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Latest Regulations

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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 Conditional Approval of Medical Device Marketing
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第93号 Registration & Filing 2019-12-20 2019-12-17
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice on Issuing Operating Norms for Expert Consultation Meetings/Expert Public Demonstration Meetings of Medical Device Technology Evaluation Centers
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20191205 Registration & Filing 2019-12-05 2019-12-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents 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 Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法[2019]48号 Manufacturing,Distribution,Registration & Filing 2019-11-29 2019-11-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法[2019]48号 Manufacturing,Distribution,Registration & Filing 2019-11-29 2019-11-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents 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
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