体外诊断试剂在使用环节的法规风险探讨

Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use

摘要: 该文结合笔者在对体外诊断试剂临床使用环节的监督检查情况，对发现的合规性问题进行分析，并讨论解决问题的方法，旨在督促医疗机构降低体外诊断试剂产品在使用环节的法规风险。

Abstract: According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.