1. Functions of the CMDE
Evaluation of domestic Class III and imported medical devices.
Administrative approval for change of licensing matters and registration renewal of domestic Class III and imported medical devices.
Approval decisions on clinical trials on Class III medical devices with high risks.
2. Registration Application Flowchart
3. Evaluation timeframe
90 working days for Class III medical devices.
60 working days for Class II medical devices.
One year for deficiency submission (excluded from evaluation timeframe).
60 working days for evaluation after response.
4. Query for evaluation and approval The progress of evaluation and approval can be queried via the following routes.
(1). Query on the official website of National Medical Products Administration.
(2).Query on the official website of the Center for Medical Device Evaluation
(3).Query for WeChat official account.
5. The function and contact info of review staff of the CMDE
The official website of the Center for Medical Device Evaluation makes the function and contact info of staff public for further query by applicants.
6. Tips
For the purposes of innovation, priority, emergency and the first and debatable medical device of the same variety, the Center for Evaluation of Medical Devices will, as appropriate, convene an expert consultation meeting during the evaluation.
If the application dossiers do not meet the relevant requirements, the Chief Reviewer will issue a “Deficiency Letter” requiring additional information to the applicant.
