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Latest Regulations

1061  Results

Guidelines for Registration and Review of Hepatitis C Virus Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f3 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Clinical Trial Registration and Review of Non Small Cell Lung Cancer Related Gene Variation Detection Reagents Based on High throughput Sequencing Technology (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f4 Registration & Filing 2022-10-08 2022-10-08
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 Non invasive Blood Glucose/Glucose Monitoring Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220928-4 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for qualitative testing, in vitro diagnostic reagent analysis, performance evaluation, registration and review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f1 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding principles for determining the reference interval of in vitro diagnostic reagents for registration review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f2 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of EB Virus Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f6 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Quality Control Product Registration Review - Research on Quality Control Product Valuation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f3 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for preclinical registration review of human immunodeficiency virus antigen antibody testing reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f5 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Hepatitis E Virus IgM/IgG Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f4 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration Review of Imaging Ultrasound Diagnostic Equipment (Class III) (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-4 Registration & Filing 2022-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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