China FDA Limits Supplementary Notice Consultation Timeframes For Medical Device Registrants
Chinese medical device market regulators have added new rules to limit how often registrants may consult with the agency during preparations to address requests for supplementary information about their market authorization applications.
The new rule (link in Chinese) from the China Food and Drug Administration (CFDA) limits face-to-face consulting times, and requires applicants to make appointments via a new online system.