CFDA Issued Administrative Measures for Medical Device Clinical Trial Institution Qualification and Filing (Exposure Draft)

The Background of this Administrative Measures Drafting

The General Qualification for Medical Device Clinical Trial Institution Filing

1. Qualified medical institution
2. The medical qualification shall be above level 2A
3. The medical qualification shall be above level 3A when conduct the class III medical devices that need to be preapproved before clinical trials.
4. The medical device clinical trial institution would have medical device clinical trial managing department and appropriate administrative staffs, offices and the ability of management and quality control.
5. The ethic committee should be complied with the practical requirements of medical device clinical trial quality management (GCP for Medical Device)
6. The Management System and the SOP of medical device clinical trial would be required.
7. It has the appropriate treatment subject related to the subject recording and the experts who can undertake medical device clinical trials.
8. The PI of medical device clinical trials should have the senior title and more than three times of medical device clinical trial experiences that are consistent with the medical institution’s license.
9. The medical services should meet the requirements of the subjects for the clinical trials of medical devices.
10. Enable to prevent and handle the emergency and serious adverse events during the clinical trials of medical devices
11. Other requirements are stipulated by CFDA or NHFPC.

The Procedure of Medical Device Clinical Trial Institution Filing

1. Medical Device clinical trials institution conducts the self-evaluation and correction.
2. Preparation of the application documents.
3. Filling to the CFDA through the Medical Device Clinical Trials Institution Recording Information System.
4. CFDA reviews the application and issues the Record-keeping.
5. Submit the annual report to CFDA by 31^st Jan.

1. Name, type, address and contact of applicant
2. Level, scale overview of applicant
3. The overview of the subject and PI
4. The main contact of the medical device clinical trials managing department
5. The self-evaluation report
6. The other qualification evidence such as Medical Service License, Medical Institution Level Certificate, and Declaration of Conformity of data.

If you have any more comments about China Medical Device GCP, please contact us at md@cirs-group.com.