2022-02-28-世界卫生组织-WHO_global_benchmarking_tool_plus_medical_devices_rev._VI+_MD_ver._1_–_Laboratory_Testing_56页_689kb

The WHO Global Benchmarking Tool Plus Medical Devices (GBT+MD) evaluates national regulatory authorities' (NRAs) laboratory testing systems for medical products. Its main goal is to ensure that these systems are competent and effective through a structured framework with categories like legal provisions, organization, human resources, and infrastructure. Key elements include sub-indicators with maturity levels (Not Implemented, Ongoing Implementation, Partially Implemented, Implemented), guiding improvements for public health. Outcomes help assess whether labs can consistently perform quality testing, support regulatory decisions, and contribute to international harmonization by incorporating documented procedures, training, facilities, and performance monitoring.