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China Extends Trial of Medical Device Registration Regime

A pilot medical device registration system is to be extended to 21 provinces, autonomous regions and municipalities across the mainland. Previously, the system had been trialled in the Shanghai, Guangdong and Tianjin Free Trade Zones.

Overall, the pilot scheme consists of five core elements:

  1. Establishing a management system for the commissioned production of medical devices
  2. Establishing a reliable medical device registrant management system
  3. Prioritising innovation with regard to the oversight of medical devices
  4. Encouraging innovation among medical device manufacturers
  5. Promoting the high-quality development of the medical device industry as a whole

The 21 newly added locations are: Beijing, Tianjin, Hebei, Liaoning, Heilongjiang, Shanghai, Jiangsu, Zhejiang, Anhui, Fujian, Shandong, Henan, Hubei, Hunan, Guangdong, Guangxi, Hainan, Chongqing, Sichuan, Yunnan and Shaanxi.

Details of the eligibility criteria and the obligations of the registrants / commissioned manufacturers participating in the scheme, as well as all relevant procedures, can be found in Circular (Guo Yao Jian Xie Zhu No. 33 [2019]), as issued by the National Medical Products Administration on 1 August this year.

Source: National Medical Products Administration

Content provided by Picture: HKTDC Research
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