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Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第65号 Clinical Evaluation 2021-08-26 2021-08-23
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 Guiding Principles for the Technical Review of Clinical Evaluation of Medical Magnetic Resonance Imaging Systems of the Same Variety (Revised in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第12号 Clinical Evaluation 2021-02-01 2021-01-27
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 Two Registration Technical Review Guiding Principles, including the Clinical Evaluation Technical Review Guidelines for the Same Variety of Imaging Ultrasound Diagnostic Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第2号 Clinical Evaluation 2021-01-18 2021-01-15
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 Two Registration Technical Review Guidelines for Clinical Evaluation of X-ray Computed Tomography Equipment of the Same Variety and Other Two Registration Technical Review Guidelines
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第2号-1 Clinical Evaluation 2021-01-18 2021-01-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Interpretation of the Technical Guidelines for the Clinical Evaluation of Medical Devices Using Real World Data (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20201130-1 Clinical Evaluation 2020-11-30 2020-11-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice of the National Medical Products Administration on the Technical Guidelines for the Release of Real World Data for Clinical Evaluation of Medical Devices (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第77号 Clinical Evaluation 2020-11-25 2020-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Public Solicitation of Comments on the Draft Results Document of the Continued Project "Postmarket Clinical Follow up Study" by the IMDRF Medical Device Clinical Evaluation Working Group
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201021-2 Clinical Evaluation 2020-10-21 2020-10-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on Soliciting Opinions on the New and Revised Catalogue of Medical Devices Exempted from Clinical Trials in 2020 (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200729-1 Clinical Evaluation 2020-07-29 2020-07-29
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice on Publicly Soliciting Opinions on the Guiding Principles of Clinical Evaluation Technology for Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200102 Clinical Evaluation 2020-01-02 2020-01-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Summary of Catalogue of Medical Devices Exempted from Clinical Trials
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20191223 Clinical Evaluation 2019-12-23 2019-12-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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