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Announcement of the National Medical Products Administration on the Release of 21 Medical Device Industry Standards and 1 Amendment Order, including YY/T 0464-2019 "Disposable Hemoperfusion Devices"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第84号 Product Type Testing 2019-11-13 2019-10-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Instructions for Household Medical Devices (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191105 Registration & Filing 2019-11-05 2019-11-05
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of 3D Printing Spinal Fusion Device Product Registration (Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191104-1 Registration & Filing 2019-11-04 2019-11-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Hemodialysis Equipment Registration (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191104-2 Registration & Filing 2019-11-04 2019-11-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Guiding Principles for the Review of Three Registration Technologies, including Embryo Transfer Catheters for Assisted Reproduction
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第78号-f1 Registration & Filing 2019-11-01 2019-10-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing Three Guiding Principles for Registration Technical Review, including Verification and Confirmation of Testing Methods for Known Leachable Substances in Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第78号-f2 Registration & Filing 2019-11-01 2019-10-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Extracorporeal Circulation Pipelines for Cardiopulmonary Bypass Systems
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第78号-f3 Registration & Filing 2019-11-01 2019-10-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Aspartate Aminotransferase Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f1 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Total Cholesterol Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f2 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Uric Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第74号-f3 Registration & Filing 2019-10-29 2019-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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