Medical Devices

CMDE Platform for AI Medical Device in China carried out a closed-door meeting and 17 working groups presented their 2022 3rd quarter reports

China medical device classification results for 388 applications have been announced; Latest catalogue amendment draft proposed 57 changes...

As part of its supervision and administration of medical devices, China undertakes sampling inspections - 12 products failed recently.

China medical device registration review requirements have been updated by the NMPA and have undergone a comprehensive revision.

China medical device registration review guidelines were issued on September 15, 2022, for registrations, renewals, etc. for 27 products.

NMPA medical device standard modifications were issued and came into effect on September 7, 2022, with 92 recommended standards transformed

The medtech, cosmetics and pharmaceutical webinars will cover important China regulatory updates presented by our Cisema regulatory experts.

Hong Kong listing of medical device under some conditions will gain an edge in public procurements carried out by the Department of Health.

The China CAC issued new measures on cross border data transfer for medical devices coming into force on September 1, 2022.

China class I medical device filing, and also IVD reagents, related matters have been clarified by the NMPA on August 12, 2022.

China medical device clinical evaluation terms and definitions are open for industry stakeholders’ comments, also for IVD clinical trials.

China’s NMPA has issued Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices