China – NMPA reports detail Chinese regulatory activities in 2020

China’s National Medical Products Administration (NMPA) and its Center for Medical Device Evaluation (CMDE) recently published annual reports summarizing regulatory activities in 2020. Both of these reports reflect an active year, with regulatory bodies and medical device manufacturers scrambling to respond to the impact of the COVID-19 pandemic.

CMDE publishes annual report on medical device and IVD registration activities

The CMDE released the 2020 Medical Device Registration Work Report (links in Chinese), which details medical device and IVD registration activities throughout the past year. Out of the 10,579 registration applications accepted (for initial registration, renewal, and technical changes), the NMPA approved 9,849, 16.3% more than were approved in 2019. Notably, 6,246 of the approved applications were for imported medical devices, showing an 18% increase from 2019. Registration activities related to the COVID-19 emergency response and innovative medical devices are also highlighted in the report…