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Latest Regulations

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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
Key points for technical evaluation of medical electronic linear accelerators
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f1 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
Key points for technical evaluation of abdominal endoscopic surgery system
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f2 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
Key points for technical evaluation of registration of esophageal stent products
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f3 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
Key points for evaluation of 3D printed intervertebral fusion cage technology
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f4 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
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing Guiding Principles for the Registration and Review of Intravascular Guidewires (No. 11, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第11号 Registration & Filing 2022-03-16 2022-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
Notice on Issuing the Guiding Principles for Stability Research of Passive Implantable Medical Devices (Revised in 2022) by the Equipment Review Center of the National Medical Products Administration (No. 12 of 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第12号 Registration & Filing 2022-03-16 2022-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Guidelines Medical Device
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