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Latest Regulations

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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Implementation Plan for Supporting Hong Kong and Macao Drug Market Licensing Holders to Produce Drugs in 9 Mainland Cities of the Greater Bay Area and the Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in 9 Mainland Cities of the Greater Bay Area
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外〔2022〕63号 Manufacturing 2022-06-29 2022-06-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Clinical Trials of Original Research Accompanying Diagnostic Reagents Developed Simultaneously with Antitumor Drugs (No. 28, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第28号 Registration & Filing 2022-06-28 2022-06-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Clinical Trials of PD-L1 Testing Reagents - Results Reproducibility Studies (No. 27, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第27号 Registration & Filing 2022-06-27 2022-06-27
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Further Strengthening the Service Work of Foreign Funded Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2022〕361号 Registration & Filing 2022-06-27 2022-06-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Guidelines for Technical Review of Affinity Testing Reagents for Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus Antibodies, and G-type Immunoglobulin Antibodies (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f9 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Technical Review of Gene Mutation Detection Reagents Related to Individualized Tumor Therapy (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f8 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Technical Review of Drug Abuse Detection Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f7 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Review of Hepatitis B Virus Deoxyribonucleic Acid Quantitative Testing Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f6 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f10 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guidelines for Registration and Application of Self testing Blood Glucose Monitoring Systems (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f1 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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