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 3^rd 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:

9^th January 2017

3^rd January 2017

*identities of companies redacted

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