On March 17, 2020, NMPA issued the 2019 Annual Report for Medical Device Registration, which covers five parts: medical device registration status, medical device registration application acceptance status, medical device registration approval status, innovative medical device registration approval status, and other registration management status. 

• Acceptance of medical device registration applications 

In 2019, NMPA has, as per its powers and duties, accepted a total of 9,104 applications for initial registration, registration renewals, and registration application for amendments of licensing matters of medical devices, a 37.8% increase as compared with that of 2018.

• Medical Device Registration Approval

In 2019, NMPA approved a grand sum of 8,471 registrations applications, up by 53.2% YOY, covering initial registrations (1,726), registration renewals (4,504), and registration alterations (2,241) of medical devices. 

Note: The statistics period of this report is from January 1, 2019 to December 31, 2019.