临床化学体外诊断试剂技术审评规范分析  

Analysis of Technical Evaluation Standards for In Vitro Diagnostic Reagents in Clinical Chemistry

作　　者：王玉 杨阳 郑秀娥 崔涛 李国勇 耿友军 夏文龙 WANG Yu;YANG Yang;ZHENG Xiu-e;CUI Tao;LI Guo-yong;GENG You-jun;XIA Wen-long(Shandong Provincial Food and Drug Evaluation and Inspection Center,Shandong Jinan 250014)

机构地区：[1]山东省食品药品审评查验中心,山东济南250014

出　　处：《中国医疗器械信息》2024年第11期18-20,137,共4页China Medical Device Information

摘　　要：文章主要针对按照第二类医疗器械管理的临床化学体外诊断试剂产品,以碱性磷酸酶测定试剂盒为例,从适用范围、性能评估、临床评价等方面,深入探讨产品注册申报过程中的技术审评规范,进一步提高审评审批时效,为企业注册人员和审评人员提供参考和帮助。This article mainly focuses on clinical chemical in vitro diagnostic reagent products managed according to the second category of medical devices.Taking alkaline phosphatase assay kits as an example,from the aspects of applicability,performance evaluation,clinical evaluation,etc.,it deeply explores the technical review standards in the registration and application process,further improving the review and approval efficiency,and providing reference and assistance for enterprise registrants and reviewers.

关 键 词：临床化学体外诊断试剂 技术审评 审评规范 

分 类 号：TH776[机械工程—仪器科学与技术]