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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the draft of the Management Requirements for Temporary Import and Use of Medical Devices in Clinical Urgent Needs of Medical Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231018 Usage 2023-10-18 2023-10-18
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on the Second Public Solicitation of Opinions on the Guiding Principles for the Review of Human Factors Design Registration of Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231011 Registration & Filing 2023-10-11 2023-10-10
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Classification and Definition of in vitro Diagnostic Reagent Products Used in Flow Cytometers (Draft for Comments) and Compilation Explanation
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231011-1 Registration & Filing 2023-10-11 2023-10-11
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Guiding Principles for Classification and Definition of In Vitro Diagnostic Reagents for in situ Hybridization (Draft for Comments) and Compilation Explanation
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231011-2 Registration & Filing 2023-10-11 2023-10-11
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Notice on Soliciting Opinions on the Classification Rules for Medical Devices (Revised Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231010 Pre-Market 2023-10-10 2023-10-10
Status Issued By Level of Legal Effect Product Category Draft Center for … Work Documents Combination Product
Notice on Issuing the Measures for the Review of Science and Technology Ethics (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国科发监〔2023〕167号 Clinical Evaluation 2023-10-08 2023-12-01
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents Medical Device
Guidelines for Registration and Review of Disposable Sterile Side Hole Blunt Needles (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-1 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Absorbable Hemostatic Products (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-2 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
α- Guiding Principles for Registration Review of Cyanoacrylate Medical Adhesives (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-3 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Absorbable Anti Adhesive Products for Abdominal and Pelvic Surgery (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-4 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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