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Guiding Principles for Registration and Review of Quantitative Detection Reagents for Tumor Markers (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f3 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Drug Abuse Testing Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f4 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f5 Pre-Market 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Announcement of the National Medical Products Administration on Issuing the Appendix of the Quality Management Standards for Medical Device Operation: Quality Management of Enterprises Specialized in Providing Medical Device Transportation and Storage Services (No. 94 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第94号 Distribution 2022-11-01 2023-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of Appendix to the Quality Management Specification for Medical Device Operation: Quality Management of Enterprises Specialized in Providing Medical Device Transportation and Storage Services
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221101-2 Distribution 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Medical Device Optical Radiation Safety (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221027 Registration & Filing 2022-10-27 2022-10-27
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the National Medical Products Administration on the Comprehensive Implementation of Electronic Registration Certificates for Medical Devices (No. 91 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第91号 Registration & Filing 2022-10-26 2022-10-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guidelines for Registration Review of Creatine Kinase Testing Reagents (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-28 Registration & Filing 2022-10-25 2022-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement on the Arrangement of On site Consultation Services in the Administrative Acceptance Service Hall of the National Medical Products Administration (No. 316)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第316号 Registration & Filing 2022-10-18 2022-10-18
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements Combination Product
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Immunohistochemical in vitro Diagnostic Reagent Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20221017 Registration & Filing 2022-10-17 2022-10-17
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
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