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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
Key points for technical evaluation of recombinant humanized collagen injection materials for plastic surgery and beauty (trial implementation)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f1 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Key points for technical evaluation of implantable neural stimulators (trial implementation)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f2 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Technical Review Points for Clinical Trial Data of Hepatitis B Virus Pre S1 Antigen Detection Reagent
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f3 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Batteries for Implantable Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221226 Registration & Filing 2022-12-26 2022-12-26
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Invasive Blood Pressure Monitoring Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221209-f1 Registration & Filing 2022-12-09 2022-12-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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