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Announcement on Issues Related to Registration and Application of Medical Devices (including In Vitro Diagnostic Reagents)
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2014年第129号 Registration & Filing 2014-11-25 2014-11-25
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 the Classification and Definition of 61 Products, including Automatic Control and Positioning Devices for Endoscopes Used in Laparoscopic Surgery
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]198号 Pre-Market 2014-11-24 2014-11-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Food and Drug Administration on Issuing the Catalogue of Prohibited Commissioned Production of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第18号 Manufacturing 2014-09-26 2014-09-26
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements Medical Device
Notice of the General Office of the State Administration for Food and Drug Administration on the Implementation of the Medical Device Production and Operation License Filing Information System
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2014]476号 Distribution,Manufacturing 2014-09-26 2014-09-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
Notice of the General Office of the Food and Drug Administration on the classification and definition of 34 products including cross-linked and aminated polyvinyl alcohol foam plugging lung volume reduction system
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2014]177号 Pre-Market 2014-09-22 2014-09-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Food and Drug Administration on Issuing Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第16号 Registration & Filing 2014-09-11 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Writing in Vitro Diagnostic Reagent Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第17号 Registration & Filing 2014-09-11 2014-09-11
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on the Implementation of Quality Management Standards for Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2014年第15号 Supervision & Inspection,Manufacturing 2014-09-05 2014-09-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on the Requirements for the Registration and Application of In Vitro Diagnostic Reagents and the Format of Approval Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第44号 Registration & Filing 2014-09-05 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements IVD
Announcement of the State Food and Drug Administration on the Requirements for Publishing Registration and Application Materials for Medical Devices and the Format of Approval Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第43号 Registration & Filing 2014-09-05 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Announcements Medical Device
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