Administration of state food and drug supervision and administration 

 

No. 32 

 

Administration of the state food and drug supervision and administration on adjusting part of the medical instrument the decision of the administrative examination and approval procedures for examination and approval matters "on February 21, 2017, the state food and drug supervision and management of the administration, adopted at the meeting examined and approved, are hereby released, and effective as of July 1, 2017. 

 

Chief: jingquan 

 

On March 20, 2017 

 

Administration of state food and drug supervision and administration on adjusting part of the decision of the administrative examination and approval procedures for examination and approval matters in the medical devices 

 

To implement the "state council on drug review of medical equipment examination and approval system reform opinions" (guo fa [2015] 44) and the relevant administrative examination and approval system reform, further strengthen the management of medical device registration, review and improve the efficiency of examination and approval, which adopted by the state food and drug supervision and management of the administration research conference, the following by the state food and drug administration bureau of medical apparatus and instruments of administrative examination and approval decision, adjusted by the state food and drug administration of management of medical equipment technical review center in the name of the state food and drug supervision and management of administration to make: 

 

One, the third type of high-risk medical devices clinical trials for examination and approval decision; 

 

Second, domestic class iii medical devices and medical equipment import license change approval decision; 

 

Three, domestic class iii medical devices and imported medical equipment continued to register for examination and approval decision. 

 

Other medical device registration, examination and approval decision according to the program, managed by the state food and drug administration. 

 

After adjusting the administration of examination and approval decision by the state food and drug administration issued by medical instrument technical review center director. If the applicant is not satisfied with the conclusion of examination and approval, can to the administration of state food and drug supervision and administration of administrative reconsideration or institute an administrative lawsuit in accordance with the law. 

 

Medical device regulatory related regulations of the examination and approval procedures do not agree with this decision, in accordance with this decision. 

 

This decision shall enter into force as of July 1, 2017.