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Latest Regulations

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Management Measures for Compulsory National Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2020年第25号 Product Type Testing 2020-01-06 2020-06-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD
Notice of the State Medical Products Administration on Issuing the Management Measures for Key Laboratories of the State Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外〔2019〕56号 Supervision & Inspection 2020-01-06 2019-12-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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
Interim Measures for the Examination and Management of Advertisements for Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes
Regulation No. Product LifeCycle Issued Date Implemented Date 国家市场监督管理总局令第21号 Supervision & Inspection,Distribution 2019-12-27 2020-03-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing Guidelines for Naming Common Names of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第99号 Pre-Market 2019-12-25 2019-12-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Interim Measures for the Administration of Advertising Review of Drugs, Medical Devices, Health Food, and Formula Food for Special Medical Purposes
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2019年第21号 Supervision & Inspection,Distribution 2019-12-24 2020-03-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD
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
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Conditional Approval of Medical Device Marketing
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第93号 Registration & Filing 2019-12-20 2019-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Publishing the Newly Added and Revised Catalogue of Medical Devices Exempted from Clinical Trials
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第91号 Clinical Evaluation 2019-12-20 2019-12-13
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Announcement of the National Medical Products Administration on the Conversion of 40 Mandatory Medical Device Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance", into Recommended Industry Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第106号 Product Type Testing 2019-12-17 2019-12-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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