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Opinions of the Comprehensive Department of the National Medical Products Administration on Strengthening the Collaborative Supervision of Cross regional Commissioned Production of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管〔2022〕21号 Manufacturing 2022-04-02 2022-03-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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
Announcement of the National Medical Products Administration and the National Health Commission on Issuing the "Quality Management Standards for Clinical Trials of Medical Devices" (No. 28, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第28号 Clinical Evaluation 2022-03-31 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Key points for clinical evaluation techniques of hip joint prostheses of the same variety
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第13号-f7 Clinical Evaluation 2022-03-31 2022-03-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Review Key Points Medical Device
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