Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination and Approval Items of Medical Devices (Decree No. 32 of China Food and Drug Administration)

Issued on April 6, 2017

Decree of China Food and Drug Administration

No.32

The Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination and Approval Items of Medical Devices adopted at the executive meeting of China Food and Drug Administration on February 21, 2017, is hereby promulgated and shall be effective as of July 1, 2017.

Minister: Bi Jingquan

March 20, 2017

Decision of CFDA on Adjusting Approval Procedures for Certain Administrative Examination and Approval Items of Medical Devices

To implement the Opinions of the State Council on Reforming Drug and Medical Device Review and Approval System (G.F. [2015] No.44) and the reform of the State Council on the administrative approval system, further enhance the administration of medical device registration and conscientiously improve the review and approval efficiency, it is decided at the executive meeting of CFDA after deliberation, that the following medical device administrative approval decisions originally made by CFDA shall be adjusted and be made by the Center for Medical Device Evaluation of CFDA on its behalf:

I. Approval decisions on clinical trials for Class III high-risk medical devices;

II. Approval decisions on changes to licensing items for domestic Class III medical devices and imported medical devices;

III. Approval decisions on registration renewal of domestic Class III medical devices and imported medical devices.

Other approval decisions on the registration application of medical devices shall be made by CFDA in accordance with current procedures.

The adjusted approval decisions shall be issued by the head of the Center for Medical Device Evaluation of CFDA. Applicants who disagree with the approval decisions may apply for an administrative reconsideration to CFDA or file for an administrative lawsuit in accordance with law.

Where approval procedures in the relevant medical device supervision provisions are inconsistent with those in this decision, this decision shall prevail.

This decision shall be effective as of July 1, 2017.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.