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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
Notice of the National Medical Products Administration on Issuing Technical Guidelines for Clinical Evaluation of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 74 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第74号 Clinical Evaluation 2021-09-24 2021-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 70, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第70号 Clinical Evaluation 2021-09-18 2021-10-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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
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