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Latest Regulations

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Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Cardiac Troponin I/Myoglobin/Creatine Kinase Isoenzyme MB Detection Reagents (Colloidal Gold Immunochromatography)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第213号-f2 Registration & Filing 2017-12-22 2017-12-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Examination of Four Registration Technologies, including ABO and RhD Blood Group Antigen Detection Cards (Column Agglutination Method)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第209号-f2 Registration & Filing 2017-12-22 2017-12-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of 5 Registration Technologies, including Luteinizing Hormone Testing Reagents (Colloidal Gold Immunochromatography)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第213号-f1 Registration & Filing 2017-12-22 2017-12-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including the Hepatitis C Virus Nucleic Acid Genotyping Test Kit
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第209号-f4 Registration & Filing 2017-12-22 2017-12-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on Issuing the Guiding Principles for the Examination of Four Registration Technologies, including the Human Epidermal Growth Factor Receptor 2 Gene Amplification Detection Kit (Fluorescence in situ Hybridization Method)
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第209号-f3 Registration & Filing 2017-12-22 2017-12-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Administration on the Issuance of Technical Guidelines for Research and Evaluation of Cell Therapy Products (No. 216 of 2017)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2017年第216号 Registration & Filing 2017-12-22 2017-12-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Fully Automatic Blood Group Analyzers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第209号-f1 Registration & Filing 2017-12-22 2017-12-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Biological Microscopes
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第199号-f2 Registration & Filing 2017-12-12 2017-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Optometers
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第198号-f4 Registration & Filing 2017-12-12 2017-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of 5 Registration Technologies, including Central Monitoring Software
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2017年第198号-f5 Registration & Filing 2017-12-12 2017-12-06
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
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