Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

Shelf Life for Passive Implantable Medical Devices: Draft Amendment Released

On June 10, 2021, the CMDE (Center for Medical Device Evaluation) of the NMPA (National
Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

UDI Now Proposed for All Class III Medical Devices and IVDs

On July 19, 2021, the NMPA (National Medical Products Administration) published a regulatory draft to
Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

Drug-device combination products in 2021: List of Classification Results for the first batch

On July 7, 2021, the NIFDC (National Institute for Food and Drug Control) issued the
Monday, 26 July 2021 / Published in Medical Device, News, NMPA Registration in China

AI Medical Devices and SaMDs: Classification Guidelines Released

On July 8, 2021, the China NMPA (National Medical Products Administration) announced (No. 47, 2021)