Medical network on December 30 - 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 spirit, further improve the efficiency of drugs, medical apparatus and instruments for examination and approval of the review, the state food and drug supervision and administration bureau drafted the administration of the state food and drug supervision and administration on the part of the drug administrative examination and approval procedures for examination and approval matters in the decision (draft) "administration of the state food and drug supervision and administration about adjusting part of the decision of the administrative examination and approval procedures for examination and approval matters in the medical devices (draft)". Two copies of the draft has been hanging out in the administration of state food and drug supervision and administration website, until February 6, 2017.
Administration of state food and drug supervision and administration on part of the drug administrative examination and approval procedures for examination and approval matters in the decision
(draft)
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, to further strengthen the drug registration management, 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 drug administrative examination and approval decision, administration of adjustment by state food and drug supervision and administration of drug approval center in the name of the state food and drug supervision and management of administration to make:
A clinical trials, drug examination and approval decision (including domestic and imported);
Second, the drug supplementary application for examination and approval decision (including domestic and imported);
Third, imported drugs registration approval decision again.
Other for drug registration, examination and approval decision according to the program, managed by the state food and drug administration.
After adjusting the examination and approval decision by the state food and drug administration bureau of drug approval, head of the center. 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.
This decision shall enter into force as of March 1, 2017. Related regulations of drug regulatory approval procedures do not agree with this decision, in accordance with this decision.
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
(draft)
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 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.
This decision shall enter into force as of July 1, 2017. Medical device regulatory related regulations of the examination and approval procedures do not agree with this decision, in accordance with this decision. |
