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NMPA Issued the 2019 Annual Report for Medical Device Registration

CCFDIE|Updated: 2020-03-17

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.