Chinese Regulators Set Procedures for Medical Device Expert Panel Meetings
EMERGO SUMMARY OF KEY POINTS:
- The China Food and Drug Administration (CFDA) has formalized procedures for expert panel meetings to discuss medical device registrations.
- Expert panel meetings are utilized to examine Chinese market authorization applications for innovative or new devices.
- Expert panel meetings may be requested either by CFDA applicants or by the regulator.
Regulators at the China Food and Drug Administration (CFDA) have published formal procedures for expert panel meetings held to discuss medical device registration issues, clarifying the process for Chinese market applicants.
The CFDA standard procedure (link in Chinese) explains scenarios where expert panel meetings may be requested to address questions or concerns from medical device registrants:
- Innovative medical device registrations
- Devices that lack clear working principles
- Devices brand new to the Chinese market
- Devices similar to products already registered with the CFDA, but for which the regulator lacks experience to make approval-related judgments
Expert panel meetings may be requested either by CFDA applicants or by the CFDA’s Center for Medical Device Evaluation (CMDE).
Steps for requesting and arranging an Expert Panel Meeting
According to CFDA procedure, an expert panel meeting is initiated when a regulatory reviewer submits an internal application for a meeting; that request is reviewed and approved by the CMDE.
Following approval, the CFDA will notify the market applicant within 10 days of the meeting approval; any pertinent documents related to the applicant’s registration should be submitted within 20 days of receiving notice of the meeting approval.
Next, CMDE officials will select members of the expert panel, confirm their availability and then notify the applicant within 30 to 40 business days of the meeting details. If the applicant cannot attend the meeting, the expert panel will still convene at that date and time to discuss the device in question.
Following the meeting, the CMDE will complete a technical review within five business days, after which point peer review occurs and final findings are issues to the applicant.
What to expect from a CFDA expert panel meeting
When CFDA applicants begin the expert panel meeting process, they should know that the regulator does not identify experts who will be participating prior to such meetings.
At expert panel meetings, applicants should be prepared to introduce device research and development data, discuss clinical study data, present product samples if available, and answer any questions from attending experts.
Finally, meetings typically last about 40 minutes; 20 minutes are allotted to product design and development, manufacturing processes and product safety and efficacy, and 20 minutes are allotted to clinical study design and findings.
Chinese medical device regulatory support from Emergo:
- CFDA registration support for medical device companies
- CFDA clinical and testing requirements assessment
- China medical device regulatory process chart