China Medical Device Registration Annual Report 2019

On March 20, CNstandards investigated and analyzed the regulations, policies and standards issued and implemented by China’s medical device industry in 2019, counted the application, acceptance and approval of class II and class III medical devices, and compared the registration of domestic and imported devices.

I. Laws and policies

  • Regulations on supervision and management of customized medical devices (Trial)
  • 57 guiding principles for technical review of medical devices, including guiding principles for conditional approval of medical devices for listing.
  • The approval procedure for clinical trials of medical devices is adjusted from “express” to “implied”.
  • New and revised list of medical devices exempt from clinical trials
  • The pilot system of medical device registrants expanded to 21 provinces, autonomous regions and municipalities directly under the central government, including Beijing, Jiangsu and Zhejiang.
  • Adjust the attribute definition of the combination of drugs and instruments, and formulate the working procedure of dynamic adjustment of the classification catalogue
  • The electronic declaration of medical device registration (ERPs) is established, and following the online 7512 registration

II. Standard

  • In 2019, the NMPA issued 108 standards development and revision projects, including 15 national standards and 93 industrial standards. 72 industrial standards have been issued. By the end of 2019, there are 1671 current effective standards for medical devices, including 220 National Standards and 1451 industrial standards. The consistency between China’s standards and international standards has reached 90.4%.
  • China took the lead in formulating three guidance documents of clinical evaluation working group of international medical device regulatory body Forum (IMDRF), “clinical evidence – key definitions and concepts”, “clinical evaluation” and “clinical research”

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III. Medical device registration application and acceptance

In 2019, the NMPA accepted 9104 applications for the first registration, renewal registration and change registration of licensing matters of medical devices in accordance with its responsibilities, an increase of 37.8% compared with 2018.

There are 3511 applications for registration of class III medical devices in China and 5593 applications for registration of imported medical devices.

IV. Medical device registration and approval

In 2019, the NMPA Administration approved 8471 first registration, renewal registration and change registration of medical devices, an increase of 53.2% compared with 2018. Among them, 1726 were registered for the first time, 4504 were registered for renewal, and 2241 were changed in licensing matters.

  • 3179 domestic class III medical device registrations were approved
  • 3179 domestic class III medical device registrations were approved
  • 2754 registrations of imported class II medical devices.
  • 2538 registration items of imported class III medical devices.