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Latest Regulations

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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
Guiding Principles for Registration Review of Respiratory Masks (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-13 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 Microscopic Manipulators for Assisted Reproduction (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-14 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 Medical Sodium Hyaluronate Wound Dressings (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-15 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 Electrolyte Analyzers (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-16 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 Glucose Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231025-17 Registration & Filing 2023-10-25 2023-10-24
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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