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

On August 4^th 2017, China Food and Drug Administration (CFDA) issued Administrative Measures for Medical Device Clinical Trial Institution Qualification and Filing (exposure draft). According to the draft administrative measures, the proposed date of effectiveness is before the end of 2017. After the Administrative Measures come into force, all the medical device clinical trial institutions located in China should comply with it and file to the provincial medical device authorities and CFDA.

The Background of this Administrative Measures Drafting

The General Qualification for Medical Device Clinical Trial Institution Filing

Qualified medical institution
The medical qualification shall be above level 2A
The medical qualification shall be above level 3A when conduct the class III medical devices that need to be preapproved before clinical trials.
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.
The ethic committee should be complied with the practical requirements of medical device clinical trial quality management (GCP for Medical Device)
The Management System and the SOP of medical device clinical trial would be required.
It has the appropriate treatment subject related to the subject recording and the experts who can undertake medical device clinical trials.
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.
The medical services should meet the requirements of the subjects for the clinical trials of medical devices.
Enable to prevent and handle the emergency and serious adverse events during the clinical trials of medical devices
Other requirements are stipulated by CFDA or NHFPC.

*Please aware that only the medical device clinical trial institutions located in China can apply.

The Procedure of Medical Device Clinical Trial Institution Filing

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

Data Requirements for Medical Device Clinical Trial Institution Filing

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

In China, medical device clinical trial is different from the medicine clinical trials, and there are different GCP and procedure. The initial registered medical devices are required to conduct the clinical evaluation or local clinical trials for medical device registration.

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

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