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Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240312-f1 Clinical Evaluation 2024-03-12 2024-03-08
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … UNKNOWN UNKNOWN
Key points and determination principles for supervision and inspection of clinical trial institutions for medical devices (draft for second round solicitation of opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240312-f2 Clinical Evaluation 2024-03-12 2024-03-08
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … UNKNOWN UNKNOWN
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Key Points and Determination Principles for Clinical Trials of Medical Devices (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231128 Clinical Evaluation 2023-11-28 2023-11-24
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Administrative Regulations Medical Device
Notice on Issuing the Measures for the Review of Science and Technology Ethics (Trial)
Regulation No. Product LifeCycle Issued Date Implemented Date 国科发监〔2023〕167号 Clinical Evaluation 2023-10-08 2023-12-01
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents Medical Device
Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents (Draft for Comments) and Compilation Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230905-2 Clinical Evaluation 2023-09-05 2023-09-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD
Draft Quality Technical Specifications for Clinical Trials of Medical Devices (for Comments) and Compilation Instructions
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230905-1 Clinical Evaluation 2023-09-05 2023-09-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2023年第33号 Clinical Evaluation 2023-07-24 2023-07-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230714 Clinical Evaluation 2023-07-14 2023-07-14
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents IVD
Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230714 Clinical Evaluation 2023-07-14 2023-07-14
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents IVD
Announcement on Adjusting the Management of Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20230627 Clinical Evaluation 2023-06-27 2023-06-21
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Announcements IVD
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