In order to further deepen the reform of the review and approval system,Encourage innovation of medical devices,according to Administrative measures for registration and filing of medical devices Order No. of the State Administration of market supervision and Administration47number Administrative measures for registration and filing of in vitro diagnostic reagents Order No. of the State Administration of market supervision and Administration48number Announcement of the State Drug Administration on publishing the requirements for medical device registration application materials and the format of approval certificates 2021Year121number Announcement of the State Drug Administration on publishing the requirements for registration and application materials of in vitro diagnostic reagents and the format of approval certificates 2021Year122number and Implementation of the decision of the State Drug Administration on Administrative measures for registration and filing of medical devices Administrative measures for registration and filing of in vitro diagnostic reagents Notice of relevant matters 2021Year76number Etc,The State Drug Administration shall organize the review of the current Requirements for filing and review of medical device product registration items Trial And other documents have been comprehensively revised.

The medical device technical evaluation center of the State Drug Administration shall review the application materials of the corresponding applications according to the revised filing review requirements at the acceptance link,Completeness of the application materials entering the technical review link Compliance Consistency judgment.Filing review does not affect product safety Rationality of effectiveness evaluation Adequacy analysis,Do not judge the product risk benefit ratio.Filing review is applicable to medical device registration Change of permitted items Clinical trial approval and other application matters.

The revised document is hereby issued,Implemented as of the date of issuance, Issued by the State Food and Drug Administration Requirements for filing and review of medical device product registration items Trial Etc 2019Year42number Repealed at the same time.

It is hereby announced.

enclosure

1.Requirements for filing and review of medical device product registration items

2.Requirements for filing and review of medical device change registration items    

3.Review form for comparison and filing of medical device non clinical evaluation catalogue

4.Medical device clinical evaluation filing review form

5.Review requirements for registration items of in vitro diagnostic reagent products

6.In vitro diagnostic reagent change registration project filing and review requirements

7.Review form for clinical evaluation of in vitro diagnostic reagents Non clinical trial       

8.Review form for clinical evaluation of in vitro diagnostic reagents Clinical trials

9.Requirements for filing and review of approval items for clinical trials of medical devices

10.Requirements for filing and review of medical device renewal registration project

11.Requirements for filing and review of in vitro diagnostic reagent renewal registration project

State Food and Drug Administration

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