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Latest Regulations

1153  Results

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
Guiding Principles for Registration and Application Materials of Quantitative Detection Reagents for Tumor Markers (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f2 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Application Materials of influenza Virus Antigen Testing Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f3 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Guiding Principles for Registration and Application Materials of influenza Virus Nucleic Acid Testing Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f4 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 Pathogen Specific M-type Immunoglobulin Qualitative Testing Reagents (Revised)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220623-f5 Registration & Filing 2022-06-23 2022-06-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines IVD
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Guidelines for Registration and Examination of Fundus Image Assisted Diagnosis Software for diabetes Retinopathy (No.23 in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第23号 Registration & Filing 2022-06-02 2022-06-02
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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