1. Expert consultation meeting
Expert consultation meeting refers to the process in which the Center for Medical Device Evaluation of NMPA will invite consultancy experts (hereinafter referred to as “Experts”) to discuss the technical problems to be consulted and offer opinions during its evaluation work for medical device registration.
2. Circumstances in which an expert consultation meeting may be convened
The medical devices that have passed innovation approval.
The medical devices that have passed priority approval.
The medical devices that have passed expedited approval.
The medical devices that are firstly registered among the predicate products.
Technical subcommittees shall respectively resolve the technical problems of other products identified during evaluation. Disputes may be submitted to the Center’s Technical Committee for discussion. When it is necessary to consult experts, the technical subcommittee may apply for convening an expert consultation meeting upon the approval of the Center’s Technical Committee.
3. Relevant process of expert consultation meeting
4. Q&A
Q1. How to select experts？
A1: The experts should be selected from the corresponding expert database by CMDE.
Q2. What could the applicant/registrant do？
A2: If the applicant/registrant is required to attend the expert consultation meeting, the applicant/registrant and R&D experts may participate in the on-site defense.
The applicant/registrant may apply for avoiding the interest-related experts.
The applicant/registrant may apply for evasion date.
Within 10 working days after receiving the notice for expert consultation meeting, the applicant/registrant shall post the return receipt to the Center for Medical Device Evaluation, and submit all electronic documents of registration dossiers at one time within 20 working days thereafter.
5. Tips
The time of expert consultation meeting is not included in the evaluation timeframe.
The time of expert consultation meeting is generally determined by experts and the applicant/registrant through negotiation.
The expert consultation meeting is generally to be convened in the Center for Medical Device Evaluation or the nearby conference rooms.
