On the issuance of medical device registration review process (Trial) notice

Date：2013-09-16

Provinces, autonomous regions and municipalities Food and Drug Administration ( Drug Administration ) :

In order to strengthen the review of medical device registration approval process review , the National Bureau formulated the "Medical Device Registration Review Program ( Trial ) " , is issued to you , please follow.

Office of the State Food and Drug Administration

二○一○年八月二十六日

Medical Device Registration Review program ( Trial )

In order to strengthen the review of medical device registration approval review work to ensure that the review work in an open, fair, just , improve work efficiency review , the development of this program .

Article 2 The procedure applies to the territory of imported medical devices ( including in vitro diagnostic reagents ) first registration , re-registration , registration certificate change or withdrawal trial shall not be registered ( including not alter ) the decision approving the application for review .

Article applicant food and drug supervision and management departments to review or withdrawal of objection to the decision not to register , you can receive approval from the date of notification of the decision within 20 working days to make a decision approving the Food and Drug Administration department application for review.

Application for review of the matter is limited to the original application and the original dossier .

Article applicant shall submit the application for review the following information :

( A ) by the manufacturer or his agent signed "Medical Device Registration Review Application Form" ( Annex 1 ) ;

( Two ) copies of the original approval notice of the decision .

For foreign medical device registration application for review , such as the application for review made by an agent , the agent should declare the project is the original registered agent.

Article food and drug supervision and management departments accepted the application for review shall, after review and approval in accordance with the original registration procedures, review the project under review.

The first class of medical device registration within a time limit of 15 working days to review ; territory Class II medical device registration time limit of 30 working days to review ; within the third category, foreign medical device registration time limit of 45 working days to review ; Medical Device Registration change reexamination certificate for the 20 days time limit .

Article by reexamination , food and drug supervision and management department decided to maintain the original approval conclusion , it should be issued "Medical Device Registration review decision notice" ( Annex 2 ) ; decided to be corrected in the original approval conclusions , should be directly related to issuance of the license file .

Article VII of food and drug administration department shall make a review of the decision of 10 working days from the date of issuance, delivery review of the decision .

Article review of the decision has been made , food and drug supervision and management departments will no longer accept the applicant 's application for review again .

Article 9 An applicant for food and drug supervision and management departments to review or withdrawal of registration shall not disagree with the decision , and has to apply for administrative reconsideration or bring an administrative lawsuit, food and drug supervision and management departments do not accept its application for review.

Article 10 procedure from the date of promulgation.