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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
Announcement of the National Medical Products Administration on the Release of 7 Medical Device Industry Standards and 1 Amendment Order, including YY0167-2020 Non Absorbable Surgical Sutures
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第21号 Product Type Testing 2020-03-02 2020-02-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Issuing Six Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第18号 Product Type Testing 2020-03-02 2020-02-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements 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 General Office of the National Health Commission on Issuing the First Batch of National Key Management List for High Value Medical Consumables
Regulation No. Product LifeCycle Issued Date Implemented Date 国卫办医函〔2020〕9号 Supervision & Inspection 2020-01-14 2020-01-08
Status Issued By Level of Legal Effect Product Category Valid National Heath … Normative Documents Medical Device
Notice of the Office of Human Genetic Resources Management of China on Simplifying the Approval Process for Some Administrative Approval Projects
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20200107 Clinical Evaluation 2020-01-07 2020-01-02
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents IVD
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