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Latest Regulations

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Guiding principles for registration and review of non chronic wound patches
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第35号-f17 Registration & Filing 2022-09-15 2022-09-09
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Quantitative Testing in Vitro Diagnostic Reagent Analysis Performance Evaluation (No. 32 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第32号 Registration & Filing 2022-08-26 2022-08-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines IVD
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Key Points for Technical Review of the novel coronavirus Nucleic Acid Sampling Equipment in the Oropharynx (Trial) (No. 33 in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第33号 Registration & Filing 2022-08-26 2022-08-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Remote Monitoring Systems (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220822 Registration & Filing 2022-08-22 2022-08-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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 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
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