EMERGO SUMMARY OF KEY POINTS:

• The China Food and Drug Administration (CFDA) has loosened some requirements in Order No. 43 pertaining to registration renewal and clinical trial application documentation.
• Changes affect analysis reports for renewals as well as home country and ethical committee approvals for clinical trials.

Chinese medical device market regulators have amended requirements for documentation related to registration renewals as well as clinical trial applications to simplify compliance.

First, according to Emergo consultants in Hong Kong, the China Food and Drug Administration’s (CFDA) changes to Order No. 43 (link in Chinese) relaxes some documentation requirements for device registration renewals. Manufacturers no longer must provide analysis reports (which include sales data, post-market inspection and/or testing reports and any complaint, adverse event or recall information) in their renewal applications. Instead, manufacturers only need to include reports on any follow-up activities documented in their original registration certificates.

Second, CFDA has removed requirements that foreign manufacturers provide proof of home country approval in their clinical trial applications. For manufacturers and sponsors running clinical trials at multiple sites, CFDA also no longer requires ethical committee (EC) approvals from all sites; instead, sponsors may now provide EC approvals from only their lead trial sites.

Additional Chinese medical device regulatory resources:

• China CFDA medical device registration consulting
• CFDA clinical and testing requirements assessment
• Whitepaper: CFDA medical device registration requirements
• Regulatory process chart: China medical device approval