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Latest Regulations

1061  Results

Guidelines for Registration and Review of Hepatitis B Virus Deoxyribonucleic Acid Testing Reagents (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f12 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for the Examination and Registration of Intracranial Spring Coils (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231228 Registration & Filing 2023-12-28 2023-12-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Wearable Blood Glucose Measuring Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231227 Registration & Filing 2023-12-27 2023-12-27
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Guidelines for registration and review of invasive blood pressure monitoring products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-1 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for registration and review of invasive pressure sensor products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-2 Registration & Filing 2023-12-25 2023-12-25
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 Non invasive Blood Glucose Monitoring Products (No. 42 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第42号 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Energy Spectrum Imaging Technology for X-ray Computed Tomography Equipment (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-3 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Clinical Trial Registration and Review of Intracranial Thrombolytic Stents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231211-1 Registration & Filing 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of Extracorporeal Membrane Pulmonary Oxygenation Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231211-2 Registration & Filing 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of the Same Variety of Spring Coil Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231211-3 Registration & Filing 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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