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Latest Regulations

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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
Notice of the National Medical Products Administration on the Implementation of the Measures for the Supervision and Administration of Medical Device Production and the Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第18号 Distribution,Manufacturing 2022-03-23 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Measures for the Supervision and Administration of Medical Device Production
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220322-1 Manufacturing 2022-03-22 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Interpretation of the Measures for the Supervision and Administration of Medical Device Operation
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220322-2 Distribution 2022-03-22 2022-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
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