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Latest Regulations

1220  Results

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
Guiding Principles for Registration and Review of Fibrin Monomer Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f1 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for registration and review of dental root canal lubricant cleaning agents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f27 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Disposable Incision Protective Covers
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f2 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Electroacupuncture Therapy Equipment Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f3 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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