生化类检测试剂盒监督抽验问题探讨  

Discussion on Supervision and Sampling of Biochemical Test Kits

作　　者：黄宇哲 吴静标[1] HUANG Yuzhe;WU Jingbiao(Division IV of General Laboratory,Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,510663)

机构地区：[1]广东省医疗器械质量监督检验所综合检验四室,广州市510663

出　　处：《中国医疗器械杂志》2022年第2期216-218,236,共4页Chinese Journal of Medical Instrumentation

基　　金：广州市科创委项目(201803040014)。

摘　　要：体外诊断试剂作为医疗器械的重要组成部分,是预防和诊断、保障人民健康的重要手段。监督抽验是确保体外诊断试剂产品合格的关键监管手段。总结近年生化类检测试剂盒监督抽验遇到的问题,分析这些问题产生的原因,并提出相应的建议,希望为监督抽验提供建设性建议。As an important part of medical devices,in vitro diagnostic reagents are important means to prevent and diagnose and protect people’s health.Supervision and sampling is an important and key supervision method to ensure the in vitro diagnostic reagent products are qualified.This paper summarizes the problems encountered in recent years in vitro diagnostic quantitative testing kit supervision sampling,analyzes the causes of these problems,and puts forward corresponding suggestions,hoping to provide constructive suggestions for supervision sampling.

关 键 词：体外诊断 IVD 监督抽验 

分 类 号：F203[经济管理—国民经济]