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Latest Regulations

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Announcement of the National Medical Products Administration on Delaying the Payment of Registration Fees for Drugs and Medical Devices (No. 81 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第81号 Registration & Filing 2022-09-29 2022-09-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Non invasive Blood Glucose/Glucose Monitoring Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220928-4 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for qualitative testing, in vitro diagnostic reagent analysis, performance evaluation, registration and review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f1 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding principles for determining the reference interval of in vitro diagnostic reagents for registration review
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f2 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of EB Virus Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f6 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Quality Control Product Registration Review - Research on Quality Control Product Valuation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f3 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for preclinical registration review of human immunodeficiency virus antigen antibody testing reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f5 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Hepatitis E Virus IgM/IgG Antibody Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第36号-f4 Registration & Filing 2022-09-28 2022-09-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Guidelines for Registration Review of Imaging Ultrasound Diagnostic Equipment (Class III) (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-4 Registration & Filing 2022-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Fibrin Monomer Assay Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f1 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
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