摘要
该研究从技术审评的角度对近年陆续上市的液质联用检测医疗器械产品的申报与临床应用进行了梳理,对比分析了中国、美国、欧盟、日本等对该类产品的监管要求,结合上市后不良事件监测情况、可参考的标准和国内外法规依据文件,分析了该类产品的临床应用和监管风险。针对该类产品前处理、系统匹配性、性能指标要求的充分性、室间一致性、参考区间、注册单元等问题进行了探讨并给出监管建议,以期为该领域的产品研发生产和审评审批监管提供技术参考。
From the perspective of technical evaluation,this study reviewed the current situation of application and clinical application of medical device products were detected by liquid chromatography-tandem mass spectrometry in the market in recent years.The regulatory requirements of these products in China,USA,EU and Japan were compared and analyzed,and the monitoring situation of adverse events after listing,the standards for reference and the domestic and foreign regulatory documents were combined,the clinical application and regulatory risks of the product were analyzed.The problems such as pre-treatment,system matching,adequacy of performance index requirements,inter-room consistency,reference interval and registration unit were discussed and suggestions for supervision were given,with a view to thefield of product R&D and production,review and approval of supervision to provide technical reference.
作者
叶朝付
张兰
寇艳芹
王宇航
杨笑鹤
YE Chaofu;ZHANG Lan;KOU Yanqin;WANG Yuhang;YANG Xiaohe(Zhejiang Center for Medical Device Evaluation(Zhejiang Provincial Center of Medical Device Adverse Events Monitoring),Hangzhou,310009)
出处
《中国医疗器械杂志》
2023年第6期690-694,共5页
Chinese Journal of Medical Instrumentation
基金
浙江省科技计划项目(2021C35085)。
关键词
液质联用技术
临床实验室自建项目
临床评价
真实世界数据
一致性
liquid chromatography-tandem mass spectrometry(LC-MS)
laboratory developed tests(LDTs)
clinical evaluation
real-world data
consistency
作者简介
叶朝付,E-mail:594273194@qq.com;通信作者:杨笑鹤,E-mail:147359549@qq.com。
