The State Drug Administration's notice on issuing documents such as the "Requirements for the Requirement of the Registration Project Registration Project Registration Project of Medical Device Products"

The State Drug Administration's notice on issuing documents such as the "Requirements for the Requirement of the Registration Project Registration Project Registration Project of Medical Device Products"

(No. 40, 2022)

In order to further deepen the reform of the review and approval system and encourage medical device innovation, in accordance with the "Measures for the Registration and File Management of Medical Devices" (Order of the General Administration of Market Supervision and Administration), "Measures for Registration and Recording the Management of Diagnostic Reagents" (National Market Supervision Order of the General Administration of Management), "Announcement on the Requirements and Approval Certificate Formats of the State Drug Administration on the Requirements and Approval Certificate Formats of the State Drug Administration (No. 121, 2021), and" National Drug Administration for announcement of the announcement of in vitro diagnostic reagent reagents registration Announcement of the application information requirements and approval certification documents (No. 122, 2021) and the "National Drug Administration Administration's" Measures for the Management Measures for Medical Device Registration and Records " "(2021 No. 76) and other relevant requirements, the State Drug Administration organized a comprehensive revision of the current documents such as the" Requirement Requirement Requirement Requirements (Trial) "and other documents such as the" Registration of Medical Device Products (Trial) ".

The National Pharmaceutical Supervision and Administration Medical Devices Technology Review Center reviews the corresponding application materials for the application information in accordance with the revised volume review requirements, and the integrity, compliance, and consistency of the application information entering the technical review link judge. The stand -up review does not analyze the rationality and adequacy of product safety and effective evaluation, and does not judge the product risk benefit ratio. The stand -up review is applicable to applications such as medical device registration, license change, and clinical trial approval.

The revised documents are now published, and from the date of release, the "Notice of the State Drug Administration on the release of the" Requirement Review Requirements (Trial) "(Trial) and other documents (2019 No. 42) at the same time Remove.

announce.

appendix:

1. Medical Device Product Registration Project Registration Review Review Requirements

2. Medical Device Change Registration Project Registration Review Review Requirements

3. Medical Device Revolutionary Clinical Evaluation Catalog Comparison Paper Examination Form

4. Clinical Evaluation Form for Medical Devices

5. In vitro diagnostic reagent product registration project registration requirements

6. In vitro diagnostic reagent change registered project registration requirements

7. Clinical evaluation of in vitro diagnostic reagents (non -clinical trials)

8. Clinical evaluation of in vitro diagnostic reagents (clinical trials)

9. Requirement requirements for clinical trial approval projects for medical device clinical trials

10. Medical Device Continuing Registration Project Registration Review Review Requirements

11. In vitro diagnostic reagent continuing registered projects for registration projects

State Drug Administration

August 26, 2022

appendix

appendix:

1. Medical Device Product Registration Project Registration Review Review Requirements

2. Medical Device Change Registration Project Registration Review Review Requirements

3. Medical Device Revolutionary Clinical Evaluation Catalog Comparison Paper Examination Form

4. Clinical Evaluation Form for Medical Devices

5. In vitro diagnostic reagent product registration project registration requirements

6. In vitro diagnostic reagent change registered project registration requirements

7. Clinical evaluation of in vitro diagnostic reagents (non -clinical trials)

8. Clinical evaluation of in vitro diagnostic reagents (clinical trials)

9. Requirement requirements for clinical trial approval projects for medical device clinical trials

10. Medical Device Continuing Registration Project Registration Review Review Requirements

11. In vitro diagnostic reagent continuing registered projects for registration projects

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