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Latest Regulations

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Guidelines for Technical Review of Proton/Carbon Ion Therapy Systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150401 Registration & Filing 2015-04-01 2015-04-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Announcement on Issues Related to the Transitional Period of Application for Continuing Registration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第143号 Registration & Filing 2015-03-31 2015-03-31
Status Issued By Level of Legal Effect Product Category Obsolete Administrative Acceptance … UNKNOWN UNKNOWN
Announcement on Issues Related to Application Materials for Continuing Registration of Medical Devices (including In Vitro Diagnostic Reagents)
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第144号 Registration & Filing 2015-03-31 2015-03-31
Status Issued By Level of Legal Effect Product Category Obsolete Administrative Acceptance … Announcements IVD
Announcement on Relevant Issues Concerning the Acceptance of Medical Electrical Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第137号 Registration & Filing 2015-02-27 2015-02-27
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements Medical Device
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 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
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
Measures for the Administration of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2014年第4号 Registration & Filing 2014-07-30 2014-10-01
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Departmental Rules Medical Device
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