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Latest Regulations

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Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Medical Device Software Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第50号 Registration & Filing 2015-08-05 2015-08-05
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 Technical Review Guidelines for Hepatitis B Virus Genotyping Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第32号 Registration & Filing 2015-07-15 2015-07-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of New Technology Registration of Imaging Ultrasound Diagnostic Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第33号 Registration & Filing 2015-07-15 2015-07-15
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 Implementing the Policy of Preferential Administrative Fees for Small and Micro Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第31号 Registration & Filing 2015-07-14 2015-07-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement on Adjusting the Method of Receiving Registration Application Materials
Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2015年第150号 Registration & Filing 2015-07-01 2015-07-06
Status Issued By Level of Legal Effect Product Category Valid Administrative Acceptance … Announcements IVD
Announcement of the State Food and Drug Administration on Issuing Fee Standards for Drug and Medical Device Product Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第53号 Registration & Filing 2015-05-27 2015-05-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
Notice on Issuing the Measures for Charging Standards for Registration of Drugs and Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 发改价格[2015]1006号 Registration & Filing 2015-05-12 2015-05-12
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Normative Documents IVD
Key points for animal experimental evaluation of fully degradable coronary artery drug-eluting stents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150423-3 Registration & Filing 2015-04-23 2015-04-23
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Combination Product
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
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