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Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of 7 Registration Technologies, including Total Bile Acid Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第14号-f7 Registration & Filing 2020-03-05 2020-02-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Circular of the State Administration of Market Supervision, the State Food and Drug Administration, the China National Intellectual Property Administration on Implementing the Ten Articles of Support for Resumption of Production
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第7号 Registration & Filing 2020-02-26 2020-02-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice on the Management Norms for the Requirements of Issuing Supplementary Materials for Medical Device Registration Review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第1号 Registration & Filing 2020-01-16 2020-01-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Two Registration Technologies, including Tumor Related Mutation Gene Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第83号-f1 Registration & Filing 2019-12-05 2019-11-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Two Registration Technologies, including CYP2C19 Drug Metabolizing Enzyme Gene Polymorphism Detection Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第83号-f2 Registration & Filing 2019-12-05 2019-11-12
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Human Chromosome Abnormality Detection Reagents Based on Cell Fluorescence in situ Hybridization
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第80号-f1 Registration & Filing 2019-11-15 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Respiratory Virus Multiple Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第80号-f2 Registration & Filing 2019-11-15 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Nucleic Acid Testing Methods for Staphylococcus aureus and Methicillin Resistant Staphylococcus aureus Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第80号-f3 Registration & Filing 2019-11-15 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Chlamydia trachomatis and/or Neisseria gonorrhoeae Nucleic Acid Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第80号-f4 Registration & Filing 2019-11-15 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Amino Acids, Carnitine, and Succinyl Acetone Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第80号-f5 Registration & Filing 2019-11-15 2019-11-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
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