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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 Supervision & Inspection,Manufacturing 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
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Registration of Nucleic Acid Testing Reagents for Mycobacterium tuberculosis Composite Group
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第65号 Registration & Filing 2015-09-21 2015-09-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Announcement on Matters Related to the Seals of Clinical Trial Institutions for In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第154号 Clinical Evaluation 2015-09-09 2015-09-09
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements IVD
Notice of the General Office of the Food and Drug Administration on Enabling the Filing Subsystem of the Medical Device Registration Management Information System
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2015]534号 Registration & Filing 2015-09-02 2015-09-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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