Regulatory

Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2021-03-18 2021-06-01

Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN

Announcement on the Public Solicitation of Opinions on the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NHC-20210316 Clinical Evaluation 2021-03-16 2021-03-16

Status Issued By Level of Legal Effect Product Category Draft National Heath … Work Documents IVD

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the Second Batch of Key Laboratories

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2021〕115号 Clinical Evaluation 2021-03-02 2021-02-26

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

Notice of the National Medical Products Administration on the Recognition of the Second Batch of Key Laboratories

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外函〔2021〕17号 Clinical Evaluation 2021-02-09 2021-02-07

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents 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 the Catalogue of Medical Devices Exempted from Clinical Trials (Second Batch Revision)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第3号 Clinical Evaluation 2021-01-19 2021-01-14

Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN

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

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

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 on Public Solicitation of Comments on the Technical Guidelines for the Use of In Vitro Diagnostic Reagents in Overseas Clinical Trials (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201126-1 Clinical Evaluation 2020-11-26 2020-11-26

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD

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Regulations on the Supervision and Administration of Medical Devices

Announcement on the Public Solicitation of Opinions on the Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings (Draft for Comments)

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the Second Batch of Key Laboratories

Notice of the National Medical Products Administration on the Recognition of the Second Batch of Key Laboratories

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)

Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Trials (Second Batch Revision)

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

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

Interpretation of the Technical Guidelines for the Clinical Evaluation of Medical Devices Using Real World Data (Trial)

Notice on Public Solicitation of Comments on the Technical Guidelines for the Use of In Vitro Diagnostic Reagents in Overseas Clinical Trials (Draft for Comments)