Medical Devices

China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.|China domestic production of imported medical devices policy has been drafted and released by the National Medical Products Administration (NMPA) on November 4 ,2024.

China medical device industry standards were issued by the National Medical Products Administration in July 2024.|China medical device industry standards were issued by the National Medical Products Administration in July 2024.

GBA Connect Scheme has approved 79 medical products—39 pharmaceuticals and 40 devices—benefiting ~10,000 GBA patients as of October 9, 2024.

Hong Kong 2024 Policy Address: Key regulatory updates on medical product approvals and initiatives to enhance biomedical research.

China innovative medical devices special review results have been announced by the NMPA on October 18, 2024.

China NMPA has announced a suspension of import, sale and use of laser surgery equipment manufactured by Jeisys Medical Inc.

Micro-volume syringe priority review application has been announced by the Center for Medical Device Evaluation on October 18, 2024.

Absorbable hemostatic product and other 11 medical devices registration review guidelines have been revised and published by China's CMDE.

The results of China’s latest round of medical device inspection were published by China’s NMPA on 11 September 2024.

InvestHK recently invited Cisema to share regulatory insights at their seminar event, highlighting opportunities in Hong Kong and GBA.

China’s CMDE has published medical device real-world data terms and definitions in draft format for industry comments by October 8, 2024.

China’s NMPA has released a draft Medical Device Administration Law to replace the current China Medical Device Regulations.