Chinese FDA Adds to Medical Device Submission Document Requirements
EMERGO SUMMARY OF KEY POINTS:
- Chinese market authorization applicants will have to submit hard and soft copies of their registration applications to regulators, plus declarations of consistency.
- New documentation rules will be effective in November 2016.
The China Food and Drug Administration (CFDA), China’s medical device market regulator, has issued new requirements for what registrants must submit in order to initiate premarket reviews of their products.
According to the CFDA announcement (link in Chinese), Chinese market applicants with Class II and III devices will have to submit not only their original registration dossiers, but also photocopies and soft copies in PDF format, as well as a declaration of consistency attesting that all three submission formats contain the same information.
The new CFDA submission requirements go into effect November 1, 2016.
For additional information on medical device registration and approval in China, download our regulatory process chart.