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Latest Regulations

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Guiding Principles for Registration Review of Invasive Pressure Sensor Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221209-f2 Registration & Filing 2022-12-09 2022-12-09
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of EEG Machine Products (Draft for Soliciting Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221205-f2 Registration & Filing 2022-12-05 2022-12-05
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Registration and Review of Disposable Epidural Anesthesia Catheters by the Equipment Review Center of the National Medical Products Administration (No. 45, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第45号 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Self testing Blood Glucose Monitoring Systems (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f1 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Gene Mutation Detection Reagents Related to Individualized Tumor Therapy (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f2 Registration & Filing 2022-12-02 2022-12-02
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 Detection Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f3 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Examination of influenza Virus Antigen Testing Reagents (2022 Revision for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f4 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Examination of influenza Virus Nucleic Acid Testing Reagents (2022 revised version for comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f5 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Adhesion Testing Reagents for Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus Antibodies, and G-type Immunoglobulin Antibodies (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f6 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Review of Pathogen Specific M-type Immunoglobulin Qualitative Detection Reagents (Revised Draft for Comments in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20221202-f7 Registration & Filing 2022-12-02 2022-12-02
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
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