Insight Blog

Those Efforts in Medical Device Registration Has Been Wasted

On January 9, 2017, the CFDA rejected 7 registration applications, in addition to the 3 other applications rejected on 3rd January, 2017

In accordance to Article 39 of Measures for the Administration of Registration of Medical Device (Decree of CFDA No.4), the following shall not be registered:

  • If the product development carried out by the applicant and its result cannot fully verify the safety and effectiveness of medical device to be sold in the market
  • The registration application contains false documents
  • The registration application documents have confusing or inconsistent contents;



The reject list:


9th January 2017


3rd January 2017

*identities of companies redacted

How did they get through the initial application phase before finally getting rejected?

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