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1153  Results

Guidelines for Clinical Evaluation, Registration and Review of In Vitro Diagnostic Reagents for Tumor Screening (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240122-f1 Registration & Filing 2024-01-22 2024-01-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration Review of PD-L1 Antibody Reagents and Detection Kits (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240122-f2 Registration & Filing 2024-01-22 2024-01-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Monkeypox Virus Nucleic Acid Testing Reagents (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240118 Registration & Filing 2024-01-18 2024-01-18
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Remote Monitoring Systems (No. 5, 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第5号 Registration & Filing 2024-01-18 2024-01-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for Clinical Trial Registration Review of Non Small Cell Lung Cancer Related Gene Variation Detection Reagents Based on High throughput Sequencing Technology
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第4号-f1 Registration & Filing 2024-01-18 2024-01-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Clinical Trial Registration Review of Immunodeficiency Virus like Testing Reagents (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第4号-f2 Registration & Filing 2024-01-18 2024-01-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration Review of Drug Abuse Testing Reagents (Revised 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第4号-f3 Registration & Filing 2024-01-18 2024-01-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for the Registration and Review of Real World Research Design and Statistical Analysis of Medical Devices (No. 3, 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第3号 Registration & Filing 2024-01-15 2024-01-10
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 Peripheral Vascular Stent Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240111 Registration & Filing 2024-01-11 2024-01-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for the registration and review of nucleic acid testing and typing reagents for herpes simplex virus (HSV)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第2号-f1 Registration & Filing 2024-01-04 2024-01-03
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
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