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Notice on Issuing Clinical Evaluation Recommended Pathways for Related Products in Subcategories 11, 12, 13, 14, 15, 17, and 22 of the Classification Catalogue of Medical Devices (No. 20, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第20号 Clinical Evaluation 2022-05-19 2022-05-19
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Notice on Issuing the Communication and Exchange Procedure for Clinical Real World Data Application Pilot Varieties of Medical Devices in Hainan Boao Lecheng International Medical Tourism Pilot Zone (Trial) (No. 16, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第16号 Clinical Evaluation 2022-04-22 2022-04-18
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Recommended clinical evaluation paths for products related to "12 active implantable devices" and "13 passive implantable devices" in the subcategory of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220406 Clinical Evaluation 2022-04-06 2022-04-06
Status Issued By Level of Legal Effect Product Category Obsolete CMDE/Center for … Work Documents Medical Device
Recommended clinical evaluation paths for products related to "12 active implantable devices" and "13 passive implantable devices" in the subcategory of the Classification Catalogue of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20220406 Clinical Evaluation 2022-04-06 2022-04-06
Status Issued By Level of Legal Effect Product Category Obsolete CMDE/Center for … Work Documents 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
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
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
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
The General Office of the Central Committee of the Communist Party of China and the General Office of the State Council have issued the "Opinions on Strengthening the Governance of Science and Technology Ethics"
Regulation No. Product LifeCycle Issued Date Implemented Date 220509-SC-20220320 Clinical Evaluation 2022-03-20 2022-03-20
Status Issued By Level of Legal Effect Product Category Valid State Council … Normative Documents IVD
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