体外诊断试剂临床试验常见问题探讨  

Discussion on Common Problems in Clinical Trials of In Vitro Diagnostic Reagents

作　　者：梁爽 张莹 储云高 LIANG Shuang;ZHANG Ying;CHU Yun-gao(Shanghai Medical Device and Cosmetics Evaluation and Verifi cation Center,Shanghai 200020)

机构地区：[1]上海市医疗器械化妆品审评核查中心,上海200020

出　　处：《中国医疗器械信息》2024年第21期22-24,149,共4页China Medical Device Information

摘　　要：为提高体外诊断试剂临床试验的科学性和规范性,文章结合该类产品技术审评、临床核查经验,以上海市体外诊断试剂临床试验为例,从立卷审查、技术审评和临床核查三个方面梳理存在的问题,并给出改进建议,以期供体外诊断试剂临床试验各参与方和监管人员参考。In order to improve the scientificity and standardization of clinical trials of in vitro diagnostic reagents,based on the author’s experience in technical review and clinical inspection of such products,taking the clinical trial of in vitro diagnostic reagents in Shanghai as an example,this paper summarizes the existing problems from three aspects:filing review,technical review,and clinical inspection,and provides improvement suggestions for all parties involved in clinical trials of in vitro diagnostic reagents and regulator.

关 键 词：体外诊断试剂 临床试验 注册申报 

分 类 号：TH776[机械工程—仪器科学与技术]