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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for the Examination and Registration of Intracranial Spring Coils (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231228 Registration & Filing 2023-12-28 2023-12-28
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 Wearable Blood Glucose Measuring Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20231227 Registration & Filing 2023-12-27 2023-12-27
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Industry Standard Management Measures
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2023年第86号 Product Type Testing 2023-12-27 2024-06-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Administrative Regulations Medical Device
Guidelines for registration and review of invasive blood pressure monitoring products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-1 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guidelines for registration and review of invasive pressure sensor products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-2 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Non invasive Blood Glucose Monitoring Products (No. 42 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第42号 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Energy Spectrum Imaging Technology for X-ray Computed Tomography Equipment (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231225-3 Registration & Filing 2023-12-25 2023-12-25
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the State Medical Products Administration, the National Health Commission, and the National Bureau of Disease Control and Prevention on Issuing the Management Regulations for Emergency Use of Medical Devices (Trial) (No. 150 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第150号 Usage 2023-12-15 2023-12-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Administrative Regulations Medical Device
Guidelines for Clinical Trial Registration and Review of Intracranial Thrombolytic Stents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231211-1 Registration & Filing 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of Extracorporeal Membrane Pulmonary Oxygenation Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231211-2 Registration & Filing 2023-12-11 2023-12-11
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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