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Latest Regulations

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Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Immunohistochemical in vitro Diagnostic Reagent Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20221017 Registration & Filing 2022-10-17 2022-10-17
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines IVD
Notice on Adjusting the Work Arrangement for Consultation on Technical Issues Prior to Medical Device Acceptance (No. 37 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第37号 Registration & Filing 2022-10-16 2022-10-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the National Medical Products Administration on Issuing Guidelines for Checking the Quality Management System of Medical Device Registration (No. 50 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第50号 Registration & Filing 2022-10-10 2022-09-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guidelines for Registration and Review of Zika Virus Nucleic Acid Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f1 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of Brucella IgM/IgG Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f2 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of Hepatitis C Virus Antibody Testing Reagents (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f3 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Clinical Trial Registration and Review of Non Small Cell Lung Cancer Related Gene Variation Detection Reagents Based on High throughput Sequencing Technology (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221008-5-f4 Registration & Filing 2022-10-08 2022-10-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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
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