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Latest Regulations

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Guiding Principles for Registration Review of Air Oxygen Mixer Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-3 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Laser Positioning System Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-4 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for the registration and review of in vivo electrodes for nerve and muscle stimulators (draft for comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-5 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Traditional Chinese Medicine Pulse Diagnosis Equipment Products (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-6 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Rehabilitation Training Beds (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-7 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Medical Gynecological gel Registration Review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-8 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Technical Review of Registration of Disposable Oxygen Mask Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-9 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Nebulized Mask Products (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-10 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Bronchial Blockers (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-11 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Medical Catheter Fixation Devices (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-12 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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