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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Regulations on the Management of Emergency Use of Medical Devices (Trial) (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230119-1 Usage 2023-01-19 2023-01-18
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on Further Clarifying the Registration and Use of Medical Device Master Documents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230118 Registration & Filing 2023-01-18 2023-01-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221230 Manufacturing 2022-12-30 2022-12-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Announcement of the National Medical Products Administration on Issuing the Supervision and Management Regulations for Enterprises to Implement the Main Responsibility of Medical Device Quality and Safety (No. 124 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第124号 Manufacturing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Key points for technical evaluation of recombinant humanized collagen injection materials for plastic surgery and beauty (trial implementation)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f1 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Key points for technical evaluation of implantable neural stimulators (trial implementation)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f2 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Technical Review Points for Clinical Trial Data of Hepatitis B Virus Pre S1 Antigen Detection Reagent
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第47号-f3 Registration & Filing 2022-12-29 2022-12-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Batteries for Implantable Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221226 Registration & Filing 2022-12-26 2022-12-26
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Invasive Blood Pressure Monitoring Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221209-f1 Registration & Filing 2022-12-09 2022-12-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Invasive Pressure Sensor Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221209-f2 Registration & Filing 2022-12-09 2022-12-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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