CFDA Adjusts the Administrative Examination and Approval Pro

In order to implement the Opinions of the State Council on the Reform of Examination and Approval System for Medicine and Medical Devices (Guo Fa [2015] No. 44) and the reform spirit of relevant administrative examination and approval system of the State Council, to further strengthen the registration management of medical devices and enhance the efficiency of the examination and approval, the State Food and Drug Administration decided that the following administrative examination and approval decisions of medical devices made by the State Food and Drug Administration adjusted to made by the State Food and Drug Administration Medical Devices Review Center in the name of the State Food and Drug Administration the Directorate:

First, the third category of high-risk medical device clinical trial approval decision;

Second, the domestic third category of medical equipment and medical equipment import licensing matters change approval decision;

Third, decisions of the domestic third category of medical devices and Examination and Approval of Continuing Registration of Imported Medical Devices.

According to the current procedures, other approval decisions of medical device registration application will be made by the State Food and Drug Administration.

The director of the State Food and Drug Administration medical device technology review and approval center will be responsible for the issuance of the decision. If the applicant is not satisfied with the conclusion of the examination and approval, he may file an administrative reconsideration with the State Food and Drug Administration or bring an administrative lawsuit.

This Decision will be put into force since 1th July, 2017. If the examination and approval procedures in the relevant regulations on medical device supervision are inconsistent with this decision, they shall be implemented in accordance with this decision.