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Latest Regulations

1061  Results

Guiding Principles for Registration Review of Breast Implant Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221108-f2 Registration & Filing 2022-11-08 2022-11-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Main Raw Materials for In Vitro Diagnostic Reagents (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f1 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for the Registration and Review of Nucleic Acid Testing and Typing Reagents for Herpes Simplex Virus (HSV) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f2 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Quantitative Detection Reagents for Tumor Markers (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f3 Registration & Filing 2022-11-01 2022-11-01
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Drug Abuse Testing Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221101-f4 Registration & Filing 2022-11-01 2022-11-01
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 Medical Device Optical Radiation Safety (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221027 Registration & Filing 2022-10-27 2022-10-27
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration Review of Creatine Kinase Testing Reagents (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-28 Registration & Filing 2022-10-25 2022-10-24
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 Immunohistochemical in vitro Diagnostic Reagent Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20221017 Registration & Filing 2022-10-17 2022-10-17
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Guidelines for Registration and Review of Zika Virus Nucleic Acid Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f1 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 Registration and Review of Brucella IgM/IgG Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f2 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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