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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 Seven Registration Technologies, including Antithyroid Peroxidase Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第14号-f5 Registration & Filing 2020-03-05 2020-02-21
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 7 Registration Technologies, including Glycosylated Albumin Determination Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第14号-f6 Registration & Filing 2020-03-05 2020-02-21
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 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 Issuing the Key Points for Technical Review of 2019 novel coronavirus Antigen/Antibody Test Reagent Registration (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第6号 Registration & Filing 2020-02-25 2020-02-25
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Issuing the Management Measures for External Experts of Medical Device Technical Evaluation Centers
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200220-1 Registration & Filing 2020-02-20 2020-02-20
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on Issuing the Key Points for Technical Review of 2019 novel coronavirus Nucleic Acid Testing Reagent Registration (No. 4 in 2020)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2020年第4号 Registration & Filing 2020-02-12 2020-02-12
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
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
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