traceability, manufacturers bear the primary responsibility for device identification and traceability.

The guidance document outlines the rules for implementing Master UDI-DI for contact lenses, covering its structure, assignment, labelling, and registration in Eudamed.

Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860

The document provides a Q&A overview regarding the implementation of the gradual roll-out of Eudamed, as outlined in Regulation (EU) 2024/1860, which amends Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). It addresses the following key areas:

Extended Conformity Assessment for IVDs: Additional time is granted for IVD conformity assessments under the IVDR to ensure patient safety and prevent shortages without compromising quality.

Supply Interruption Notifications: Manufacturers must notify authorities and health institutions of supply interruptions or discontinuations, with intermediaries responsible for informing relevant stakeholders in indirect supply chains.

Gradual Roll-Out of Eudamed: Phased implementation of Eudamed’s systems allows early use of finalized modules, enhancing transparency, monitoring, and access to device information.

A Q&A document details the gradual roll-out of Eudamed.

Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746

The document clarifies key terms and concepts outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). A shared understanding of these terms is essential for the effective and harmonized implementation of vigilance requirements under these regulations.

It targets competent authorities, economic operators, and stakeholders, adapting definitions from the Guidelines on a Medical Devices Vigilance System to align with MDR and IVDR. The term devices include medical devices, their accessories, Annex XVI MDR products, and in vitro diagnostic devices. References to the Regulations cover both MDR and IVDR.

MDCG 2024-16: Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices

The form is to be utilized by manufacturers, their authorized representatives, or any other parties acting on behalf of the manufacturer to notify Competent Authorities of any interruption or discontinuation in the supply of certain medical devices and in vitro diagnostic medical devices, as outlined in Article 10a of the MDR/IVDR.

MDCG 2024-15 – Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED

Under Article 77(5) MDR, sponsors must submit a clinical investigation report and a user-friendly summary via EUDAMED within one year after the investigation ends or three months in cases of early termination or temporary halt. Article 77(7) MDR mandates that these documents become publicly accessible through EUDAMED when the device is registered under Article 29 and before market placement, or immediately upon submission for early termination or halt. If the device is not registered within a year, the documents become public automatically. Until EUDAMED is fully functional, MDCG 2021-1 Rev. 1 advises using national procedures for submission and the CIRCABC directory for publication. Additionally, the 2023 Commission guidance provides structured methods for content and identification of clinical investigation reports and summaries.

AUSTRALIA

Guidance on Advertising personalised medical devices

Sponsors of medical devices must follow the rules for advertising therapeutic goods to consumers. There are legal requirements you must meet under:

The Therapeutic Goods Act 1989- external site (the Act)

The Therapeutic Goods Advertising Code (the Code)

Other relevant laws including the Competition and Consumer Act 2010.

The guidance document mentioned that What you can advertise, what you can’t advertise and Examples of Compliant, Non-compliant.

Annual reports: Sponsors of certain medical devices are required to submit annual reports

Sponsors of certain medical devices are required to submit annual reports for the first three years of inclusion in the Australian Register of Therapeutic Goods (ARTG).

Annual reports should cover the period from 1 July to 30 June and are due on 1 October each year. Your first report should be for a period of at least six months, but not longer than 18 months. 

Subsequent reports are to be provided by 1 October for a further 2 years.

Things to include in your annual report are mentioned in this document

Annual reports must be provided in electronic form and can be emailed to medicaldevicesurveillance@health.gov.au marked for the attention of the Annual Report Coordinator.

Update: Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems

This guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices intended to be used in direct contact with the heart, CCS or the CNS will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Update: Reclassification of medical devices that administer medicines or biologicals by inhalation

This guidance aims to assist sponsors of medical devices that administer medicines or biologicals by inhalation with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 medical devices that administer medicines or biologicals by inhalation will be required to meet regulatory requirements demonstrating the safety and efficacy of the product commensurate with the higher classification (Class IIa or Class IIb).

Guidance on the Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin

This guidance aims to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for Class IIa (low-medium risk) or Class IIb (medium-high risk) devices.

Updated Guidance: Reclassification of spinal implantable medical devices

The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.

From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:

• More detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
• Conformity assessment documents demonstrating procedures appropriate for their classification
• A mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence
• Class IIb spinal fusion devices will need to have specific information in the ARTG entry about the devices that are supplied under the ARTG entry. This includes product names of all devices under each ARTG entry.

Reclassification of active medical devices for therapy with a diagnostic function

This guidance aims to assist sponsors of active medical devices for therapy with a diagnostic function with meeting their obligations and outlines transitional arrangements to help comply with new regulations.

From 25 November 2021 active medical devices for therapy with a diagnostic function will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

Update: Guidance on Medical device labelling obligations

The guidance explains how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.

 Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002- external site (the Regulations) This outlines the requirements for labelling and instructions for use.

Manufacturer obligations

Medical device manufacturers need evidence that they follow the Essential Principles. This including those that relate to labelling and instructions for use.

Clause 13.3 in the Regulations lists all information that must be provided with a medical device. The manufacturer should ensure that all information is in English.

Sponsor obligations

Under Regulation 10.2, sponsors name and address must be all devices they supply within Australia.

This information should be:

• In a manner that allows the sponsor to be readily identified by a user of the device; and
• In a way that is appropriate for the device under Essential Principle 13.2.

Guidance on Regulation of menstrual cups in Australia

The guidance gives a brief outline of the regulatory requirements stated in Therapeutic Goods

Order No.99 – Standards for Menstrual Cups.

Guidance on Supporting documentation for inclusion of a medical device

The guidance aims to help sponsors identify the relevant documentation that will assist them throughout the application, inclusion and post-market processes associated with maintaining a device inclusion in the ARTG.

The information must be provided in addition to the Manufacturer Evidence for Medical Devices (including IVDs) that you submitted to the TGA prior to commencing your device application. The specific documents that you are required to attach are outlined in the final column “Documentation to be provided with the application (Evidence of product assessment)” in the Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs).

Guidance on Boundary and combination products

The guidelines discuss key concepts that will assist manufacturers and sponsors understand which regulatory pathways and requirements will apply to boundary and combination products depending on how they are categorized.

The examples provided are a revised list of common boundary and combination products, and the category under which they are likely to be regulated.

The information is for guidance purposes only. It does not address every aspect of the relevant legislation.

Determinations for Australian conformity assessment bodies

These guidelines describe the processes associated with applying to become an Australian conformity assessment body. The document provides an overview of the process and requirements for applying for a conformity assessment body determination.

Guidance: Should your product be in the ARTG

As a medical device sponsor, you must ensure your device is correctly listed on the ARTG. If incorrectly included, request cancellation via the

• Using the TBS portal- external site; or
• Completing a paper-based form.

The regulatory team reviews ARTG entries and will contact sponsors if any incorrect entries are identified.

Guidance: Varying entries in the ARTG: medical devices and IVDs

This guidance is intended for sponsors seeking to apply for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device.

It is crucial that the information in the ARTG is:

• Kept up-to-date, and
• Accurate from public health, regulatory, and transparency perspectives.

If any information in the ARTG changes, the sponsor must request a variation to the corresponding ARTG entry.

Update: Guidance for eCTD AU module 1 and regional information v3.2

The document provides guidance for compiling an eCTD dossier and the specifications for compiling and validating regulatory activities in eCTD format. It replaces AU eCTD specification Version 3.1 and includes updated information, with a transition plan for implementing version 3.2.

Key implementation timelines:

• AU eCTD version 3.2 becomes effective on 1 February 2025.
• Version 3.1 will be accepted until 31 July 2025, after which older versions (3.0 and earlier) will no longer be accepted.
• Both versions 3.1 and 3.2 will be accepted during the transition period (1 February 2025 to 31 July 2025).

To submit your first regulatory activity in eCTD format, you need to obtain an e-Identifier by emailing esubmissions@health.gov.au, providing details such as the applicant’s name, active ingredient, submission description, and manufacturing site information (if applicable). The e-Identifier is a combination of the letter ‘e’ and six digits (e.g., e123456) and remains valid for the entire product lifecycle unless transferred to a new sponsor.

Update: Guidance on Understanding rules for boundary and combination products

The guidelines help manufacturers and sponsors understand the regulatory pathways for boundary and combination products in Australia. It explains how the Therapeutic Goods Administration (TGA) regulates therapeutic goods, including medicines, biologicals, medical devices, and other therapeutic goods (OTGs), each with distinct requirements. Boundary products, which share attributes of multiple categories, and combination products, which contain more than one therapeutic good, require specific regulatory pathways. The document provides examples and case studies to clarify the applicable regulations and advises referring to relevant legislation or contacting the TGA for further details.

Update: Guidance on Classifying medical devices that are not in-vitro diagnostics (IVDs)

The document helps manufacturers correctly classify their devices as part of the Steps to Supply Medical Device guidance. It does not cover determining whether a product is a medical device, boundary and combination products, or the classification of in vitro diagnostic (IVD) medical devices. Manufacturers are responsible for classifying their devices based on their intended purpose, as classification is key to determining the required regulatory evidence. Identical devices may be classified differently depending on factors like their use, intended users, or location in the body. Devices intended to be supplied sterile or with a measuring function are also subject to classification based on their intended purpose.

BRAZIL

Anvisa clarifies the import of medical device components

Anvisa has updated its guidelines on Operating Authorization (AFE) requirements for special warehouse storage facilities and importers of medical device components. These changes, based on the recently published Collegiate Board Resolutions (RDCs) 860/2024 and 939/2024, apply to finished products regulated by the Agency.

Notice that will select innovative medical devices has more than 100 proposals registered

On January 19th, Anvisa closed registrations for the pilot project that will select innovative medical devices.

In total, 108 proposals were received. The Agency will analyze all projects received. The announcement of those chosen is scheduled for the month of February.

 On November 28 last year, Anvisa published Call Notice 10/2023, which invited interested companies to participate in the pilot project. The objective is to facilitate the development and entry into Brazil of innovative medical devices based on new technologies. 

The idea of ​​the unprecedented project is for the Agency to closely monitor the production of these devices, facilitating their development and entry into the country.

Regulation update: Anvisa updates safety and performance requirements for medical devices

The new resolution revises RDC 546/2021, which replaced the previous standard (RDC 56/2001). The updated essential safety and performance requirements will allow the regulatory authority to evaluate these aspects against new technologies and the diversity of medical devices. The updated requirements will also enable manufacturers to identify the studies and evidence that should support product registration requests in an objective manner, giving more robustness to the documentation submitted to Anvisa.

Anvisa extends the validity period of the Good Manufacturing Practices Certificate to four years

The validity of the Certificate of Good Manufacturing Practices (CBPF) for medical device manufacturers granted through the MDSAP (Medical Device Single Audit Program) was extended from two to four years.

Issues related to in vitro diagnostic medical devices will be updated

Anvisa will update its electronic petition system to comply with RDC 830/2023, which addresses risk classification, notification, registration, labeling, and instructions for use of in vitro diagnostic medical devices and instruments. As a result, from May 29th to June 3rd, petitions related to in vitro diagnostics may be temporarily unavailable. This update is necessary to revise the document lists required for electronic petitions under the new regulation. The update specifies the subjects that will be updated, their respective codes and the type of change to be made.

Anvisa performs maintenance on the documentary repository of medical devices for in vitro diagnostics

Anvisa informs companies that the maintenance of the documentary repository of in vitro diagnostic medical devices is underway. This measure is necessary because the protocols conducted by companies for subject code 80204 – IVD – Availability of Instructions for Use on the Anvisa Portal did not function as expected. Specifically, the instructions for use of the products were not made accessible on the Agency’s portal immediately after the protocol for this subject was submitted.

Update: Standard on safety requirements for medical devices comes into force

The Collegiate Board Resolution (RDC) 848/2024, effective from September 4, 2024, replaces RDC 546/2021 and updates the requirements for demonstrating the compliance of medical devices, including in vitro diagnostic (IVD) devices. The new standard aligns with global advancements and ensures greater safety and effectiveness. Key requirements include:

• Devices must meet their intended purpose under specified conditions.
• They must be safe, function as intended, and have acceptable risks considering the benefits.
• Safety and performance must be supported by clinical data for high-risk devices (classes III and IV).

RDC 848/2024 reflects Brazil’s efforts towards international regulatory alignment, particularly with the International Medical Devices Regulators Forum (IMDRF) and Mercosur countries.

Anvisa reviews and consolidates standards for the Medical Devices area

Anvisa has republished the rule prohibiting the use of mercury-based thermometers and sphygmomanometers in health services. The new Collegiate Board Resolution (RDC 922), issued on September 19, 2024, does not change the existing ban from 2017. This update is part of a review and consolidation process outlined in Decree 12.002/2024, focusing on formal adjustments without altering the original guidelines. The resolution officially revokes RDC 145/2017 but maintains the ban on manufacturing, importing, selling, and using mercury-column devices across Brazil.

ANVISA informs that change in the petition for clinical research of medical devices

 Anvisa informs that requests for clinical research on health products have migrated to the Solicit system. The change aims to improve the experience of the regulated sector, as requests and monitoring of requirements will be done centrally.

Anvisa provides guidance to companies on procedural instructions for notification and registration of medical devices

Anvisa issued Circular Letter to medical device registration and notification holders, outlining procedural instructions for submitting petitions related to medical devices. The circular specifies requirements for sworn translations and legally valid signatures for documentation. It also clarifies the minimum electronic signature standards necessary for interactions with public entities by legal entities. The guidelines were also sent to associations, societies and chambers related to the regularization of medical devices with Anvisa.

CANADA

Guidance on terms and conditions for class II to IV medical devices

The guidance document explains the process for imposing, amending, or removing terms and conditions (T&Cs) on Class II to IV medical device licenses under section 36 of the Medical Devices Regulations (MDR). It covers the purpose of T&Cs, the procedure involved, and opportunities for license holders to be heard. Exclusions include T&Cs for in vitro diagnostic device lots (section 37) and devices authorized for urgent public health needs. The MDR defines medical devices but excludes those intended for animals.

Updated: Regulatory enrolment process (REP)

The Regulatory Enrolment Process (REP) streamlines the filing and processing of regulatory information related to companies, dossiers, products, regulatory activities, and transactions. It uses web-based templates to structure information, replacing Health Canada’s existing application and fee forms. REP supports a unified submission intake across product lines and automates the receipt and import of regulatory transactions into Health Canada’s repositories.

Drug and medical device databases

Health Canada’s drug and medical device databases provide information on prescription and non-prescription pharmaceuticals, biologics, radiopharmaceuticals, and medical devices for humans and animals. These databases aim to increase transparency and accessibility for stakeholders and the public, with Health Canada recommending them as the primary resource for accessing such information.

Updated: Regulatory enrolment process

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. The decision is based on the results of a pilot project, which began in November 2019 and will end in June 2024. About 40 companies participated in the pilot. The pilot was positive. All medical device companies are now invited to begin to use this process beginning in July 2024.

Guidance on Medical devices for an urgent public health need

On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (regulations) came into force. This guidance explains how to apply for an authorization to import or sell UPHN medical devices. Included are devices that are part of a system, test kit, medical device group, medical device family or medical device group family. To obtain an authorization to import or sell a UPHN medical device, manufacturers must submit an application to the Minister. This guidance outlines the information required to obtain an authorization to import and sell UPHN medical devices in Canada.

Updated: Common Electronic Submissions Gateway 

For regulatory transactions that can be currently sent to us through the gateway, consult the following guidance documents (available upon request) on the filing submissions electronically web page:

• Preparation of regulatory activities in eCTD format
• Preparation of regulatory activities in non-eCTD format

The Update also provided links for the information on how to register, connect and submit regulatory transactions using the gateway.

Regulatory enrolment process (REP) 

 The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to:

• Company
• Dossier and product
• Regulatory activity
• Regulatory transaction

REP consists of web-based templates that capture information in a structured format. This process enables a shift towards a common submission intake across product lines and allows Health Canada to:

• Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG)
• Automate the import of regulatory transactions into its repositories

CHINA

NMPA released draft for comments on the “Guiding Principles for Technical Review of Registration of Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories”

This guidance applies to ophthalmic phacoemulsification and vitrectomy equipment and accessories. Including: ophthalmic ultrasound surgical equipment, classification code 16-05-01; other ophthalmic treatment and surgical equipment (vitreous cutter), classification code 16-05-05; ophthalmic treatment and surgical auxiliary equipment (intraocular illuminator, vitrectomy head, injection and suction instruments, accessories for ophthalmic phacoemulsification surgical instruments), classification code 16-05-06.

This guideline does not include the requirements for the posterior segment laser photocoagulation function. If the product integrates the laser photocoagulation function, you should refer to the relevant requirements of the “Guiding Principles for Registration Review of Ophthalmic Laser Photocoagulation Machines”.

This guideline does not include requirements for changes to registration application materials. Registration change application materials may refer to the applicable content in these guidelines.

NMPA released draft for comments on two guiding principles including the “Guiding Principles for the Registration and Review of Clinical Evaluation of In Vitro Diagnostic Reagents for Tumor Screening”

Tumor screening generally targets tumors with high morbidity and mortality. Effective treatments are available when related tumors are diagnosed at an early stage. Patients will benefit better if they are diagnosed clearly at an early stage than if they are diagnosed at a later stage. Effective treatments Screening methods can reduce disease morbidity and mortality and improve the quality of life of diseased people by achieving early detection, early diagnosis, and early treatment of diseases.

This applies to reagents that use immunohistochemistry to detect PD-L1 in pathological tissue sections. Such reagents are specific monoclonal or polyclonal antibodies, or detection reagents in the form of a kit in which the antibody is packaged together with a chromogenic system, control reagents, quality control slides (if any) and other auxiliary reagents, and are used for immune checkpoint inhibition. Companion diagnostics or complementary diagnostics.

Announcement of the Center for Device Review of the State Food and Drug Administration on the Release of Guiding Principles for Registration Review of Remote Monitoring Systems (No. 5, 2024)

This guideline applies to remote monitoring equipment (classification code 07-08-02) and remote monitoring software (classification code 21-03-01) in the “Medical Device Classification Catalog”. Other systems or software with remote monitoring functions can refer to this guide. Applicable portions of the Guiding Principles.

Physiological parameters that can be monitored by remote monitoring equipment usually include ECG, EEG, non-invasive blood pressure, blood oxygen saturation, body temperature, respiration, pulse, carbon dioxide or other physiological parameters. Common patient monitoring terminals include physiological parameter analysis and measurement equipment (classification code 07-03), monitoring equipment (classification code 07-04), telemetry and central monitoring equipment (classification code 07-08), etc.

Notice on the public solicitation of opinions on the “Guiding Principles for Registration Review of Estrogen Receptor and Progesterone Receptor Antibody Reagents and Test Kits (2023 Revised Edition)”

Estrogen Receptor (ER), Progesterone Receptor (PR) antibody reagents and detection kits refer to the use of immunohistochemistry to detect estrogen receptors or progesterone receptors in pathological tissue sections. Detection reagents. Such reagents are specific monoclonal or polyclonal antibodies, or detection reagents in the form of a kit in which the antibody is packaged together with a color development system, control reagents, quality control tablets (if any) and other auxiliary reagents, and are used for the detection of breast cancer patients. Prognosis judgment and medication guidance. The ER mentioned in this guideline is ERα. The guideline only includes the requirements for some items in the registration application materials for estrogen receptor, progesterone receptor antibody reagents and detection kits, and is applicable to products undergoing product registration and related change registration. Other matters not covered (including product risk analysis data, etc.) should comply with relevant regulatory requirements such as the “Registration and Filing Management Measures for In Vitro Diagnostic Reagents” (hereinafter referred to as the “Measures”).

NMPA released draft for comments on the “Guiding Principles for Registration and Review of Clinical Evaluation of In Vitro Diagnostic Reagents for Colorectal Cancer Screening ”

The guideline is applicable to the in vitro qualitative detection of relevant markers derived from stool samples and in vitro diagnostic reagents used for colorectal cancer screening. A positive result indicates a higher risk of colorectal cancer or advanced adenoma, and a diagnostic colonoscopy should be performed. Product test results cannot replace colonoscopy. For other sample types, some requirements may not be fully applicable or the content described in this article is not comprehensive enough. Applicants can refer to this guideline to evaluate the applicable parts based on product characteristics or supplement other evaluation materials for corresponding verification.

Notice from the Device Review Center of the State Food and Drug Administration on the release of the guiding principles for the registration review of four medical device products including positron emission magnetic resonance imaging systems (No. 8, 2024)

The guideline applies to PET/MR systems. PET/MR can be divided into split type, PET plug-in type and fully integrated type according to different product structures. The PET/MR system referred to in this guideline is fully integrated/one-piece PET/MR, split type and plug-in type. PET/MR systems can refer to this guideline. The guideline applies to single-photon emission X-ray computed tomography systems. The Imaging system of single photon emission and X-ray computed tomography (herein referred to as “SPECT/CT”) combines the single photon emission computed tomography system (SPECT) and the X-ray computed tomography system. (CT), providing registration and fusion of physiological and anatomical information. The guiding principle applies to ventilators. According to the “Medical Device Classification Catalog”, the management category is Category III, and the classification codes are 08-01-01 Treatment Ventilator, 08-01-02 Emergency and Transfer Ventilator, 08-01- 03 high-frequency ventilator, 08-01-04 household ventilator (life support).The nitric oxide therapy device delivers controllable concentration of nitric oxide gas to the patient’s respiratory tract, while monitoring the concentrations of nitric oxide, nitrogen dioxide, and oxygen, and providing corresponding alarm functions. Some products have a gas generator for producing nitric oxide.

Notice from the Device Review Center of the State Food and Drug Administration on the release of key points for the technical review of laser equipment for myopia and amblyopia (No. 6, 2024)

This review point applies to the registration of laser equipment for myopia and amblyopia that irradiates the fundus through the pupil. It is based on the “Medical Device Classification Catalog”, “Guiding Principles for Classification and Definition of Medical Device Products for Myopia Control and Amblyopia Treatment” (Draft for Comments) and previous Definition document, the classification code of this type of product is 16-05, and the management category is Category III. These review points are intended to guide registration applicants in carrying out product design and development work and reparing product registration application materials.

NMPA released draft for comments on the “Guiding Principles for Registration Review of Clinical Trials of Peripheral Drug-Coated Balloon Dilatation Catheters

The guidelines apply to conventionally designed peripheral drug-coated balloon dilation catheters using percutaneous transluminal angioplasty (PTA) for peripheral above-knee femoropopliteal artery occlusive disease, peripheral infrapopliteal artery occlusive disease, and peripheral autologous Arteriovenous fistula dialysis access stenosis and expansion of lesions. According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 03-13-06, and the management category is Class III. If a drug-coated balloon catheter has a special design and application claims, separate clinical trials should be formulated based on its own design features and clinical claims. This guideline gives the general requirements for such products, and takes the above-knee femoropopliteal artery drug-coated balloon dilatation catheter and the peripheral arteriovenous fistula drug-coated balloon dilation catheter as examples (see attachment for details) to explain the requirements for peripheral For recommendations on specific elements to consider in clinical trials of common categories of drug- coated balloon dilatation catheters, products of the same type can refer to the relevant applicable sections.

Notice on soliciting proposals for the 2025 national medical device clinical evaluation standardization technology focal unit standard pre-project proposal

The field of quality management and general requirements for clinical evaluation of medical devices (including clinical trials) and clinical trials of in vitro diagnostic reagents does not include clinical evaluation requirements for specific products.

• Application materials
  • “Medical Device Standard Project Proposal Form” (see Attachment 1, which needs to be stamped with the official seal of the unit).”Registration Form for Medical Device Standard Drafting Units” (see attachment 2, which must be stamped with the official seal of the unit).
• Application requirements
  • Standard draft: clearly proposes the main chapters and the main technical content specified in each chapter.
  • Please fill in the above documents before June 30, 2024, and send the scanned copy to the secretariat contact email. Project proposals received after this period are carried over to the following year.

Announcement of the State Food and Drug Administration, National Health Commission, and National Bureau of Disease Control and Prevention on the Issuance of Regulations on the Management of Emergency Use of Medical Devices (Trial) (2023 No. 150)

Medical devices intended for emergency use shall be medical devices for which similar products have not been registered in China, or although similar products have been registered, the product supply cannot meet the use needs of particularly major public health emergencies or other emergencies that seriously threaten public health.

The emergency medical devices referred to in this regulation do not include Class I medical devices.

Notice on collecting information from relevant companies and units participating in the preparation of three in vitro diagnostic reagent registration review guidelines including the “Human KRAS Mutation Gene Detection Reagents (PCR Method) Registration Review Guidelines

According to the 2024 guiding principles, the plan is prepared. In order to further improve the technical review work of related products, the center has now launched the “Guiding Principles for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)” and “Glucose-6-phosphate Dehydrogenase” Preparation of “Guiding Principles for Registration Review of Testing Reagents” and “Guiding Principles for Traceability Registration Review of Enzyme Testing Reagents”. Units participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate.

Units interested in participating in the preparation work are requested to fill in the participating unit information collection form (attachment) and submit it to our center in electronic form before March 29, 2024. Please name the email subject in the format of “XX Guiding Principles + Unit Name”.

Notice on soliciting information from relevant companies and units participating in the preparation of two in vitro diagnostic reagent registration review guidelines including the “Registration Review Guidelines for Human T Lymphocytic Leukemia Virus Antibody Detection Reagents”

According to the 2024 guiding principles preparation plan, in order to further improve the technical review work of related products, our center has now launched the “Guiding Principles for Registration Review of Human T Lymphocyte Leukemia Virus Antibody Detection Reagents” and “Human Leukocyte Antigen (HLA) Gene DNA” Preparation of “Guiding Principles for Registration Review of Typing Test Reagents”. Units participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate.

Units interested in participating in the preparation work are requested to fill in the participating unit information collection form (attachment) and submit it to our center in electronic form before March 29, 2024. Please name the email subject in the format of “XX Guiding Principles + Unit Name”.

Notice from the Device Review Center of the State Food and Drug Administration on the release of the Guiding Principles for Registration Review of High-Frequency Surgical Equipment (2023 Revised Version)

The guideline applies to high-frequency surgical equipment. According to the definition of 201.3.224 in the GB 9706.202 standard, high-frequency surgical equipment mentioned in this guideline refers to “medical electrical equipment that generates high-frequency current and is expected to use high-frequency current for surgical operations, such as cutting (cutting) biological tissue or solidification)”. It with special clinical use methods or specific indications (such as plasma surgical equipment, large vessel closure equipment, etc.).

The guideline does not apply to radiofrequency ablation equipment for gynecology, oncology or heart, as well as non-ablative radiofrequency treatment equipment that uses radiofrequency energy for plastic surgery/beauty. It does not apply to electric heating and cauterization equipment and hyperthermia products. It does not include the requirements for surgical accessories and neutral electrodes in high-frequency accessories. If the structural composition contains surgical accessories and neutral electrodes.

Interpretation of “Guiding Principles for Medical Device Usability Engineering Registration Review”

The guiding principles apply to registration applications for Class II and Class III medical device availability projects, but do not apply to in vitro diagnostic reagents. Registration applicants can refer to the guiding principles to carry out usability engineering work for all medical devices.

Medical device usability engineering refers to the comprehensive use of knowledge about human anatomy, physiology, psychology, behavior, culture and other aspects of capabilities and limitations to design and develop medical devices to enhance the usability of medical devices.

Usability refers to the user interface features that ensure the safety, effectiveness and ease of use of medical devices when users are expected to use the medical devices normally under expected usage scenarios. The core elements of usability include users, usage scenarios and user interfaces, focusing on the safety and effectiveness of normal use of medical devices.

Notice on collecting information from relevant enterprises and units participating in the preparation of six guiding principles including the “Guiding Principles for Registration and Review of Metal Bone Needles

Participating unit information collection form and units participating in the preparation of Guidelines for registration review of metal bone needles, memory alloy rib plates, Skull Repair Mesh System, sternum strapping/grasp fixation system, Filling Materials for Oral Hard Tissue and Dental Resin Filling Material Products (2024 Revised Edition).

Notice of the Device Review Center of the State Food and Drug Administration on the release of guiding principles for registration review of medical device availability engineering

The guiding principle applies to registration applications for Class II and Class III medical device availability projects, but does not apply to in vitro diagnostic reagents. Registration applicants may refer to this guideline to carry out usability engineering work for all medical devices.

It is formulated based on current regulations, mandatory standard systems, and current scientific and technological capabilities and cognitive levels. With the continuous improvement of regulations and mandatory standard systems and the continuous development of scientific and technological capabilities and cognitive levels, these guiding principles are relevant The content will also be adjusted in due course.

It is guidance document for registration applicants, reviewers and inspectors. It does not involve administrative approval matters, nor is it enforced as a regulation. This guiding principle should be used under the premise of complying with relevant regulations.

Notice from the Device Review Center of the State Food and Drug Administration on the release of the guiding principles for the registration review of four medical devices including corneal topographs

The guideline applies to equipment that uses the working principle of optical imaging/measurement to obtain the shape of the cornea surface through non-contact methods. According to the 2017 version of the “Medical Device Classification Catalog”, this type of equipment is managed as Class II medical devices, covering applicable products with a classification code of 16-04-12.

The guideline applies to the design and implementation of animal experiments on multiport laparoscopic surgical systems. It is intended to guide registered applicants to scientifically conduct animal experimental research on surgical systems. It is not applicable to experiments conducted on non-living animals, isolated tissues or organs. Research.

The guideline applies to three-dimensional endoscopes in multiport laparoscopic surgery systems. It is applicable to those with a robotic arm interface that can be installed on the robotic arm and controlled by the system. Special endoscopes are also suitable for general endoscopes that can be used independently without being controlled by a robotic arm.

The guideline applies to medical devices whose products contain light sources (including laser and non-laser), and the light emitted by the light source is expected to act on the human body. It includes both medical devices that use light sources to achieve their main intended use, such as endoscope cold light sources, laser surgical equipment, etc.

Notice of the Device Evaluation Center of the State Food and Drug Administration on the release of the recommended path for clinical evaluation of products related to the medical device classification catalog (supplement in 2024)

In 2024, based on the latest product development and application status, clinical evaluation regulatory scientific research results and technical review work practices, the clinical status of surgical navigation systems, isolated organ mechanical perfusion and transfer equipment, plastic implant wires and other products will be further clarified Evaluate recommended paths.

Notice on the public solicitation of opinions and suggestions on “Guiding Principles for Registration and Review of Laparoscopic Surgery Systems Part 5: Systems and Software”

This review point applies to multiport laparoscopic surgery systems (referred to as surgical systems). According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 01-07-03, and the management category is Class III.

The key points of this review are general requirements for laparoscopic surgery system products. The registration applicant should determine whether the content is applicable based on the specific characteristics of the product. If it is not applicable, the reasons and corresponding scientific basis must be explained in detail, and based on the product’s Specific characteristics will enrich and refine the content of the registration application materials.

Announcement of the State Food and Drug Administration on standardizing the classification and definition of medical device products (No. 59, 2024)

To strengthen the classification management of medical devices, further standardize the classification and definition of medical device products, and optimize the work procedures, in accordance with the “Medical Device Supervision and Administration Regulations, “Medical Device Registration and Filing Management Measures”, “In Vitro Diagnostic Reagent Registration and Filing Management Measures”, “Opinions on Further Strengthening and Improving the Classification Management of Medical Devices” and other relevant requirements, the relevant matters are announced in the document.

COLUMBIA

The platform for reporting the semantic standard of Medical Devices comes into operation

The Ministry of Health and Social Protection and the National Institute for Food and Drug Surveillance –Invima, inform users that, as of February 8, 2024, the web platform for reporting the semantic standard of medical devices and in vitro diagnostic reagents, in compliance with Resolution 1405 of 2022.

Invima changes the format for requesting audit and certification procedures

The National Institute for Food and Drug Surveillance (Invima) informs users that, to optimize the management of audit and certification procedure requests, the format for requesting procedures, visits, certifications, and certificates has been updated to ASS-AYC-FM33.

For medical devices and other technologies: ASS-AYC-FM161 – Request for audit and certification procedures – medical devices and other technologies

Guide for the implementation of requirements for certification visits of medical devices on hearing aid measurement

The guide is intended for establishments involved in manufacturing, assembling, or repairing over-the-counter hearing aids within the national territory. It outlines the necessary steps to ensure these hearing aids meet quality standards designed to aid individuals with hearing impairments. It provides instructions on adhering to the requirements of Resolution 5491 of 2017, which covers the opening and operation of these establishments. The guide also offers recommendations for maintaining compliance with certification standards, which are valid for five years.

CZECH REPUBLIC

English versions of information and guidelines for advertising medical devices and in vitro diagnostic medical devices

The Institute informs that it has published English versions of information and advisory guidelines on advertising of medical devices and in vitro diagnostic medical devices, which are available on the Dozor nad rekloum | NISZP.

Assignment of power of attorney in the Information System of Medical Devices (ISZP)

If you want to assign a power of attorney (PM) to perform actions in the ISZP, you request its assignment electronically in the ISZP interface.

The condition for launching a request for PM approval is that the entities that will figure in the power of attorney process have an account in the external identities portal, through which you request access to ISZP and at the same time set up user accounts.

If the above conditions are met, then you can start a request for PM approval in ISZP . The course of the process depends on the way you log in to ISZP.

The procedure of manufacturers of custom-made products after the launch of ISZP

The announced activity of the manufacturer of the product to order will be migrated to ISZP from RZPRO with generic groups of GMDN nomenclature. With regard to § 73, paragraph 2 of Act No. 375/2022 Coll. The Institute migrates all data already reported by the manufacturer of the product to the ISZP. Pursuant to Section 8, Paragraph 4 of the same law, the manufacturer has the obligation to notify the Institute of his activity within 30 days of its commencement, as well as the list of generic groups of manufactured products within 6 months of the start of production and the end of this activity.

Following the migration of data, the Institute recommends that manufacturers of custom-made devices request access data to ISZP and check their data, or submit a change notification within a period of one year, by which they report the generic group according to the European Nomenclature of Medical Devices (EMDN). The EMDN number is uploaded directly to the ISZP in the notification guide.

Updating the process of requesting access to ISZP

The section for the regulation of medical devices proceeded to re-evaluate the requirements of applications for access to the ISZP.

The request for access is available at SÚKL Access (sukl.cz)

Commission survey to extend the scope of the regulation on electronic instructions for use of medical devices

In accordance with the discussions on the scope of the implementing regulation (EU) 2021/2226 on electronic instructions for use of medical devices, the Commission has prepared a survey targeting healthcare workers and experts in healthcare facilities. The survey aims to gather feedback on the potential extension of the regulation’s scope to include all devices intended for professional use. Additionally, it includes an open-ended question to collect input on products intended for non-professional use.

FINLAND

Notification form for interruption or cessation of medical device supplies published

The European Commission has published a form for medical device manufacturers to notify anticipated supply interruptions or cessations starting January 10, 2025. Under Article 10a of Regulation (EU) 2024/1860, manufacturers must notify if such events could foreseeably cause serious harm to patients or public health in any Member State. Notifications must typically be submitted at least six months in advance, except in exceptional circumstances.

The EU Commission proposes changes to the MD and IVD regulations

The EU Commission has published a draft regulation that contains changes and clarifications to the MD and IVD regulations. The proposed changes are related to the phased introduction of the Eudamed database and the transition periods of the IVD regulation.

New obligations are proposed for manufacturers and economic operators to provide advance information related to the availability of devices to the authorities in situations where there are significant interruptions in availability or the production of the device ends, and this is estimated to cause a significant disruption to healthcare.

Fimea analyzes the effects of the changes proposed by the EU Commission on Finnish operators.

A new online information package about clinical trials with medical devices

The requirements for clinical trials performed with medical devices have become stricter and the need for advice and guidance regarding the trials has increased. Frequently asked questions about clinical trials have now been compiled on a new website.

Frequently asked questions and answers have been compiled on the website regarding 

• General information about clinical trials
• Application paths for clinical trials
• Application form and application attachments
• Schedules
• Other research-related reporting

The website will be updated as needed. If the answer to the question cannot be found on the website, questions can also be sent by email to laitetutkimus@fimea.fi .

The new website provides information on marketing requirements for medical devices

New EU regulations and updated national legislation have brought new requirements to the marketing of medical devices. Fimea has put together a condensed information package on the marketing rules for medical devices in Finland on its new website. The website provides information on the marketing requirements for medical device operators presented in EU regulations and national legislation.

Information can be found on the website:

1. on regulations concerning the marketing of medical devices
2. on national requirements for marketing
3. marketing claims
4. tips for successful marketing of medical devices.

The EU Parliament approved the proposed changes to the MD and IVD regulations

The amendment decree introduces new obligations to provide advance information related to the availability of devices to the authorities when the interruptions in the availability of the device or the end of production are estimated to cause significant disruptions to healthcare. 

The changes regarding the transitional periods of the IVD Regulation are related to the additional time given to manufacturers for the application of the new regulation. The new transition periods depend on the type of device and especially the risk category according to the IVD Regulation.

The information of operators registered with Fimea for medical devices is available online

Operators in the medical device sector must register either in the public European EUDAMED database or in the national CERE register. In the future, Fimea will make information about operators registered in the CERE register publicly available in a list format, providing open access to this information to support procurement units and other stakeholders. This publication ensures equal treatment for all operators, as the EUDAMED database is also publicly accessible regarding operator data.

Medical device operator: check the information entered in the register for the control fee to be confirmed in 2025

Under Section 50 of the Medical Devices Act (719/2021), Fimea charges a monitoring fee to medical device operators who must report annually, with fees applied separately for each registered role (e.g., distributor and manufacturer). Operators must update their information in Fimea’s register by December 31, 2024, as the 2025 monitoring fee will be based on the data available by that date. The fee will still be charged unless the operator submits a notification of activity cessation by December 31, 2024, either electronically in the CERE or EUDAMED databases, or in writing to Fimea. The fee is waived if Fimea confirms the end of operations by the deadline.

Notification of anticipated interruption or cessation of deliveries of medical devices

Amendment Regulation (EU) 2024/1860 requires medical device manufacturers to notify authorities of anticipated supply interruptions that could harm patients or public health. This obligation starts January 10, 2025, with notifications due at least six months in advance, except in exceptional cases.

Notifications must be sent to the competent authority in the manufacturer’s member state, directly supplied economic operators, healthcare units, and professionals. Importers and distributors must relay disruption notices to their supply chain partners.

Manufacturers must update the EUDAMED database for any changes, including market withdrawal. A reporting form and guidance will be provided by the European Commission to support compliance.

FRANCE

European regulation relating to medical devices: end of the transition

Concerning medical devices, the amending regulation relating to medical devices published in March 2023 provided for an extension of transitional measures in order to ensure continuity of care and the availability of devices in optimal safety conditions. May 26, 2024 marks an important step in the transition between the old and new regulatory text: the deadline for submitting a certification application for a medical device. From this date, no medical device may be placed on the market if its manufacturer has not either satisfied the conditions of EU Regulation 2017/745 or filed an application for certification under the new regulation with a notified body (ON). Between May 26 and September 26, the ON will evaluate the request. As of September 26, 2024, in addition to medical devices that are already compliant, only those for which a certification contract has been established between the manufacturer and its ON may be placed on the market.

Certification of medical devices: a second European notified body for France

On April 23, 2024, Afnor certification was designated a notified body (ON) in France, under the European regulation (EU 2017/745) on medical devices (MDR). Depending on its authorizations, it will evaluate medical devices and give their manufacturers authorization to affix a CE marking to them. It thus completes the existing offer which was based, for France, solely on the GMED.

GERMANY

Frequently asked questions (FAQ) Changes due to DigiG

A central concern of DigiG is the further development of the provision of digital health applications (DiGA). DiGA should be better integrated into care processes and also enable more complex treatment processes. The following FAQ contains answers to the most important changes related to DiGA.

Request for classification and/or delimitation

For a delimitation or classification decision by the BfArM, an informal application for classification and/or delimitation must be submitted to the BfArM in accordance with Section 6 Paragraph 2 of the Medical Devices Law Implementation Act (MPDG). In principle, a notified body, the manufacturer, its authorized representative or the responsible state authority are entitled to apply.

The delimitation of a product is based on the definition of medical devices in Article 2 No. 1 of Regulation (EU) 2017/745 (Medical Device Regulation, MDR). The classification is carried out according to the classification rules of Annex VIII of the MDR.

Incident reporting by manufacturer and authorized representatives

Until the European database for medical devices is fully functional in accordance with Article 33 of Regulation (EU) 2017/745 (MDR), the reporting form below must be used

• Reports of serious incidents in accordance with Article 87 MDR by manufacturers (for medical devices excluding in-vitro diagnostics)
• Reports of serious incidents in accordance with Article 82 of Regulation (EU) 2017/746 – IVDR (for in-vitro diagnostics)

Reporting of serious adverse events (SAEs) and product defects ( DDs ) in the context of a clinical trial in accordance with MDR and MPDG

Since the MDR came into force on May 26, 2021, for all clinical trials that must be applied for or reported to the higher federal authority, serious adverse events (SAEs) and product defects (DDs ) must be reported in accordance with the European Regulation 2017/745 ( MDR ) in conjunction with the Medical Devices Implementation Act ( MPDG ).

Below link provides information on Which reporting forms should be used for serious adverse events (SAEs) from May 26, 2021 and What reporting deadlines must be observed for serious adverse events (SAEs ) and product defects ( DDs ) from the date of application of the MDR.

Statistical requirements for applications for authorisation of a clinical trial on medical devices

In accordance with DIN EN ISO 14155 standards for clinical trials of medical devices on humans, the statistics of a clinical trial must meet scientific rigor requirements. Therefore, DIN ISO 14155 includes relevant sections addressing these requirements. The federal authority recommends considering the specified points concerning required information in the test plan when planning the statistics.

HONG KONG

“Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)” has been added

The Supplementary Information Sheet for Medical Devices Procured by the Hospital Authority (HA)(MD111) on this page are relevant to device(s) which had been procured by the Hospital Authority. When submitting a medical device listing application, the applicant should include the duly completed Supplementary Information Sheet along with the relevant listing application forms and required documents. Applicants are also advised to take reference to documents issued under the Medical Device Administrative Control System when completing their medical device listing application.

The Code of Practice “Code of Practice for Listed Distributors of Medical Devices” (COP- 05) has been issued

The purpose of this document is to stipulate the requirements which the Listed Distributor of medical devices has to comply with. Distributors are listed on the List of Distributors by their names, telephone numbers, addresses and Listing Numbers.

The Listed Distributor needs to demonstrate its ability to provide medical devices under the Medical Device Administrative Control System (MDACS) requirements.

This document should be read in conjunction with Guidance Note GN-09 (Guidance Notes for Listing of Distributors of Medical Devices

Introduction of the new Medical Device Information System

The Medical Device Division is going to introduce a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

Announcement of the acceptance of marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore under the Medical Device Administrative Control System (MDACS)

Starting from 2 April 2024, the Medical Device Division (MDD) accepts the marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.

The Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders

The Medical Device Division has introduced a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

Application for the Listing of Class II/III/IV General Medical Devices (MD101)

Medical Device Administrative Control System Application for the Listing of Class II/III/IV General Medical Devices

HUNGARY

Guidance for the Transition of clinical trials from the Clinical Trials Directive to the Clinical Trials Regulation

From 31 January 2025 onwards sponsors are requested to transition to the legal framework of the CTR the ongoing clinical trials that are currently under the regime of the Clinical Trials Directive (CTD) and expected to be ongoing after 30 January 2025.

ICELAND

Submissions for marketing authorizations

RMS slots from second quarter of 2025 are now open for requests. If any slots open up sooner, an announcement will be posted on this website. Slot requests are also applicable for national procedures.

Apply to please fill out the request form and email it to ima@ima.is.

INDIA

CDSCO released Notice on Online application for Neutral Code for manufacturing of Medical Devices for export purpose

In order to streamline the regulatory submission procedure, for issuance of Neutral code to the applicant for manufacturing of Medical Devices for export purpose is now functional through Online system of Medical Devices portal (https://cdscomdonline.gov.in). The applicants seeking for Neutral code shall now apply through online portal as per the checklist provided on the portal.

Circular- Testing and evaluation of Medical Devices/ In-Vitro Diagnostics by Medical Devices Testing Laboratory in the Country

In order to ensure the quality, safety and performance of Medical devices(MD)/ Invitro diagnostics (IVDs), the Ministry of Health and Family Welfare, Government of India has granted registration of Laboratory for carrying out Test or Evaluation of a Medical Device on behalf of manufacturer, to strengthen the testing facility in the country.

India launches online portals for adverse drug monitoring and Pharmacopoeia

The Indian government has introduced two new online portals: one for the adverse drug monitoring system (ADRMS) and another for accessing Indian Pharmacopoeia (IP) standards. The ADRMS portal, described as India’s first medical product safety database designed specifically for the Indian population, aims to simplify the reporting of adverse events related to medicines and medical devices. It will streamline the process for patients, caregivers, and healthcare professionals, and enable pharmaceutical industries to report adverse events directly.

Uniform Code for Marketing Practices in Medical Devices (UCMPMD) 2024

The Department of Pharmaceuticals (DoP) in India has introduced the Uniform Code for Marketing Practices in Medical Devices (UCMPMD) to ensure transparent and accountable marketing of medical devices. Under this code, medtech companies must report the distribution of samples and spending on activities like continuing medical education, uploading this data to the UCMPMD portal within two months after each financial year. The code limits promotions, such as prohibiting events abroad and restricting gifts, travel, and hospitality for healthcare professionals. It also outlines processes for handling complaints, penalties, and appeals for code violations.

Medical Device Adverse Event Reporting Form

The form is intended to collect information on Medical Devices Adverse Event in India. The form is designed to be used by Manufacturer/Importer/ Distributor of Medical Devices and Healthcare Professionals with direct/indirect knowledge of Medical Devices Adverse Event.

IRELAND

Guide to Clinical Investigations Carried Out in Ireland

The guide provides an overview of the legislation on clinical investigations (CIs) involving medical devices. The guide also provides guidance on how to submit applications to carry out CIs in Ireland to the Health Products Regulatory Authority (HPRA). The guide is primarily targeted towards CI sponsors (e.g. manufacturers, academic groups, clinical research organizations), who wish to carry out CIs involving medical devices in Ireland. The information may also be useful for ethics committees and other stakeholders.

ITALY

Approval of the “Guidelines for the correct labeling of medical surgical devices”

The Director General’s decree of December 17, 2024, approved guidelines for the correct labeling of medical-surgical devices. These guidelines aim to protect consumer and professional health through responsible purchasing and use, while helping marketing authorization holders comply with regulations and avoid legal penalties under Legislative Decree 179/2021.

The guidelines address common application issues and incorporate updates from European legislation. They cover the entire lifecycle of marketing authorizations, from application submission to cessation, and include provisions for digital labeling to reduce packaging while ensuring adequate consumer information.

Custom-made medical devices, the deadlines for registration in the new lists of manufacturers already registered have been extended

The new online service was activated starting from 25 September 2023, based on requests from some trade associations, which expressed the need for additional time to complete the transition to the new system, the date initially foreseen has been extended to May 1, 2024 .

After this date, therefore starting from 2 May 2024, the pre-existing lists relating to manufacturers of customized medical devices will no longer be available for consultation on the institutional website of the Ministry of Health.

Medical devices, obligations of distributors and importers

The MDCG 2021-27 guideline provides clarifications relating to the obligations for importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). In particular, the document sets out details on the operational and practical implementation of Articles 13 and 14 and other related obligations on importers and distributors.

Update of expired (AI)MDD certificates

The national database of medical devices, already adapted last October to Regulation (EU) 2023/607 to allow the updating of expired CE certificates, presented some technical difficulties which, in some cases, made correct updating difficult of information.

It is now possible, and will be for the entire transitional period, to update the expired certificates issued pursuant to the Directives and register the devices already placed on the market in the EU territory for making available on Italian territory.

JAPAN

Publication of foreign manufacturer certification/registration number

Certification or renewal of certification of foreign manufacturers of medical devices is based on the completion of the processing of certification, registration, renewal, addition or change of classification, notification of change, and notification of abolition as of the date of publication, and each time when applying for certification, registration, manufacturing and sales approval, etc. Manufacturers and distributors who import pharmaceuticals, medical devices, etc. into Japan are requested to confirm the certification/registration status directly with the foreign manufacturer concerned.

Updated information on compassionate clinical trials (drugs, equipment, and recycling)

A system has been introduced to provide unapproved drugs, devices, and regenerative medicine products to patients who do not meet clinical trial criteria for life-impacting diseases with no effective treatments. This compassionate use aims to balance the risks and expected therapeutic benefits without hindering the development of these unapproved products.This system offers investigational drugs, devices, and products within clinical trials for severe diseases, targeting the final stage of domestic development. It applies to trials that have been or are being conducted (post-enrollment), where the likelihood of patient benefit is relatively high.

LATVIA

The State Medicines Agency (ZVA) invite all distributors of medical devices to register in the LATMED database

The State Medicines Agency (ZVA) reminds that all distributors of medical devices must register in the LATMED database of the Medical Devices Register.

To register in the LATMED database, we invite all distributors of medical devices to submit a ZVA application by sending it to info@zva.gov.lv and specifying the following information:

• company name (trader’s company);
• registration number;
• legal address;
• telephone number and electronic mail address;
• the name and legal address of the manufacturer(s) of the distributed medical devices;
• classification class(es) of common medical devices (please note that specific names of medical devices do not need to be specified).

LITHUANIA

The validity of medical device certificates has been extended

Regulation (EU) 2017/745 sets out the cases and conditions when certificates of conformity that have expired are considered valid. Certificates of compliance issued for high-risk medical devices are valid until 12/31/2027, for medium and lowest-risk medical devices – until 12/31/2028. There are two different validity schemes for compliance certificates, i.e. certificates that expired before 03/20/2023 and certificates that expired after 03/20/2023.

https://vaspvt.lrv.lt/lt/naujienos/pailgintas-medicinos-priemoniu-sertifikatu-galiojimas

MALAYSIA

Placement of HIV self-test (HIVST) kit in Malaysia market

The document is written to guide the establishment on both pre-market, placement on the market and post-market requirements including requirements on registration of HIVST, licensing of establishments dealing with HIVST, product labelling, advertising and distribution and post-market surveillance and vigilance activities.

Human immunodeficiency virus (HIV) is a retrovirus that targets immune system cells1 (mainly CD4-positive T-cells and macrophages), making an individual more susceptible to various illnesses and infections. It is transmitted through sharing injection equipment or through direct contact with the bodily fluids of an infected individual. It most frequently happens during unprotected sex (sex without using a condom or HIV medication to prevent or treat HIV).

Gazette of the medical devices (compounding of faults) regulations 2024

When receiving any information or complaint that a fault which may be compounded has been done, the Authority may, with permission The Public Prosecutor referred to in sub regulation 2(2), issues an offer to compound the offense in Form 2 of the Second Schedule.

An offer to compound an offense is valid for a period of fourteen days starting from the date the offer is received by person to whom the offer is made or any extended period which may be granted by the Authority, and if full payment of the amount the offer is made on or before the expiry of the fourteen-day period or any such extension of time granted, no further proceedings can be taken against the person who committed the offense.

Medical Device (Exemption) Order 2024

Medical Devices Act 2012 [Act 737], the Minister makes the following order:

1. Exemption from medical device registration
2. Exemption from establishment license
3. Exemption from conformity assessment for Class A medical devices
4. Cancellations and exceptions

Medical device authority (MDA) circular letter no. 1/2024: medical devices imported from or exported to countries with no diplomatic relations with Malaysia subject to trade restrictions

The enforcement of the Circular Letter No. 1/2024, the procedure for registering medical devices imported from/exported to countries without diplomatic relations subject to trade restrictions by Malaysia must go through the following rules:

• The establishment needs to obtain approval to obtain an import license / export license (approved permit – AP) from the relevant agency first as outlined in the Customs Order (Prohibition on Import) and Customs Order (Prohibition on Export). Ownership of the AP will be an additional criterion for the purpose of medical device registration with the MDA; and
• Next, establishments can apply for medical device registration with MDA in accordance with the provisions of Act 737.

Termination of Receiving Bank Draft

Malaysia’s Medical Device Authority (MDA) has informed companies that, effective 1 October, the Ministry of Health will no longer accept payments via bank drafts. This shift aligns with the Ministry’s plan to transition to a fully online payment system. Starting 1 October, MedTech companies must use the Medcast 2.0+ system and the Bayar Now system for payments.  

MEXICO

Mexico joins the highest international forum of medical device regulators

The Federal Commission for the Protection against Health Risks (Cofepris) announces the incorporation of Mexico as an affiliate member of the International Medical Device Regulators Forum (IMDRF).

Mexico’s participation in the forum will allow normative convergence in regulatory matters to facilitate international trade in health supplies and reduce technical barriers in distribution.

Cofepris submits a standard for consultation to guarantee the safety and effectiveness of medical devices

On 26 July, Mexico’s COFEPRIS announced the opening of a comment period on a new scheme for device regulation aimed at adopting internationally used terms and tightening reporting requirements to improve standards. Mexico’s device industry has seen steady growth in recent years, and the draft rule proposes to “allow for the unification of application criteria at a national level harmonized with international guidelines,” according to its preamble. The proposed rule details each regulatory term and acronym and establishes new surveillance protocols for devices. For instance, marketing authorization holders, distributors, and sellers of medical devices would be required to immediately notify Mexico’s health secretary of any adverse events reported to them. The 60-day public comment period will end in late September.

PHILIPPINE

Philippine FDA proposes third delay to medical device deadline to avoid supply disruption

The Philippine Food and Drug Administration (FDA) is planning to delay the deadline for obtaining a Certificate of Medical Device Notification (CMDN) for previously non-registrable Class B, C, and D medical devices.

The agency remains concerned that enforcing the timeline set in March 2023 could disrupt the supply of medical devices in the Philippines. In its latest notice, the agency said it “recognizes the importance of assuring that the availability of medical devices will not be affected” and “understands the need to extend the regulatory flexibility to assist the medical device industry in complying with the regulatory requirements.

Those considerations led FDA to propose allowing Class B, C, and D medical devices to be manufactured, imported, exported, distributed, transferred, sold or offered for sale without a CMDN until 30 September 2024. Under the proposed timeline, companies will have until 30 September to apply for CMDNs.

FDA Circular No.2021-021-A || Extension of the Transitory Provision of FDA Circular No. 2021-021 Entitled “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines” for FDA Licensed Manufacturers, Traders or Distributor (Importers, Exporters and/or Wholesalers) of Medical Devices that Also Sell or Intend to Sell Medical Devices to the General Public

Section IX of FC No. 2021-021 is amended to include the following provisions:

1. The filing of LTO variation application of FDA-licensed manufacturers that sell or intend to sell medical devices directly to the general public pursuant to FC No. 2021-021 is hereby extended until the migration of the online licensing application process from the ePortal System to the eServices Portal System has been completed for the said establishments.

2. Whereas, FDA-licensed traders or distributors of medical devices that sell or intend to sell directly to the general public may apply for variation (additional activity) of their existing LTO through the eServices Portal System (https://eservices.fda.gov.ph/) following the provisions of AO No. 2020-0017, FC No. 2021-021, and FC No. 2021-014 . FDA-licensed traders or distributors are given until June 30, 2024 to secure the approval of the said LTO variation; after which selling of medical devices directly to the general public by the said establishments without securing the amended LTO shall be prohibited.

Reminder on the Submission of Financial Reports in the FDA Online Disclosure Reporting System

Pursuant to Section 35(b) of RA No. 11223 on Ethics in Public Health Policy and Practice, all FDA-licensed manufacturers, traders, relacquers, distributor-importers, and distributor- wholesalers of drug, medical devices, and biological products, including vaccines, and medical supplies registered with the FDA are mandated to collect and track all financial relationships with healthcare providers and healthcare professionals and report these to the Department of Health, through the FDA.

Since the release of Department of Health Administrative Order No. 2021-0036, the FDA has outlined guidelines and established an Online Disclosure Reporting System (ODRS). This system enables stakeholders to conveniently submit all financial relationship disclosure reports.

PORTUGAL

Communication of unavailability of medical devices – implementation of Regulation (EU) 2024/1860 of 13 June 2024

Regulation (EU) 2024/1860 mandates that, from January 10, 2025, medical device and in vitro diagnostic device manufacturers must notify the competent authority of their Member State before any supply interruption or marketing cessation that could pose serious harm or risks to patients or public health.

This obligation lies solely with the manufacturer, whether based inside or outside the EU, though they may seek assistance from authorized representatives, importers, or distributors. Manufacturers must also inform economic operators, healthcare institutions, and professionals directly supplied with the device. Economic operators, in turn, must disseminate this information throughout the supply chain.

Products without a medical purpose in Annex XVI of the Medical Devices Regulation – Amendment of transitional provisions

It is important to add that one of the reasons that led to the review of the transitional provisions was the need to align them with the transitional provisions of the Medical Devices Regulation, which were amended on March 20, 2023 (by virtue of Regulation (EU) 2023/ 607), as the transitional provisions of both regulations refer to products covered by certificates issued by a notified body in accordance with Directive 93/42/EEC (DDM).

In general, the change to the transitional provisions affects the dates until which products for which compliance with the common specifications has not yet been demonstrated, within the six months recommended in the RDM, can be placed on the market or entered into service, and the conditions that apply to products that, currently falling within Annex XVI of the RDM, have been covered by a certificate issued by a notified body under the DDM.

Publication of Decree-Law No. 29/2024, which ensures the implementation, in the Portuguese legal order, of Regulation (EU) 2017/745, relating to medical devices

The diploma establishes, among others, a set of rules applicable to economic operators and health institutions that manufacture and use devices in their respective facilities, as well as rules relating to the use and traceability of devices, the designation and supervision of the activities of notified bodies and market surveillance and inspection.

The diploma also defines the conditions and requirements that the reprocessing and use of reprocessed single-use devices must comply with in national territory, with the aim of establishing the necessary safety and performance conditions of the devices.

https://www.infarmed.pt/web/infarmed/noticias/-/journal_content/56/15786/9921630

Transition period of the European Clinical Trials Regulation No. 536/2014 of 16 April Ends on 30 January 2025

The transition period of the European Clinical Trials Regulation No. 536/2014 of April 16 ends on January 30, 2025. Therefore, if a promoter of clinical trials authorized under Directive No. 2001/20/EC of April 4, and which are expected to take place after January 30, 2025, must act now to transfer them to the Clinical Trials Information System, CTIS.

Publication of Commission Implementing Decision (EU) 2024/2120 on the renewal of the designation of entities issuing unique identifiers (UDI) for Medical Devices

On 30 July 2024, Commission Implementing Decision (EU) 2024/2120 was published, renewing the designation of four entities authorized to operate a UDI (Unique Device Identifier) assignment system for a further five years. The designated entities are GS1, HIBCC, ICCBBA, and IFA. These entities were initially designated under Commission Implementing Decision (EU) 2019/939 after meeting relevant criteria under Regulations (EU) 2017/745 and 2017/746. The renewal followed an assessment confirming their continued compliance with the designation criteria and conditions.

SAUDI ARABIA

Guidance on Biotechnology-based Medical Devices

The guidance has been published in order to clarify regulatory and technical requirements to be taken into consideration during the design and manufacturing stages of biotechnology-based medical devices and its products. In addition, clarifying lists of relevant standards and guidelines, as well as important contact information and links.

SFDA Recognized Standards (Supporting Medical Device Premarket Submissions)

List of ISO Standards for General, Anesthetic, Respiratory, and Ventilators, Transfusion, infusion and injection, and blood processing equipment, Biological Evaluation, Implantable Devices, Surgical Instruments, Sterilization and Disinfectants, In vitro diagnostic, Electro medical are provided in below link.

Guidance for Surgical Sutures

This guidance applies to manufacturers and authorized representatives of surgical sutures with/without needles used for general soft tissue approximation and wound closure/support.The applicant of the surgical sutures marketing authorization shall submit the necessary documents to prove that the surgical sutures to be marketed complies with the essential principles of safety and performance which specified in the Requirements for Medical Device Marketing Authorization (MDS-REQ 1), including proof of compliance with relevant Standards  

The development of IVDs for in-house use

The guidance is to support the creation of design and performance data and documents required to support the development of an in-house IVD, the documentations describe in this guidance are required to be submitted to SFDA upon request.

The Guidance defines and clarifies the requirements of manufacturers of point of care (POC) medical devices. In-house in vitro diagnostic (IH-IVD) medical devices are a subset of POC medical devices. This guidance outlines the development and post market activities for In-house in vitro diagnostic (IH-IVD) medical devices.

Update: Regulations and Requirements for the clearance of medicines, pharmaceutical products, medical devices, and food products that arrive for pilgrims use

The updates in this version are as follows:

• Create a new email to receive application Hajj@sfda.gov.sa
• Change the email to Hajj@sfda.gov.sa
• applications will be received via External Hajj Unified System of the Ministry of Hajj.

Requirements for Clinical Trials of Medical Devices

The document is to specify and clarify the requirements for conducting clinical trials of medical devices within KSA. The document applies to organizations or researchers wishing to conduct clinical investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices within KSA.

Guidance on Innovative Medical Devices

Innovative Medical Devices play a key role in enhancing the quality of life for patients and healthcare providers. To reduce delays in accessing these advanced technologies, the SFDA has introduced a pathway to expedite regulatory processes, ensuring faster access to devices with significant diagnostic, treatment, or monitoring advantages. This guidance outlines the criteria for designating a device as innovative, the review process, and submission requirements under the Innovative Medical Devices Pathway. It is intended for innovators, developers, manufacturers, and authorized representatives seeking Marketing Authorization for such devices.

SFDA Guidance on Content of Labeling of Contact Lenses and its Solutions

The purpose of the guidance document is to define and clarify the contents of the labeling of contact lenses and its solutions that shall be provided within MDMA application and it is applicable to manufacturers and ARs of contact lenses and its solutions.

Notice of promulgation of partial amendment to the Enforcement Rules of the Medical Device Act (Prime Minister Ordinance No. 1946)

The purpose of this rule is to stipulate matters delegated by the Medical Device Act and the Enforcement Decree of the same Act and matters necessary for its implementation. The standards and procedures for classification and designation of medical devices.

Application Procedure for Manufacturing License – A person who wishes to obtain a medical device manufacturing license pursuant to the main text of Article 6 (1) of the Act must submit the following documents (including applications in electronic form) in the attached Form No. 1: (including electronic documents) must be attached and submitted to the Commissioner of the Regional Food and Drug Safety Office having jurisdiction over the location of the manufacturing plant. In this case, if there are two or more manufacturing plants located at different locations, an application may be submitted to the Commissioner of the Regional Food and Drug Safety Office in charge of one of the manufacturing plants.

Announcement of partial amendment to the Enforcement Rules for In Vitro Diagnostic Medical Devices Act 

The revision of the in Vitro Diagnostic Medical Devices Act, effective July 3, 2024, allows institutions other than those designated by the Minister of Food and Drug Safety to participate in clinical performance testing of in vitro diagnostic medical devices. This aims to address deficiencies in the current system by including new standards for managing and supervising clinical performance testing institutions and for disposing of non-compliant device

SINGAPORE

Notice: Singapore’s HSA starts SaMD change management pilot project

Singapore’s Health Sciences Authority (HSA) has introduced a pilot program for an optional regulatory pathway for software as a medical device (SaMD), including machine learning-enabled devices. The program, launched on December 4, 2024, allows companies with strong quality management systems to pre-specify software updates that maintain or improve safety and effectiveness without introducing new risks, bypassing traditional change notification processes. This initiative aims to accommodate the iterative nature of SaMD, streamline regulatory approvals, and support innovation while ensuring safety and performance.

HSA Invites Feedback on Proposed Amendments to Regulation 23 of the Health Products (Therapeutic Products) Regulations

The proposed amendments aim to:

• Provide clarity to industry stakeholders on the types of patents that must be considered when making a registration application for a therapeutic product, and for which the provisions under regulation 23 apply.
• Ensure a system that facilitates all industry stakeholders in making registration applications and minimise any potential indiscriminate use of the mechanism under regulation 23.

GN-15-Revision 11: Guidance on Medical Device Product Registration

The Document describes procedures and general requirements for the submission of an application for a new product registration medical device.

GL-04-Revision 3: Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach

 The document is intended for stakeholders who are involved in software medical device development and /or supplying such devices in Singapore.

The Health Sciences Authority (HSA) is issuing these guidelines to provide clarity on the regulatory requirements for software medical devices in its entire life cycle. The requirements are presented starting from product development, all the way to post- market duties following product introduction in Singapore.

It is important to note that these guidelines reflect HSA’s current thinking and practice, and should not be misconstrued as a new regulatory control on software medical devices.

GN-17 Revision 3: Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN CSDT. In particular, this document serves to provide a summary of the information to be submitted under each section of the ASEAN CSDT. For detailed technical information to be provided under each section of the dossier.

Product registration applications for medical devices submitted to HSA may be prepared in the format set out in the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Device Market Authorisation Table of Contents (nIVD MA ToC).

GN-17 Revision 3: E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS

The document is intended to provide guidance on submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate modules in MEDICS for uploading of the corresponding sections of the CSDT or IMDRF ToC dossier.

Annex 2 for GN-17 and GN18 List of Configurations

List of configurations of medical device to be registered for GN 17 (Guidance on the Common Submission Dossier Template for General Medical Devices) and GN 18 (Guidance on the Common Submission Dossier Template for In Vitro Diagnostic Medical Devices)

GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN CSDT. In particular, this document serves to provide a summary of the information to be submitted under each section of the ASEAN CSDT.

Product registration applications for medical devices submitted to HSA may be prepared in the format set out in the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) In Vitro Diagnostic Device Market Authorisations Table of Contents (IVD MA ToC).

E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3

The document is intended to provide guidance on submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate modules in MEDICS for uploading of the corresponding sections of the CSDT or IMDRF ToC dossier.

TR-01 R3: Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the CSDT and the format that this information is to be submitted in.

TR-02: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for In Vitro Diagnostic (IVD) medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the ASEAN CSDT and the format that this information is to be submitted in.

Revised: Guidance on licensing of Manufacturers, Importers and Wholesalers of Medical devices 

The document provides general guidance on the establishment licensing procedures for medical devices under the Health Products Act. It also outlines the key regulatory responsibilities of individuals and organizations involved in the handling of medical devices in Singapore

SLOVAKIA

Information for submitting applications under the transitional periods of Regulations (EU) 2023/607 MDR and (EU) 2024/1860 IVDR related to the increase in the number of submissions

Due to an increase in applications and longer processing times, the ZP Section recommends the following:

• Do not submit notifications for medical devices (Class I) and in vitro diagnostic devices (Class A) that are not required under Act 362/2011, §110 b, unless they are for categorization at the Ministry of the Interior.
• Do not submit notifications related to the transitional period under Regulation (EU) 2023/607 for medical devices or Regulation 2024/1860 for in vitro diagnostic devices, unless there is a relevant change (e.g., manufacturer change, address change, etc.). Extensions under the transition period alone do not require notification.
• Only submit documents confirming compliance with the transitional period if requested by ŠÚKL.

If it is found that a medical device does not meet the transitional period conditions, ŠÚKL may order the withdrawal of the device from the Slovak market or use until compliance is achieved.

SOUTH KOREA

Notice of promulgation of partial amendment to the Enforcement Rules of the Medical Device Act (Prime Minister Ordinance No. 1946)

The purpose of this rule is to stipulate matters delegated by the Medical Device Act and the Enforcement Decree of the same Act and matters necessary for its implementation. The standards and procedures for classification and designation of medical devices.

Application Procedure for Manufacturing License – A person who wishes to obtain a medical device manufacturing license pursuant to the main text of Article 6 (1) of the Act must submit the following documents (including applications in electronic form) in the attached Form No. 1: (including electronic documents) must be attached and submitted to the Commissioner of the Regional Food and Drug Safety Office having jurisdiction over the location of the manufacturing plant. In this case, if there are two or more manufacturing plants located at different locations, an application may be submitted to the Commissioner of the Regional Food and Drug Safety Office in charge of one of the manufacturing plants.

Announcement of partial amendment to the Enforcement Rules for In Vitro Diagnostic Medical Devices Act 

The revision of the in Vitro Diagnostic Medical Devices Act, effective July 3, 2024, allows institutions other than those designated by the Minister of Food and Drug Safety to participate in clinical performance testing of in vitro diagnostic medical devices. This aims to address deficiencies in the current system by including new standards for managing and supervising clinical performance testing institutions and for disposing of non-compliant device

SPAIN

The AEMPS launches a procedure for consultations related to the qualification and classification of medical devices, including in vitro diagnostic products

The procedure is intended for any natural or legal person who is developing medical devices or for whom the implementation of the regulations for medical devices or in vitro diagnostics involves a change in the qualification and classification of their products. Likewise, it can be used on those products that, due to the implementation of the regulations, fall within the list of products without an intended medical purpose included in Annex XVI of Regulation (EU) 2017/745.

SRILANKA

Informed to the Local agent regarding the email confirmation process for the foreign manufacturing site application

All importers of Medical Devices are hereby informed that NMRA will terminate the email confirmation process for the foreign manufacturing site application (FMSA). Hence, you can submit FMSA application without the email confirmation which is issued by the Head of Medical Device Division/NMRA with effect from 22nd of April 2024.This applies for pending email confirmations as well.

Transferring dossiers to Borderline Products Regulatory Division from other division

All Marketing Authorization Holders (MAHs) of Borderline Products are hereby informed that the Borderline Products Regulatory Division has decided to:

1. Accept transferred applications that have already been submitted to the Medicines Regulatory Division, whether as new applications, re-registrations, or renewals. The remaining balance for the Borderline Products new registration fee should be paid to proceed with the application.
2. Accept transferred applications that have already been submitted to the Medical Devices Regulatory Division:
   • For new applications, payment is not required since the new application fee for Medical Devices is same as the Borderline Products new application fee.
   • For renewal applications, the remaining for the Borderline Products new registration fee balance should be paid to proceed with the application.
3. Accept transferred applications that have already been submitted as cosmetic products, whether as new applications or renewals. Borderline Products new registration fee should be paid to proceed with the application.

SWITZERLAND

Swiss guidelines for validation and Routine monitoring of cleaning and disinfection processes for Medical devices

The guideline is aimed at all healthcare facilities that Preparing medical devices for use on humans, including Dentists, retirement homes, medical practices, podiatry facilities, list not conclusive.

It should be noted that there are medical devices whose processing requires special requirements from the MP manufacturer (e.g. da Vinci, endoeye). The MP manufacturer must provide a description of the processing in accordance with SN EN ISO 17664 can be provided.

Medical devices with certification from the former notified body ECM (Aachen DE, identification number 0481)

ECM1 was a notified body for medical devices. Amongst others, it was authorised to certify high risk devices such as cardiovascular and orthopedic implants. ECM’s notified body status was not renewed by the responsible German authority and expired on 25 May 2020. As of that date, the surveillance of devices certified by ECM in accordance with the requirements of the therapeutic products act was no longer guaranteed.

Swissmedic noticed that medical devices from foreign manufacturers with ECM certificates were still being placed on the Swiss market and therefore decided to inform all Swiss authorised representatives of foreign manufacturers of the matter and their obligations, and to then check compliance with these obligations for a sample.

Swissmedic delays go-live date for swissdamed medical device database

The agreement on mutual recognition of conformity assessments (MRA) between Switzerland and the EU has not been updated, registration of economic operators (CHRN) and of medical devices and in vitro diagnostic medical devices (unique device identification, UDI) is carried out directly by Swissmedic.

Swissmedic structured around two interconnected modules, which only registered users can access. It also includes a freely accessible search function. The individual modules are being made available in stages.

• Registration of companies and economic operators – ACT module (available in the 2nd half of 2024)
• swissdamed – freely accessible platform (available in the 2nd half of 2024)
• Registration of devices – UDI module (available as a minimal viable product (MVP) 4 months after the ACT module goes live)

Information sheet Medical Device Software

The information sheet is intended for manufacturers/developers of medical device software and for economic operators (importers, distributors, authorised representatives) in the distribution chain for such devices.

The first module of the swissdamed medical devices database goes online in August.

The Mutual Recognition Agreement (MRA) with the EU has not been updated, Swissmedic lacks access to the European database EUDAMED3. Consequently, since May 26, 2021, Swiss economic operators (manufacturers, importers, and authorized representatives) must register with Swissmedic to obtain a Swiss Single Registration Number (CHRN). This practice will change when the Actors module for registering economic operators goes live on August 6, 2024.

Applications for CHRN registration, changes, and mandate notifications will be accepted as PDF forms until July 26, 2024. After this date, these forms will no longer be accepted.

EU IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

Swissmedic is enforcing the EU’s recent amendments to the In Vitro Diagnostic Medical Devices Regulation (EU-IVDR) to prevent supply issues in Switzerland during the transitional phase before the Swiss IvDO is amended. The EU adopted Regulation (EU) 2024/1860 on 13 June 2024, extending the validity of certain IVD certificates until 2027-2029 due to bottlenecks at notified bodies. The Swiss Federal Council announced that these amendments would also be implemented in Switzerland. Swissmedic will tolerate the extension of certificates issued under the old EU legislation and will align its enforcement with EU guidelines, with full product registration requirements coming into effect in 2026. Swissmedic remains responsible for market surveillance and may enforce corrective measures to protect public health.

swissdamed – swiss database on medical devices

Swissmedic launched the first module of its new medical devices database, “swissdamed,” on 6 August 2024. The database, which is being rolled out in phases, is designed to register economic operators and medical devices, including in vitro diagnostic devices, on the Swiss market. The first module, “Actors,” allows for the online registration of economic operators. The “Devices” module will be introduced in phases starting in 2025, with mandatory device registration becoming necessary once the database is fully developed and regulations are amended.

swissdamed: All registered economic operators are required to validate their data Deadline on 13 November 2024

In August 2024, all economic operators registered with Swissmedic (CHRN) were asked to validate their data migrated to swissdamed within three months. Nearly 1,000 operators have already completed this. The deadline for validation is 13 November 2024.

The validation process involves two steps: first, checking company data, and second, verifying the data of each registered actor. Detailed instructions must be followed, completing steps 1 to 5 in full. This validation is essential for maintaining data integrity in the Actors module, which supports the smooth implementation of the Devices module and provides an overview of the Swiss medical devices market.

Request to review devices that comply with the old legislation

Swissmedic informs authorized representatives and importers that certificates for legacy medical devices, issued under old legislation, will expire on September 26th, 2024. However, if regulatory requirements are met, these devices may continue to be marketed until 2027 or 2028. The letter highlights transitional provisions and obligations, excluding in vitro diagnostic devices. The notice is sent to all registered representatives and importers and is also published on Swissmedic’s website.

THAILAND

FDA reduces time for requesting permission Emphasis on difficulty and ease according to the risks of medical device products

The FDA has adjusted the system for making changes to facilitate medical device operators through the online system, leaving only 15 business days for hassle-free requests for changes. Not complicated medical equipment Ready to develop work on medical device product supervision and effective consumer protection.

Pharmacist Lertchai Lertwut, Deputy Secretary-General of the Food and Drug Administration, revealed that the Food and Drug Administration (FDA) has opened a channel through the E – submission system to facilitate entrepreneurs applying for minor changes. change which is a type of change that is not difficult or complicated, such as editing the manufacturer of medical equipment, editing the name and address of the product owner, editing the name of the manufacturer in a foreign country without changing the location, etc.

FDA recommends checking for sure in 3 ways before using medical device products

The FDA recommends 3 channels for consumers to check medical device products that have been approved by the FDA by checking the registration number or taking a photo of the product before receiving service. for safety

Deputy Secretary-General of the FDA added that for manufacturers, importers, and sellers of medical devices that are not approved by the FDA, there is a penalty of imprisonment not exceeding 2 years or a fine not exceeding 200, 000 baht, or both. If consumers find suspicious or unauthorized products You can report it at the FDA hotline 1556, P.O.F., Ministry of Public Health, Nonthaburi Province 11004 or Provincial Public Health Offices nationwide.

FDA opens a window to exempt government agencies from requesting permission to manufacture medical devices

FDA opens medical device production channels in government agencies that perform calibration duties to be exempted. There is no need to request permission from the FDA. Just notify according to the specified form. To build confidence for the public that they will receive medical services with standard and efficient tools.

FDA adjusts measures to control COVID-19 test kits, emphasizing consumer safety

The FDA has updated control measures for COVID-19 test kits and reagents to align with the current situation and international standards, aiming to reduce approval time while ensuring public access to safe, high-quality medical devices. Manufacturers and importers can now submit detailed information and evidence without needing a medical device technology assessment. This streamlines the process while maintaining safety and international risk control standards. The changes aim to enhance consumer protection and respond to technological advancements. More details are available on the FDA’s website or via a provided QR code.

FDA reduces approval and licensing procedures, maintaining the safety of medical devices as a top priority

The FDA is reducing steps and requesting documents for medical device approvals, aiming to reduce duplication and maintain effectiveness and safety. The FDA supports the Ministry of Public Health’s policy promoting the health economy industry, facilitating entrepreneurs in developing quality standards. Four announcements have been issued, reducing the burden on entrepreneurs and maintaining the efficiency and safety of medical devices.

UNITED KINGDOM

Guidance on In-house manufacture of medical devices in Great Britain

The guidance applies to healthcare institutions in Great Britain (England, Wales, and Scotland) performing in-house manufacture of medical devices for use within their establishments. It defines healthcare establishments as bodies providing patient care and promoting public health, like NHS hospitals. The document outlines the minimum legal requirements for healthcare institutions performing in-house manufacture of medical devices. Institutions may adopt stricter standards, such as those specified in Northern Ireland’s guidance, provided the minimum requirements in this document are met.

MHRA updates on medical device regulatory reforms

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has outlined its roadmap for reforming medical device regulations through 2026. The plan includes strengthening post market surveillance (PMS) regulations, with legislation expected by January 2025 and enforcement mid-year, alongside guidance publication. Parallel efforts on pre-market requirements involve consultations in 2024, followed by legislative changes by late 2025 and enforcement in 2026. Policy development focuses on early access, innovation, exceptional use authorizations, and refining health institution exemption policies, with key milestones in 2025. Additionally, MHRA is addressing software and artificial intelligence, including guidance for digital mental health technologies, machine learning practices, AI deployment, and cybersecurity, with major deliverables planned for 2025. The reforms aim to enhance regulatory clarity, innovation, and alignment with international standards.

Operational Information Sharing

Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.

Update

Amended to add attachment on how to provide consent for operational information sharing.

Guidance on Regulation of devices in Northern Ireland

The guidance provides general information about regulatory requirements for placing medical devices and IVD devices on the Northern Ireland market only.

The Medical Devices in Vitro Diagnostic Devices etc. Amendment Regulations 2024 came into force on 21 March 2024 and introduce provisions required for implementing the IVDR in Northern Ireland.

Update: Guidance on Borderlines with medical devices and other products in Great Britain

The guidance document only covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended), and therefore does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices. The guidance is specific to products conforming to the UKCA marking requirements unless otherwise stated. The document helps that the product is considered to be a medical device under UK legislation.

Update: Medical devices regulations: compliance and enforcement

The guidance includes information on MHRA’s enforcement duties and how to report a non-compliant medical device. MHRA has the responsibility to check that medical devices in the UK comply with legal requirements.

This guidance includes:

• contact details to report a non-compliant medical device
• information on MHRA’s enforcement duties after receiving a complaint
• MHRA’s routine monitoring role
• the manufacturer’s rights if they have received an enforcement notice

Update: Guidance on Medical devices: UK approved bodies

The guidance provides list of UK approved bodies and types of medical devices for which the approved body is permitted to issue UKCA certification.

Update: Guidance Software and artificial intelligence (AI) as a medical device

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). The guidance provides access to important Software Group outputs that might be of assistance.

Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices.

Guiding Principles On Transparency for Machine Learning-Enabled Medical Devices

The FDA, Health Canada and MHRA have further identified guiding principles for transparency for machine learning-enabled medical devices (MLMDs). These principles build upon the: Good machine learning practice for medical device development (GMLP) principles especially:

principle 7: Focus is placed on the performance of the human-AI team

principle 9: Users are provided clear, essential information

These guiding principles are intended as considerations when adopting and advancing good transparency practices.

Guidance on Export medical devices

The guidance outlines the procedure for ordering a Certificate of Free Sale (CFS) to export medical devices outside the UK.

The MHRA issues Certificates of Free Sale (CFS) only for medical devices registered with them and does not endorse or verify compliance with export requirements. CFS can be ordered exclusively by UK-based manufacturers, UK Responsible Persons, or Northern Ireland-based Authorized Representatives, and requires evidence of relevant conformity marks (UKCA, CE, CE UKNI).

MHRA starts accepting applications for AI Airlock regulatory sandbox pilot

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) is now accepting applications for its AI Airlock regulatory sandbox for medical device developers. This pilot project aims to address challenges in regulating AI medical devices, with the goal of reducing the time needed to bring safe AI devices to patients.

Participants will receive a tailored testing plan and work with regulatory experts to understand the current regulatory framework and data standards. Applicants must demonstrate that their AI-powered device offers potential benefits to patients, is innovative, and presents a suitable regulatory challenge. Applications are open until 7 October, with MHRA seeking diverse candidates across healthcare disciplines and various development stages.