China FDA limits supplementary notice consultation timeframes for medical device registrants

By Stewart Eisenhart, Emergo Group

EMERGO SUMMARY OF KEY POINTS:

• The China Food and Drug Administration (CFDA) is introducing new limits on consultations regarding supplementary notices for medical device market applicants.
• Face-to-face CFDA consultation requests must now be submitted through a new online system.
• Online and phone options are available for simpler questions regarding supplementary notices.

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.

Face-to-face CFDA consultation requirements

All appointment dates must be confirmed by CFDA reviewers prior to occurring. The regulator will typically schedule face-to-face consultations only on Thursdays.

All questions applicants wish to cover in such consultations must be provided during appointment requests; both reviewers and applicants must also sign off on all questions at the end of a consultation. Each consultation may last no more than 30 minutes, and take place (theoretically) within 20 business days of an appointment request to the CFDA.

Online CFDA consultation options

For simple questions related to supplementary notice requests, Chinese market registration applicants may go through the CFDA’s online system mentioned above. CFDA reviewers are supposed to answer such questions within 20 business days, except in instances where reviewers require internal peer review before posting answers.

In instances where questions are too complicated, CFDA reviewers will recommend face-to-face consultations instead.

Talking it over

Finally, applicants may call reviewers at the CFDA for simple questions regarding their supplementary notices. The phone option is available Mondays and Wednesdays between 3:30 and 4:30 pm China Standard Time.

Again, CFDA reviewers may recommend face-to-face consultations or online submission of questions in instances where answers are not readily available.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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