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Technical Review Points for Clinical Trial Data of Human SDC2 Gene Methylation Detection Reagent
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f1 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Technical evaluation points for clinical trial data of abnormal prothrombin assay reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f2 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Key points for technical evaluation of clinical trial data of Helicobacter pylori 23S rRNA gene mutation detection reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f3 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Key points for technical review of registration of novel coronavirus antigen detection reagent (trial)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第10号-f4 Clinical Evaluation 2022-03-14 2022-03-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
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
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
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
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
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
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