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Interpretation of "Quality Management Standards for Medical Device Operations" Part 2
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231212 Supervision & Inspection,Distribution 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device
Interpretation of the Quality Management Standards for Medical Device Operations
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231208 Supervision & Inspection,Distribution 2023-12-08 2023-12-08
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device
Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第153号 Supervision & Inspection,Distribution 2023-12-07 2024-07-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of High Frequency Surgical Instruments for Soft Endoscopes (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231206 Registration & Filing 2023-12-06 2023-12-05
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the Comprehensive Department of the National Medical Products Administration on the Classification and Definition of "Degradable Inflatable Hemostatic Sponge" Products
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注函〔2023〕631号 Pre-Market 2023-12-06 2023-12-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Extracorporeal Membrane Oxygen (ECMO) Loop Animal Trials (No. 39 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第39号 Registration & Filing 2023-12-06 2023-12-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of Individualized Drug Genetic Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231206-1 Registration & Filing 2023-12-06 2023-12-06
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of HLA-B27 Genetic Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231206-2 Registration & Filing 2023-12-06 2023-12-06
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Clinical Trial Registration and Review of Colorectal Cancer Related Gene Methylation Detection Kit (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231206-3 Registration & Filing 2023-12-06 2023-12-06
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of ALDH2 Gene Polymorphism Testing Reagents (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231201-1 Registration & Filing 2023-12-01 2023-12-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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