2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Vigilance_53页_676kb

WHO's Global Benchmarking Tool for Medical Devices and Vigilance evaluates national regulatory systems for medical products by assessing vigilance activities, which involve monitoring and responding to adverse events. The tool covers key areas such as legal provisions, organizational structures, human resources, and procedures, with maturity levels ranging from Not Implemented to Implemented to measure progress. It emphasizes harmonization with international guidelines to enhance safety and build public trust.