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Latest Regulations

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Policy Interpretation of the Implementation Rules of the Regulations on the Management of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230601 Clinical Evaluation 2023-06-01 2023-06-01
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents IVD
Implementation Rules for the Regulations on the Management of Human Genetic Resources, Order No. 21 of the Ministry of Science and Technology
Regulation No. Product LifeCycle Issued Date Implemented Date 科学技术部令第21号 Clinical Evaluation 2023-06-01 2023-07-01
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Departmental Rules IVD
Notice on Public Solicitation of Opinions on the Key Points for Clinical Trial Technical Evaluation of Sodium Hyaluronate Composite Solution (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230517 Clinical Evaluation 2023-05-17 2023-05-17
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Review Key Points Medical Device
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Supervision and Inspection of Clinical Trial Institutions of Medical Devices (Draft for Solicitation of Opinions)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20230407 Clinical Evaluation 2023-04-07 2023-04-04
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Classification Catalogue of Medical Devices (No. 30, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第30号 Clinical Evaluation 2022-07-14 2022-07-14
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
Announcement on the Migration and Renaming of the Human Genetic Resources Information Backup Platform
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20220711 Clinical Evaluation 2022-07-11 2022-07-11
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Announcements IVD
Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 02, 03, 05, 06, 16, 18, and 20 of the Classification Catalogue of Medical Devices (No. 24, 2022)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2022年第24号 Clinical Evaluation 2022-06-16 2022-06-16
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
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
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
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