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Latest Regulations

1882  Results

Reply from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]646号 Supervision & Inspection,Distribution 2015-10-22 2015-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD Regulated as Pharmaceuticals
Announcement of the State Food and Drug Administration on Matters Related to Product Registration and Production License for Domestic Medical Device Production Enterprises Opening New Enterprises Across Provinces
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第203号 Manufacturing 2015-10-21 2015-10-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Measures for Quality Supervision and Management of Medical Device Use
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2015年第18号 Usage 2015-10-21 2016-02-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice on Soliciting Opinions on the Guiding Principles for Registration and Application of Particle Beam Therapy Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20151019-2 Registration & Filing 2015-10-19 2015-10-19
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing the Guiding Principles for On site Inspection of Medical Device Operation Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]239号 Supervision & Inspection,Distribution 2015-10-15 2015-10-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Food and Drug Administration on Matters Related to the Production of Disposable Sterile Injection and Infusion Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第71号 Manufacturing 2015-10-12 2015-10-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Guidelines for On site Inspection of Medical Device Production Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f1 Manufacturing 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Guidelines for In Vitro Diagnostic Reagent Field Inspection in Medical Device Production Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f4 Manufacturing,Supervision & Inspection 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Quality Management Standards for Medical Device Production and the Guiding Principles for Aseptic Medical Device Site Inspection
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f2 Manufacturing 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration for Food and Drug Administration on Issuing Four Guiding Principles, including the Guidelines for On site Inspection of Implantable Medical Devices in accordance with the Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]218号-f3 Manufacturing 2015-09-25 2015-09-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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