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Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Bone Cement Cannula Components and Other Components
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第107号-f3 Registration & Filing 2018-10-30 2018-10-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Radiofrequency Ablation Endometrial Removal Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181026 Registration & Filing 2018-10-26 2018-10-26
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 the Guiding Principles for Registration and Review of Medical Devices for the Prevention and Treatment of Rare Diseases
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第101号 Pre-Market 2018-10-18 2018-10-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the State Council on Promoting the Reform of "Separation of Certificates and Licenses" Nationwide
Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2018]35号 Manufacturing,Distribution,Registration & Filing 2018-10-10 2018-09-27
Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on 27 Guiding Principles for Technical Review of Registration of Sterilization Processes for Sterile Medical Devices and Other Class II Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20181008-13 Registration & Filing 2018-10-08 2018-10-08
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 Management Guidelines for Management Representatives of Medical Device Manufacturing Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第96号 Supervision & Inspection 2018-09-30 2018-09-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Publishing the Newly Revised Catalogue of Medical Devices Exempted from Clinical Trials
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第94号 Clinical Evaluation 2018-09-30 2018-09-28
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … UNKNOWN UNKNOWN
Announcement of the National Medical Products Administration on approving the release of 15 medical device industry standards, including YY0055-2018 Dental UV Curing Machine
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第72号 Product Type Testing 2018-09-28 2019-04-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on soliciting opinions on the draft guidelines for animal experiments and clinical evaluation of implantable sacral nerve stimulation systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20180927-3 Clinical Evaluation 2018-09-27 2018-09-27
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement of the National Medical Products Administration on the Cleaning Results of Normative Documents for Medical Devices (1998-2013)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2018年第37号 Supervision & Inspection 2018-09-27 2018-09-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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