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China FDA Changing Medical Device, IVD Submission Requirements

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EMERGO SUMMARY OF KEY POINTS:

  • The China Food and Drug Administration (CFDA) plans to ease certain requirements for registration renewals and clinical trial application processes.
  • CFDA also intends to launch a more robust electronic registration submission system for market applicants.
  • Implementation of these plans would result in less onerous Chinese market entry pathways for foreign device manufacturers.

China CFDA changes to registration renewal, clinical trial rules, plus new electronic submission platformThe China Food and Drug Administration has announced plans to relax some of its medical device and IVD submission requirements as well as develop a system for more comprehensive electronic submissions of Chinese market application materials.

Easing medical device and IVD registration renewals

First, Chinese regulators have proposed (link in Chinese) easing device renewal as well as clinical trial application processes.

CFDA currently requires medical device and IVD registration renewal applicants to provide Product Analysis Reports as part of the renewal process. These reports include data on various topics such as customer and user complaints, adverse event information, global distribution records and post-market surveillance testing.

The regulator plans to remove requirements for Product Analysis Reports; registration renewal applicants will only have to provide reports on follow-up tasks identified in their original device registration certificates.

Home country approval for clinical trials in China

Second, CFDA intends to remove home country approval requirements for clinical trial applicants. Ethics Committee (EC) requirements have also been modified: Requirements that clinical trial sponsors submit EC approval letters from all trial sites will only apply to trials that are not multi-center. For multi-center clinical trials, EC approval letters will be required only from lead sites, not all of them.

Regulated Products Submission System proposal

Finally, CFDA has proposed implementing an online Regulated Product Submission System (link in Chinese) for electronic submission of device registration materials to the regulator. CFDA’s existing electronic submission system only accepts some application documentation, whereas the new system will allow market applicants to upload complete registration dossiers. Furthermore, the new system will enable CFDA reviewers to preview supplementary responses before applicants upload final submissions.

Updates to these proposals and their impact on ease of market entry in China will be provided as we learn them.

Additional Chinese medical device regulatory resources:

 

 

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