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Key points for clinical evaluation techniques of hip joint prostheses of the same variety

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f7 Clinical Evaluation 2022-03-31 2022-03-31

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Review Key Points Medical Device

Guiding Principles for Technical Review of Clinical Evaluation of Ultrasound Soft Tissue Cutting Hemostatic Systems of the Same Variety

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第93号-f1 Clinical Evaluation 2021-12-13 2021-11-25

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Guiding principles for clinical evaluation, registration, and review of the same variety of dental implant surgery navigation positioning system

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第93号-f2 Clinical Evaluation 2021-12-13 2021-11-25

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Technical Guidelines for Clinical Evaluation Reports of Medical Device Registration and Application

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f4 Clinical Evaluation 2021-09-28 2021-09-18

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Technical Guidelines for Clinical Evaluation of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f1 Clinical Evaluation 2021-09-28 2021-09-18

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Guiding principles for deciding whether to conduct clinical trials of medical devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f2 Clinical Evaluation 2021-09-28 2021-09-18

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Guiding principles for clinical evaluation of medical devices and equivalence demonstration techniques

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f3 Clinical Evaluation 2021-09-28 2021-09-18

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 71 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第71号 Clinical Evaluation 2021-09-18 2021-10-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Clinical Evaluation of Same Variety of Intravascular Catheters (No. 68 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第68号 Clinical Evaluation 2021-09-07 2021-09-02

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device

Interpretation of the Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210827 Clinical Evaluation 2021-08-27 2021-08-27

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD

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