China medical device QA/RA blog

News and commentary on regulatory changes.

In Brief: New China FDA Guidance on Medical Device Registration Grouping


  • Final guidance from China Food and Drug Administration (CFDA) on medical device registration grouping criteria
  • First CFDA update on registration grouping guidance since March 2015

CFDA updates guidance on medical device registration groupingRegulators at the China Food and Drug Administration (CFDA) have issued final guidance on medical device registration grouping.

The latest CFDA guidance (link in Chinese) follows a draft version published in March 2015. Emergo consultants are currently analyzing the new version to determine any major changes to CFDA registration grouping policies.

We will provide additional updates on the new guidance and its impact on registration grouping criteria as we learn them.

Related CFDA regulatory information from Emergo:

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