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Latest Regulations

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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Clinical Trials of Medical Devices (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231128 Clinical Evaluation 2023-11-28 2023-11-24
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Administrative Regulations Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Ultrasound Devices for Cosmetic Purposes (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231123 Registration & Filing 2023-11-23 2023-11-23
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Hemodialysis Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231122-1 Registration & Filing 2023-11-22 2023-11-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of X-ray Flat Panel Detection Imaging Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231122-2 Registration & Filing 2023-11-22 2023-11-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Centrifugal Blood Component Separation Equipment (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231122-3 Registration & Filing 2023-11-22 2023-11-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration Review of Disposable Hydrocephalus Diverters (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231115-1 Registration & Filing 2023-11-15 2023-11-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration Review of Absorbable Surgical Sutures (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231115-2 Registration & Filing 2023-11-15 2023-11-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Disposable Intravenous Indwelling Needles (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231115-3 Registration & Filing 2023-11-15 2023-11-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration and Review of Disposable Hemodialysis Tubing (Revised 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231115-4 Registration & Filing 2023-11-15 2023-11-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Review of Hydrogel Dressing Registration (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231115-5 Registration & Filing 2023-11-15 2023-11-15
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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