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Latest Regulations

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Notice on Reissuing Administrative Fees for Food and Drug Supervision and Administration Departments under Central Management
Regulation No. Product LifeCycle Issued Date Implemented Date 财税[2015]2号 Clinical Evaluation,Registration & Filing 2015-04-21 2015-04-21
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
Notice of the State Food and Drug Administration on Issuing Technical Review Guidelines for Estrogen Receptor and Progesterone Receptor Antibody Reagents and Detection Kits
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第11号 Registration & Filing 2015-04-17 2015-04-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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
Notice of the General Office of the Food and Drug Administration on the Classification and Definition of 153 Products, including Breast Photography Stereoscopic Positioning Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]49号 Pre-Market 2015-03-31 2015-03-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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
Notice of the General Office of the Food and Drug Administration on Strictly Cracking down on the Illegal Operation of Decorative Colored Flat Light Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2015]48号 Supervision & Inspection 2015-03-30 2015-03-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Administration of Food and Drug Administration on Strengthening the Quality and Safety Management of Condoms
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]30号 Supervision & Inspection 2015-03-23 2015-03-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Announcement of the State Food and Drug Administration on approving the release of 90 medical device industry standards, including YY0572-2015 "Water for Hemodialysis and Related Treatment"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第8号 Product Type Testing 2015-03-02 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … 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
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