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Announcement No. 122 of 2021 on the Requirements for Publishing Registration and Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第122号 Registration & Filing 2021-09-30 2022-01-01

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

Notice of the National Medical Products Administration on the Implementation of the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (No. 76 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第76号 Registration & Filing 2021-09-29 2021-09-28

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

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

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 guidance principles for product comparison instructions included in the list of medical devices exempt from clinical evaluation

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第73号-f5 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 Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (No. 72 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第72号 Clinical Evaluation 2021-09-27 2021-09-16

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

Guiding Principles for Registration and Review of Medical Device Animal Experiment Research Part 1: Decision Principles (Revised in 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告第75号-f1 Registration & Filing 2021-09-27 2021-09-18

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

Guiding Principles for Registration and Review of Medical Device Animal Experiment Research Part 2: Experimental Design and Implementation Quality Assurance

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告第75号-f2 Registration & Filing 2021-09-27 2021-09-18

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

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