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Latest Regulations

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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Plan for Strengthening the Quality Supervision of Selected Medical Devices in Centralized Volume Procurement
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2021〕84号 Supervision & Inspection 2021-09-18 2021-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Announcement of the State Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration on Doing a Good Job in the Second Batch of Implementing Unique Identification of Medical Devices (No. 114 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第114号 Pre-Market 2021-09-17 2022-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for the Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Medicinal Device Combination Medical Devices (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20210916 Registration & Filing 2021-09-16 2021-09-16
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Combination Product
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Clinical Evaluation of Same Variety of Intravascular Catheters (No. 68 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2021年第68号 Clinical Evaluation 2021-09-07 2021-09-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Measures for the Administration of Registration and Filing of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2021年第47号 Registration & Filing 2021-08-31 2021-10-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Management Measures for Registration and Filing of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2021年第48号 Registration & Filing 2021-08-31 2021-10-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … UNKNOWN UNKNOWN
Notice of the National Medical Products Administration on Issuing the Implementation Plan for Implementing the State Council's Deepening of the "Separation of Certificates and Licenses" Reform and Further Stimulating the Development Vitality of Market Entities
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210830 Manufacturing,Distribution,Registration & Filing 2021-08-30 2021-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Blood Component Separation and Packaging Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20210830 Pre-Market 2021-08-30 2021-08-30
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Interpretation of the Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20210827 Clinical Evaluation 2021-08-27 2021-08-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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
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