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Review and approval of medical devices in China: Changes and reform

  • Published:2017-10-28 Issue:6 Volume:106 Page:2093-2100
  • ISSN:1552-4973
  • Container-title:Journal of Biomedical Materials Research Part B: Applied Biomaterials
  • language:en
  • Short-container-title:J. Biomed. Mater. Res.

Author:

Liu Wenbo1,Shi Xinli1,Lu Zhong1,Wang Lanming2,Zhang Kai3,Zhang Xingdong3

Affiliation:

1. Center for Medical Device Evaluation, China Food and Drug Administration; Beijing China

2. Department of Medical Device Registration; China Food and Drug Administration; Beijing , China

3. National Engineering Research Center for Biomaterials; Sichuan University; Chengdu China

Publisher

Wiley

Subject

Biomedical Engineering,Biomaterials

Reference26 articles.

1. The US/China workshop: Regulation, standards, and innovation IV;Zhao;Bioact Mater,2017

2. SFB travels to China for the third China-U.S. joint forum on innovation and regulation of biomaterials;Kuhn;Biomater Forum,2016

3. State Council of the People's Republic of China http://www.sfda.gov.cn/WS01/CL0784/97814.html

4. State Council of the People's Republic of China http://eng.sfda.gov.cn/WS03/CL0767/61641.html

5. http://www.sfda.gov.cn/WS01/CL0053/124222.html

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