摘要
Abstract
The World Health Organization(WHO)prequalification program for in vitro diagnostic(IVD)products is a globally trusted mechanism for ensuring safety,quality,and performance.United Nations agencies,non-UN donor organizations,procurement agents,and certain low-and middle-income countries use prequalification as a reference for IVD procurement.Given the complexity of IVD development,manufacturing,and regulation,WHO conducts prequalification through stringent evaluation procedures and guidance documents,combining performance evaluations,expert reviews,on-site inspections,and post-qualification monitoring.This paper provides a comprehensive overview of WHO IVD prequalification,including its significance,scope,processes,and requirements,with the aim of assisting domestic manufacturers intending to apply for WHO prequalification.关键词
体外诊断试剂/世界卫生组织/预认证/指南/专家评审机制Key words
in vitro diagnostics/World Health Organization/prequalification/guidelines/expert review panel分类
医药卫生
