2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Regulatory_Inspection_69页_821kb

The WHO Global Benchmarking Tool for Medical Devices (GBT+MD) is designed to help National Regulatory Authorities (NRAs) assess and enhance their regulatory inspection systems for medical products. It focuses on ensuring the quality, safety, and efficacy of drugs, vaccines, blood products, and medical devices through structured evaluations. Key areas assessed include legal frameworks, organizational and governance structures, human resources, inspection procedures, data monitoring, and transparency measures. The tool uses maturity levels (Not Implemented, Ongoing Implementation, Partially Implemented, or Implemented) for each sub-indicator to provide a clear assessment of regulatory performance. This enables NRAs to identify gaps, improve processes, and align with international standards like WHO guidelines and ISO requirements.