A Road Map To China’s Medical Device Registration Process

China has one of the most promising medical markets and its healthcare industry is currently the second largest in the world, following closely behind the U.S. From 2015 to 2019, the CAGR for the Chinese medical devices market has increased significantly, and it is expected to continue rising even more in the next four years due to the growing population, the escalating prevalence of diseases and disorders, and many other factors.
or overseas manufacturers who are importing their medical devices to China, you will need to obtain a product registration license. For domestic products, both the product registration license and production approval license are mandatory.

A total of three levels are responsible for the management of Chinese medical devices, namely the NMPA, the provincial bureau, and the municipal bureau.

NMPA’s responsibility is:

  • To review and approve registration of class 2 and class 3 imported medical devices.
  • To receive the record of class 1 imported medical devices.
  • To organize the inspection of foreign manufacturers’ QMS.
  • To review and approve domestic class 3 medical devices.

The provincial bureau, such as Zhejiang Medical Products Administration, is responsible for:

  • To review and approve class 2 domestic medical devices.
  • To review and approve domestic manufacturers’ production license for medical devices of class 2 and class 3.

The municipal bureau’s responsibility is:

  • To receive the record of domestic class 1 medical devices.
  • To receive the record of production of domestic manufacturers, which only produce medical devices of class 1.
Author(s)Source
Ng M, Dazhi RMed Device Online 28 April 2021
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