Medical Devices

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

Contract manufacturing of Hong Kong medical device and drug in GBA is supported by China NMPA's implementation plan announced in June 2022

China medical device clinical evaluation exemption catalogue is released for stakeholder comments. Feedback deadline is August 8, 2022.