August 2, 2022
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Medical Devices – Asia Regulatory Updates Roundup, July 2022

India (CDSCO)

CDSCO has issued notice regarding the all non notified medical devices of Class A and Class B devices are scheduled to enter licensing regime with effect from 01 OCT 2022

CDSCO has clarified the rules on medical device quality certificates after identifying “a source of confusion.” The problem relates to entities issuing quality certificates “to the manufacturers at their own level.” In light of the resulting confusion, CDSCO has clarified that quality certificates issued by other entities are not a replacement for licenses granted under the Medical Devices Rules, 2017 by the competent licensing authority. CDSCO issued the clarification ahead of all non-notified Class A and B devices entering the licensing regime at the start of October.

Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD)

CDSCO has proposed Draft Guidance document on Guidance on Post-Market Surveillance of In-vitro Diagnostic Medical Device (IVDMD).

Draft Guidance document on Guidance on Stability Studies of In-Vitro Diagnostic Medical Device (IVDMD)

CDSCO has proposed Draft guidance on stability studies of In vitro diagnostic medical device (IVDMD).

Draft Guidance document on Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD)

The CDSCO has proposed guidance on Performance Evaluation /External Evaluation of In vitro Diagnostic Medical Device (IVDMD).

Classification of Medical Device Pertaining to Rehabilitation under the Provisions of Medical Devices Rules 2017

Check the below link for more information on List of Classification of Medical Devices Pertaining to Rehabilitation.

Classification of Medical Device Pertaining to Obstetrical and Gynecological Under the provision of Medical Devices Rules 2017

The CDSCO has updated the list of Classification of Medical Devices Pertaining to Dental.

CHINA (NMPA)

China approves new domestically developed ‘artificial heart

TIANJIN — China’s National Medical Products Administration has issued marketing approval for a China-developed “artificial heart” for severe heart failure. The “heart” is an implantable ferrofluids-driven left ventricular assist device, according to the TEDA International Cardiovascular Hospital based in north China’s Tianjin Municipality.

Announcement on the release of the recommended path for clinical evaluation of related products in sub-categories 01, 04, 07, 08, 09, 10, 19, and 21 of the “Medical Device Classification Catalog” (No. 30 of 2022)

In order to further guide registration applicants to determine the clinical evaluation path of specific products, the Center for Device Review shall, in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, and the technical guidelines for decision-making on whether to carry out clinical trials of medical devices, etc.

Notice of the Center for Device Review of the State Food and Drug Administration on Issuing Technical Guidelines for the Compliance of the Basic Principles of Medical Device Safety and Performance (No. 29, 2022)

In order to build a scientific medical device supervision system and accelerate the integration with international standards, in March 2020, my country equivalently converted the third edition of IMDRF “Basic Principles of Medical Device Safety and Performance” (hereinafter referred to as “Basic Principles”). The “Basic Principles” are the basic requirements for the safety and effectiveness of medical devices extracted based on general risks.

HONG KONG (MDACS)

Updated Guidance Document Essential Principles of Safety and Performance of Medical Devices.

Medical Device Administrative Control System (MDACS) has updated the guidance document Technical Reference TR-004 (Essential Principles of Safety and Performance of Medical Devices).Guidance document link

SOUTH KOREA (MFDS)

Notification of designation of items subject to examination for approval for export of in vitro diagnostic medical devices

In accordance with Article 3, Paragraph 7 of the Regulations on Permit, Report, Review, etc. of In Vitro Diagnostic Medical Device, items subject to examination for export of in vitro diagnostic medical device are designated and announced as attached. Ministry of Food and Drug Safety Notice No. 2022-346 (2022.7.28.)
Monkey smallpox’ designated as an item subject to examination for approval for export of in vitro diagnostic medical devices

Ministry of Food and Drug Safety shortens medical device software change procedure Timeline

Ministry of Food and Drug Safety shortens medical device software change procedure by 42 days

MALAYSIA (MDA)

FDA Circular No.2017-013-A || AMENDMENT TO FDA CIRCULAR NO. 2017-013, ENTITLED, “GUIDELINES ON THE ISSUANCE OF CLEARANCE FOR CUSTOMS RELEASE (CFCR) OF RADIATION DEVICES BY THE FOOD AND DRUG ADMINISTRATION – CENTER FOR DEVICE REGULATION, RADIATION HEALTH, AND RESEARCH (FDA-CDRRHR)”

The Philippine Food and Drug Administration (FDA) is amending its guidelines on customs release for radiation devices to align the text with an order on the ASEAN harmonized technical requirements.
This Circular shall apply to all importers of radiation devices used for medical and non-medical applications.

AUSTRALIA (TGA)

Guidance on applying the Advertising Code rules

The TGA has published a new guidance on applying the Advertising Code rules that must comply with the 2021 Code rules from 1 July 2022. For more information, please find the link below.

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