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Guiding Principles for Registration and Review of Quantitative Shear Wave Ultrasound Liver Measurement Instruments (No. 7, 2023) issued by the Equipment Review Center of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230411 Registration & Filing 2023-04-11 2023-04-10
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Ultrasound Soft Tissue Surgical Equipment (Revised in 2023) (No. 4 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第4号 Registration & Filing 2023-03-31 2023-03-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Intraperitoneal Endoscopic Surgery Systems Part 1: Surgical Instruments (No. 5, 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第5号 Registration & Filing 2023-03-23 2023-03-22
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Dental Adhesive Products (No. 3 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第3号-f1 Registration & Filing 2023-03-09 2023-03-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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
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
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