Chinese medical device market regulators have enacted a new requirement regarding supplementary documentation requests (links to page in Chinese) related to registration with the China Food and Drug Administration (CFDA).
Effective June 1 2013, medical device registration applicants that receive CFDA requests for supplementary information must comply with the following rules:
- Recipients should submit all supplementary documents at the same time within 60 working days following CFDA requests.
- For supplementary notices issued after May 22 2013, the CFDA will inform recipients of which supplementary information the regulator requires. Again, recipients have 60 working days to comply.
- For recipients of supplementary notices issued before May 22 2013, the CFDA may issue a second supplementary notice if information already submitted does not meet the new requirements.
- In cases where recipients cannot submit requested information within 60 working days, they may submit written applications for extension. The applications should include reasons for extension requests.
- Recipients with questions or disagreements about supplementary notices may contact the CFDA for clarification.
Companies currently undertaking medical device registration in China as well as those firms considering to do so should take note of these new requirements.