New regulations for Adverse Events Reporting for MD in China
China
On 27 August 2019, the National Medical Products Administration (NMPA) published the Regulations for the Unique Device Identifier (UDI) System for Medical Devices (announced in Circular [2019] No. 66) along with an interpretation. The regulations will enter into force on 1 October 2019, while actual implementation is to take place step-by-step based on risk classifications. More specific information on this step-by-step implementation, however, is still to follow.
The regulations cover the different elements of the UDI-systems, responsibilities of different actors, principles for issuing institutions and relevant requirements for registrants.
GPQI has compiled a policy brief on the regulations outlining its contents and highlighting main changes to previous draft versions. The topic is also part of the Sino-German regulatory dialogue on medical device safety between BMWi and the National Medical Product Administration (NMPA), supported by GPQI China.