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Latest Regulations

1789  Results

Guiding Principles for Registration and Review of Aspergillus Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f5 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration Review of Self testing Blood Glucose Monitoring Systems (Revised 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f6 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Quantitative Detection Reagents for Tumor Markers (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f8 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Examination of influenza Virus Nucleic Acid Testing Reagents (2023 Revision)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f9 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Examination of influenza Virus Antigen Testing Reagents (2023 Revision)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f10 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Pathogen Specific M-type Immunoglobulin Qualitative Detection Reagents (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f11 Registration & Filing 2024-01-03 2024-01-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
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
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第1号-f7 Pre-Market 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
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