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:
The provincial bureau, such as Zhejiang Medical Products Administration, is responsible for:
The municipal bureau’s responsibility is:
|Ng M, Dazhi R||Med Device Online 28 April 2021|
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