新法规体系下体外诊断试剂类产品临床试验要求的变化

摘要

《体外诊断试剂注册管理办法》（总局令第5号）已经发布实施，相应的体外诊断试剂临床试验技术指导原则也已配套发布实施，本文结合相关法规和指导原则中对临床试验的要求，阐述新法规体系下体外诊断试剂类产品临床试验的具体要求和变化。%Provision on IVD registration(CFDA Decree No.5) had been issued and published by CFDA, fol owing, the guidance for clinical trial of IVD had been posted on CFDA’s website, this paper study the requirements from regulation and guidance, elaborate the speciifc requirements and the change of requirements for clinical trial of IVD.