Medical Devices – USA, Europe, Asia and ROW Regulatory News – May 2024

June 5, 2024 | Medical Device

USA

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.

EUROPE

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 2024-6, 7, 8 and 9 – Preliminary (re-)assessment review form templates

The following are the templates provided in below link:

MDCG 2024-6: Preliminary re-assessment review (PRAR) form template (MDR)
MDCG 2024-7: Preliminary assessment review (PAR) form template (MDR)
MDCG 2024-8: Preliminary assessment review (PAR) form template (IVDR)
MDCG 2024-9: Preliminary re-assessment review (PRAR) form template (IVDR)

Update Link:

https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec14

AUSTRALIA

Update: Guidance on Custom-made medical devices

The guidance provides information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how to regulate them.

Manufacturers and sponsors of custom-made medical devices must:

Notify us of their custom-made medical devices
Follow inspection and review conditions
Maintain records
Supply written statements with their device
Provide an annual report to us, and
Meet our advertising requirements.

Update: Guidance on Evidence requirements for face masks that are medical devices

The guidance provides information on how to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG).

The legal entity responsible for importing and supplying face masks (i.e.: you are the sponsor), must ensure all regulatory requirements relating to the products being supplied are met. All face mask applications for inclusion in the ARTG will be subject to an audit by the TGA and the information and requested documents mentioned in the document.

Update: Guidance on Regulatory requirements for in-house IVDs

The guidance is intended to support Australian laboratories that manufacture in-house IVDs to meet regulatory requirements their in-house IVDs in Australia.

Changes to the previous version

Introduction of the new standardized in-house IVD template for notification of class 1 – 3 In-house IVDs.
Guidance on how to fill the in-house IVD notification template and the notification form.
Further clarification on ongoing responsibilities for in-house IVD manufacturers.
Case studies provided to assist manufacturers of in-house IVDs in Australia on the regulatory requirements.

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.

BRAZIL

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.

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.

CHINA

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.

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

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.

HONG KONG

Guidance Notes: “Overview of the Medical Device Administrative Control System” (GN-01)

The document gives an overview of the MDACS (clause 3). It then goes on to explain in detail the roles of a Local Responsible Person (LRP) within the system (clause 4). Clauses 5, 6, 7 and 8 give further information about the Listing System, including how to apply for the listing of devices, importers, local manufacturers and distributors. Those who are considering to become LRPs are advised to familiarize themselves with the details given in this document.

INDIA

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.

ITALY

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.

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.

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.

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.

MALAYSIA

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.

SRILANKA

Transferring dossiers to Borderline Products Regulatory Division from other divisions

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

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.
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.
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.

THAILAND

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.

UNITED KINGDOM

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: