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Latest Regulations

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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
Notice on Adjusting the Work Arrangement for Consultation on Technical Issues Prior to Medical Device Acceptance (No. 37 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第37号 Registration & Filing 2022-10-16 2022-10-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing Guidelines for Checking the Quality Management System of Medical Device Registration (No. 50 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第50号 Registration & Filing 2022-10-10 2022-09-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guidelines for Registration and Review of Zika Virus Nucleic Acid Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f1 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of Brucella IgM/IgG Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f2 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of Hepatitis C Virus Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f3 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Clinical Trial Registration and Review of Non Small Cell Lung Cancer Related Gene Variation Detection Reagents Based on High throughput Sequencing Technology (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f4 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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