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Notice of the State Food and Drug Administration on Issuing Four Technical Review Guidelines for Medical Devices, including Allergen Specific IgE Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第93号-f2 Registration & Filing 2015-11-26 2015-11-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Soliciting Opinions on the Guidelines for Writing Instructions for Passive Implantable Bone and Joint Products and Examples of Common Instructions for Passive Implantable Bone and Joint Products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20151120 Registration & Filing 2015-11-12 2015-11-12
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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 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
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
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 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
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