Medical Devices-Asia and ROW Regulatory News – April 2023

ASIA

INDIA (CDSCO)

Circular for Licensing of Class C & D medical devices

According to the Circular It is pertinent to mention that as per Medical Devices rules (MDR) 2017 manufacturing license of class c and D medical devices the inspection needs to be carried out within 60 days from the date of application by the Medical Device Officers (MDO) of central Licensing Authority (CLA), to ensure the compliance with Fifth schedule of MDR 2017.

In order to have smooth transition from mandatory registration to licensing regime, it is suggested that, the manufacturers/importers may apply for grant of manufacturing/import license with all requisite documents and fees as per MDR 2017, through www.cdscomdonline.gov.in portal. The application received will be processed proactively, so that, licensure can be issued within the stipulated time line in order to avoid any disruption of the supply chain of such medical devices and access to the patients.

JAPAN (PMDA)

“Regarding the revision of the medical device defect glossary based on the IMDRF defect glossary”

Reporting of malfunctions, etc. of medical devices (hereinafter referred to as “defect “Reports of Malfunctions, etc. of Medical Devices” (Notification No. 0131 of the Safety of PSEHB dated January31, 2020 by the Director of the Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labor and Welfare).

Regarding the glossary of medical device malfunctions, please refer to “Publication of Medical Device Malfunction Glossary based on IMDRF Malfunction Glossary” (Pharmaceuticals and Medical Devices Agency Medical Device Quality Administration and Safety Department Office Communication), a translated version of “IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes” compiled by the International Medical Device Regulators Forum (IMDRF) (hereinafter referred to as “IMDRF We are pleased to inform you that a glossary of medical device malfunction terms has been compiled based on the “Glossary of Malfunction Terms”. Recently, “Revision of the translation version of the IMDRF glossary of medical devices” (Administrative Notice of the Pharmaceutical Safety Division 

Regarding the revision of the medical device defect glossary based on the IMDRF defect glossary (Incorporated Administrative Agency Pharmaceuticals and Medical Devices Agency Medical Device Quality Control and Safety Department Office Communication dated March 17, 2023) 

System for reporting malfunctions during clinical trials of medical devices (machinery, equipment, etc)

Reports of defects and adverse events during clinical trials of medical devices (hereinafter referred to as “clinical trial defect reports”) are subject to Notification No. 0709004 of the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare dated July 9, 2004. 23 “Regarding Clinical Trials of Medical Devices” of the “Enforcement of the Law for Partial Revision of the Blood Collection.

Blood Donation Agency Control Law” (hereinafter referred to as the “enforcement notice”). Notification No. 0330001 of the PFSB dated March 30, 2010, issued by the Director-General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare, “Regarding reports of clinical trial defects, etc. related to machinery and equipment to the Pharmaceuticals and Medical Devices Agency,” indicates how to handle this.

SaMD Centralized Consultation Desk (Comprehensive Consultation on Medical Device Programs)

In order to promote the early practical application of cutting-edge programmable medical devices (SaMD: Software as a Medical Device), the Ministry of Health, Labor and Welfare and PMDA are conducting SaMD consultations, respectively, as “Medical Device Program Comprehensive Consultation.” We have set up a window to centrally accept.

Applicability of medical device Under the Pharmaceuticals and Medical Devices Act, regulated program medical devices have a purpose as medical devices and may affect the life and health of patients (or users) if they do not function as intended. Programs (software functions) that may cause

PHILIPPINES (FDA)

FDA Circular No.2021-002-C || Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Based on FDA Circular No. 2020-001-A entitled “Amendment to Annex A of FDA Circular No. 2020-001 re: Initial Implementation of Administrative Order NO. 2018-0002 “Guidelines Governing the Issuance of an Authorization for a Medical Device based on the ASEAN Harmonized Technical Requirements”” 

This issuance shall apply to Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001 – A shall be accepted until 31 March 2023; receiving of application for CMDN for these medical devices shall cease starting 1 April 2023; and all manufacturers, traders, exporters, importers, and distributors of the said medical devices shall secure a Certificate of Medical Device Registration (CMDR) starting 1 April 2023.

On 21 April 2022, FC No. 2021-002-B was issued to extend the date wherein all Class B, C and D medical devices that are not included in the list of registrable medical devices based on FC No. 2020-001-A.

In consideration of the challenges brought about by the full implementation of Administrative Order No. 2018-0002, the FDA recognizes that there is a need to provide medical device companies more time to prepare the technical documentary requirements based on the ASEAN common submission dossier template (CSDT) in applying for CMDR.

MALAYSIA (MDA)

Withdrawal of Medical Device Registration (New and Re-Register) And Change Of Notification Application

MDA will withdraw the medical device registration (new and re-register) application and change notification application that has not been completed within 30 working days. However, a transitional period is given to applicant until 1st May 2023 for the full implementation on withdrawal of the medical device registration (new and re-register) application and change notification application.

Submission of medical device registration (new and re-register) and change notification application shall be provided with the information, particulars or document as stated in the Medical Device Act 2012 [Act 737], Medical Device Regulations 2012, guidance documents and guidelines which has been provided on the MDA website (portal.mda.gov.my).

Abortion of Registration Applications (New and Renewal) And Medical Device Amendments

MDA will drop medical device registration applications (new and renewed) and incomplete medical device amendment applications within 30 working days. However, a transition period is given to applicants until May 1, 2023 before the abort process for medical device registration applications (new and re-) and incomplete medical device amendment applications is fully implemented. The submission of medical device registration applications (new and renewed) and medical device amendment applications must be accompanied by information, details or documents as stipulated in the Medical Devices Act 2012 [Act 737], Medical Devices Regulations 2012, circulars MDA, related guidance documents and guidelines that have been placed on the MDA website (portal.mda.gov.my).

Incomplete applications will be returned to the establishment to be completed. The applicant must provide the required information or documents within 30 working days. The application will be dropped if:

1. The establishment does not provide feedback as required within 30 working days; or
2. Applications are returned by establishments without complete documents or information. Accordingly, the establishment needs to check that the information or documents provided are correct and complete before returning them to the MDA

However, dropping this application does not affect the establishment’s right to make a new application. Application fees for dropped applications will not be refunded.

Medical Devices Not Registered on the Market

In order to ensure the safety and security of medical device users in Malaysia, the Medical Device Authority (MDA) continuously carries out market surveillance. Apart from that, MDA also ensures that medical devices available in the Malaysian market are only registered and from licensed sources.

The use of unregistered medical devices is extremely risky because the safety and performance of the medical device cannot be verified. In relation to that, the public and parties involved are encouraged to check the registration status of a medical device first before purchasing. The check can be made by entering the name, brand, or registration number of the device on the label at the link https://mdar.mda.gov.my

CHINA (NMPA)

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the Release of the Guidelines for the Registration and Review of the Laparoscopic Surgical System Part 1: Surgical Devices (No. 5, 2023)

The surgical instrument in this guideline is the end effector of the porous laparoscopic surgical system, which is installed on the robotic arm and controlled by the system to perform invasive surgical tasks. Surgical instruments covered by this guideline include surgical instruments that do not provide energy to patients and high-frequency surgical instruments (excluding vascular closure devices). Refer to the applicable parts of this guideline for the surgical instruments used in the single-port laparoscopic surgery system and other surgical instruments.

This guideline aims to guide registration applicants in the preparation and writing of registration application materials for surgical instruments and high-frequency surgical instruments that do not provide energy to patients (hereinafter referred to as surgical instruments) for laparoscopic surgery systems (hereinafter referred to as surgical systems). At the same time, it also provides a reference for the technical review department to review the registration application materials.

Announcement of the State Food and Drug Administration on Approving the Registration of 290 Medical Device Products (No. 41 of 2023)

The State Food and Drug Administration approved a total of 290 registered medical device products. Among them, there are 227 domestic Class III medical device products, 33 imported Class III medical device products, 26 imported Class II medical device products, and 4 Hong Kong, Macao and Taiwan medical device products.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration review of six medical device products including drug-coated balloon dilatation catheters (No. 9, 2023)

This guideline is applicable to intravascular recovery devices with classification code 03-13-22 in the “Catalogue for Classification of Medical Devices”. For other intravascular retrieval devices, such as vena cava filter retrieval devices, refer to the applicable sections of this guideline.

The drug-coated balloon dilatation catheter involved in this guideline refers to the drug-coated balloon dilation catheter under the classification code 03-13-06 in the “Medical Device Classification Catalog”, and the management category of this product is Class III. For other products under 03-13-06 that do not fall within the scope of this guideline, or have special designs, or the classification code is not classified under 03-13-06, the registration applicant can refer to the guideline applicable content.

The hernia repair patch involved in this guideline refers to the patch products that are implanted in the body to repair hernia or abdominal wall defect and strengthen the weak abdominal wall. The materials include polypropylene/polyester/polytetrafluoroethylene/polyvinylidene fluoride, etc. Non-absorbable synthetic materials, absorbable synthetic materials such as polylactic acid/polycaprolactone, animal-derived materials, allogeneic materials, composite materials, etc.

This guideline is applicable to care products for soft and/or hard contact lenses that have one or more functions such as cleaning, disinfection, rinsing, soaking, preservation, lubrication, etc. At present, it mainly includes contact lens saline solution, detergent, contact lens chemical disinfection products, multi-functional care solution, contact lens lubricant.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of radio frequency cosmetic devices (No. 8, 2023)

The radio frequency beauty equipment mentioned in this guideline refers to the use of specific frequency radio frequency current (usually above 200kHz) or electric field (usually 13.56 or 40.68MHz) and other electrical energy to act on human tissues to generate thermal effects, so as to achieve skin relaxation, relieve Products that wrinkle the skin, shrink pores, tighten/lift skin tissue, or treat acne, blemishes, or fat reduction (fat softening or breakdown). RF aesthetic devices as covered in this guideline include both stand /table-top (large) devices (typically operating on mains power) and hand-held (small) devices (typically operating on internal power).

For products containing both radio frequency energy and other energy (sound, light, etc.), the radio frequency energy part shall be implemented in accordance with the requirements of this guideline. If RF energy and other energies can be output at the same time, the safety and effectiveness of the product should also be considered in combination with the related effects of other energies, and relevant research should be verified under the state of simultaneous energy output.

The guideline does not apply to high-frequency surgical equipment used in the field of plastic surgery. Although this type of product also uses high-frequency current to act on the human body, what it achieves is the effect of cutting and coagulation, which is different from the mechanism of action of radio frequency beauty equipment mentioned in this guideline.

Notice of the Center for Device Evaluation of the State Food and Drug Administration on the release of the guidelines for the registration and review of quantitative shear wave ultrasonic hepatometers (No. 7, 2023)

This guideline is applicable to quantitative shear wave ultrasonic liver measuring instrument, which belongs to 07 ultrasonic physiological parameter measurement and analysis equipment under 07 medical diagnosis and monitoring equipment classification according to the “Medical Device Classification Catalog”. The code is 07-07-02, and the management category of the product is three categories.

This guideline does not include the content of the ultrasonic image part used to confirm the measurement position, which can be declared with reference to the “Guidelines for Technical Review of Image-based Ultrasound Diagnostic Equipment (Class III)”. The “probe” mentioned below refers to the probe used for hardness measurement. If there are corresponding guiding principles for other functions of the product, they shall also comply with the corresponding guiding principles of the product.

Announcement on the release of the 2023 medical device registration review guidelines compilation plan (No. 6, 2023)

The guiding principles of medical device registration review in the registration application and technical review work, our center has organized the drafting of the compilation plan of the guiding principles of medical device registration review (see the attachment for details), which is now released. It is hoped that relevant manufacturers, industry associations, scientific research institutes and other units in the medical device industry will pay attention to the specific notices or solicitation of opinions on the compilation of various guiding principles of our center, and actively participate in the formulation and revision of the guiding principles for medical device registration review.

TAIWAN (TFDA)

Announcement of 112 Annual Medical Device Standards Acceptance List” and “Repealed Previously Accepted Medical Device Standards List

In order to promote the international harmonization of medical device laws and regulations, and assist the industry to follow and refer to them when developing and manufacturing medical devices, the Department continues to promote the approval of medical devices. From 1993 to 110, 11 announcements have been made. Currently A total of 1,081 domestic and foreign medical device standards have been adopted to provide the industry as a reference for R&D and manufacturing of medical devices.

This announcement ” 112 Annual Medical Device Standards Acceptance List” (Appendix 1), a total of 1,156 medical device standards were adopted, including 76 new items, 1 abolished item and 1,079 original approved standards (of which 61 items The standard has been updated).

For the medical device standards adopted in previous announcements, if the original standard version has been abolished, a total of 255 items in the “List of Originally Accepted Medical Device Standards Repealed Over the Years” (Appendix 2) are sorted out. Please adopt the new version or relevant replacement standards as soon as possible.

This case is also published in the announcement area and the special area of medical device regulations of the FDA’s global information website (www.fda.gov.tw).

KYRGYZSTAN (AHWP, EAEU)

To all pharmaceutical companies and manufacturers. SURVEY FOR MEDICAL DEVICES 

Subjects of circulation of medical devices

The State Department of Medicine Provision and Medical Equipment invites stakeholders, manufacturers to take part in a survey on the rules for registration and examination of the safety, quality and effectiveness of medical devices (Decision of the EEC Council No. 46 dated February 12, 2016). The purpose of the survey is to identify and collect possible problems in the process of registration of medical devices that will be launched in the near future. After the analysis of the questionnaires, a meeting-discussion will be organized at the end of May 2023 in order to clarify specific issues.

Completed questionnaires must be sent to the email address osemikg@gmail.com until May 1, 5 of the current year with the note “Questionnaire, organization name”. If any questions, Contact the Department of Medicines and Medical Devices at the Medical Device Registration Office or call 0312 219278.

Regulatory legal acts in the field of regulation of medical devices of the Eurasian Economic Commission are available on the official website of the Eurasian Commission (http://www.eurasiancommission.org/ru/act/texnreg/deptexreg/LSMI/Pages/medical_devices.aspx)

Questionnaire link: http://www.pharm.kg/upload/questionnaire_rus.docx

ROW

SAUDI ARABIA (SFDA)

MDS – G012 Guidance on MDMA – Significant and Non-Significant Changes

The purpose of the document is to clarify the requirements, with examples, of reporting or notifying the SFDA of significant and non-significant changes to marketing authorized medical devices/supplies, referred to in “Executive Regulation of Law of Medical Devices”/article (10-8), and “Requirements for Medical Devices Marketing Authorization (MDS-REQ1)”/Section (5).

Guidelines for manufacturing paths for medical devices and supplies (MDS-G011)

The purpose of the guide is to clarify the paths of manufacturing medical devices and supplies in the Kingdom), trading, distributing and exporting them in the Kingdom, in addition to directing manufacturers to the requirements of the Authority published on its website. This guide applies to local factories for medical devices and supplies.

Transport and Storage Requirements for Medical Devices and Supplies (MDS-REQ 12)

The purpose of the document is to define and clarify transportation and storage requirements for medical devices and supplies. This document applies to the Factories inside the Kingdom. Importers and distributors Warehouses of medical devices and supplies. Providers of medical maintenance services.

Post-marketing control requirements for medical devices and supplies (MDS-REQ11)

The purpose of this document is to define and clarify post-marketing control requirements for medical devices and supplies, which includes the procedures and activities described in the section “Scope of application” below.

Controls and conditions for clearing medicines, pharmaceuticals, devices, medical supplies, and foodstuffs imported for the use of pilgrims

It is an update regarding Customizing an email to receive incoming requests Hajj@sfda.gov.sa Hajj season during Substitution of a letter requesting clearance addressed to the Authority’s office. The General Authority for Food and Drug, by e-mail, to the central office To the following postal address : sa.gov.sfda@Hajj

Ministry of Hajj Clarify that applications will be received via the electronic track

ISREAL (MOH)

Ministry of Health: An administrative extension of validity will be granted to AMR approvals – medical equipment

An automatic extension of validity will be given to AMR approvals for:

• Medical equipment registered in the register of medical accessories and devices maintained by the Ministry of Health and the validity of the AMR approval has expired between 12.1.2022 and 4.30.2024.
• Medical equipment for which registration renewal approval was granted, the expiration date of which is between December 1, 2022 and April 30, 2024.

The new validity of these permits will be until May 31, 2024, without the need to apply to the Ministry of Health, unless the permit has been canceled, or a decision has been made to refuse to renew it. The extension of the validity of the certificates is automatic and there is no need to contact the Ministry of Health in order to extend the registration.

This extension of validity does not apply if there is a change in the medical equipment that requires a submission to change the registration in accordance with the current guidelines, or if the Ministry of Health has ordered the cancellation of the registration of the medical equipment in the register or its suspension.

It is important to emphasize that the Ministry of Health monitors the progress of the European regulatory process, and will update its guidelines accordingly.

URUGUAY (MOPH)

Announcement: -New equipment will allow rapid diagnosis of tuberculosis in Paysandú

The Minister of Public Health, Karina Rando, announced the implementation of a molecular test team in Paysandú that will allow a rapid and more specific diagnosis.
it is announced the implementation of a Genexpert molecular test equipment at the Paysandú Hospital in the coming weeks, to achieve rapid diagnoses and with greater specificity. In this sense, he valued the actions that promote decentralization and speed in actions to attack pathologies.

What is a GeneXpert machine?

The Genexpert diagnoses TB by detecting the presence of TB bacteria. The test is a molecular TB test which detects the DNA in TB bacteria. It uses a sputum sample and can give a result in less than 2 hours.