1. The Scope of Consultation after Supplementary
This consultation is mainly for medical device registration items that are in the state of being supplemented. Before the submission of supplementary documents, applicant/registrant can communicate with reviewer about questions of “Deficiency Letter”.
2. Way of consultation
On-site consultation (every Thursday).
Online consultation (online Q&A in 20 working days).
Common questions on CMDE website.
Pre-evaluate for supplementary documents.
3. Reservation for consultation after supplementary
Log in the Technical Review Consulting Platform and click “Ordinary Product Consultation”.
Reserve “On-site Consultation” or “Online Consultation”.
4. The process of Consultation after Supplementary
(1). On-site consultation
The on-site consultation shall be in principle scheduled at 9:00am-11:30am and 13:30pm-16:30pm on each Thursday.
For each medical device after supplementary, applicant/registrant will have three on-site chances to consults at most in principle. One on-site consultation chance will be reduced if applicant/registrant do not use it, and also forget to cancel the reservation.
(2). Online consultation
After receiving online consultation application, reviewers will complete the online Q&A services within 20 working days in principle.
(3). Common questions on CMDE website
Answers for common questions will be published on the CMDE website and official WeChat forth every year in principle.
(4). Pre-evaluation for supplementary documents
CMDE provide pre-evaluation service once for each registration application, including online and offline submission methods.
Applicant/Registrant shall apply for pre-evaluate 2 months ahead of the expiry date of supplementary.
Reviewers will notify the applicant/registrant of the pre-evaluate opinions by email within 20 working days.
The submission of the pre-evaluation of supplementary documents can not be substituted for formal supplementary, and the opinion for pre-evaluation supplementary by the reviewer does not represent a formal confirmation of the supplementary documents.
5. TIPS
Applicants or registrants can apply for on-site consultation reservation on the Consulting Platform of the Center’s website.
