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Latest Regulations

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Guiding Principles for Registration Review of Artificial Shoulder Joint Prostheses (No. 3 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第3号-f2 Registration & Filing 2023-03-09 2023-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Nucleic Acid Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第2号-f1 Registration & Filing 2023-03-02 2023-03-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第2号-f2 Registration & Filing 2023-03-02 2023-03-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Antigen Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第2号-f3 Registration & Filing 2023-03-02 2023-03-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice on Supplementary Explanation on the Implementation of the Ten Related Matters of the Market Supervision Administration, the State Food and Drug Administration, the China National Intellectual Property Administration Supporting the Resumption of Work and Production
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230220 Registration & Filing 2023-02-20 2023-02-20
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Announcement of the National Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration on Doing a Good Job in the Third Batch of Implementing Unique Identification of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第22号 Pre-Market 2023-02-17 2023-02-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Naming Guidelines for Recombinant Collagen Biomaterials
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230129 Pre-Market 2023-01-29 2023-01-29
Status Issued By Level of Legal Effect Product Category Valid Center for … Work Documents Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Regulations on the Management of Emergency Use of Medical Devices (Trial) (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230119-1 Usage 2023-01-19 2023-01-18
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on Further Clarifying the Registration and Use of Medical Device Master Documents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230118 Registration & Filing 2023-01-18 2023-01-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221230 Manufacturing 2022-12-30 2022-12-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
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