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Latest Regulations

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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
Interpretation of the Quality Management Standards for Clinical Trials of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220331-2 Clinical Evaluation 2022-03-31 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the National Medical Products Administration on the Implementation of the Quality Management Standards for Clinical Trials of Medical Devices (No. 21, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第21号 Clinical Evaluation 2022-03-31 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices (No. 30, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第30号 Pre-Market 2022-03-30 2022-03-28
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices (No. 25, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第25号 Pre-Market 2022-03-24 2022-03-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on Issuing Guidelines for Writing Annual Self inspection Reports on Medical Device Quality Management Systems (No. 13, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第13号 Manufacturing 2022-03-24 2022-02-24
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Issuing the Catalogue of Prohibited Commissioned Production of Medical Devices (No. 17, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第17号 Manufacturing 2022-03-24 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice of the National Medical Products Administration on Issuing Guidelines for the Preparation of Quality Agreements for Commissioned Production of Medical Devices (No. 20, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第20号 Manufacturing 2022-03-24 2022-03-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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