Medical Devices

China UDI requirements will cover various class II medical devices manufactured after June 1, 2024, once the regulation comes into effect.

China medical device quality and safety responsibilities have seen new proposals issued by the NMPA recently

China's digital health regulatory framework for SaMD has been evolving with several key legislations implemented over the years by the NMPA.

China medical device registration electronic certificates have the same legal effect as the paper version of the registration certificate.

China IVD Reagent Registration and Review Guidelines have been recently updated. Six guidelines came into effect on September 28, 2022.

China medical electrical equipment will be subject to the new standard GB9706.1 from May 1, 2023, onwards.

Medical device QMS verification guidelines have been updated to assist with the China medical device registration process.

The China medical device mandatory standards list is updated and the CMDE addresses the medical device certificate holders's responsibilities

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.