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Latest Regulations

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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
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
Guidelines for Naming Common Names of Physical Therapy Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第26号-f2 Registration & Filing 2022-06-02 2022-05-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … 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 CT Image Assisted Detection Software for Pulmonary Nodules
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第21号 Registration & Filing 2022-05-26 2022-05-26
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Key Points for Technical Review on the Change of Raw Materials of Nitrocellulose Membrane for novel coronavirus (2019 nCoV) Antigen Detection Reagent (Trial) (No. 22 in 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第22号 Registration & Filing 2022-05-26 2022-05-26
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 Review of Extracorporeal Membrane Oxygenation (ECMO) Equipment (No. 19, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第19号 Registration & Filing 2022-04-28 2022-04-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … 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 High Strength and Toughness Pure Titanium Orthopedic Internal Fixation Implants
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第14号 Registration & Filing 2022-04-01 2022-04-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Key points of technical review for evaluation of detection ability of novel coronavirus mutants
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f6 Registration & Filing 2022-03-31 2022-03-31
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points IVD
Key points for technical evaluation of pre filled catheter flushing equipment
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f5 Registration & Filing 2022-03-31 2022-03-31
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
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