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Notice on the Key Points for Technical Evaluation of Monkeypox Virus Nucleic Acid Testing Reagents (Trial) issued by the Equipment Review Center of the National Medical Products Administration (No. 31, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第31号 Registration & Filing 2022-07-15 2022-07-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Notice on Issuing Technical Guidelines for Compliance with Basic Principles of Safety and Performance of Medical Devices by the Equipment Review Center of the National Medical Products Administration (No. 29, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第29号 Registration & Filing 2022-07-13 2022-07-12
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements 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
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
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