国产医疗器械体外诊断试剂采购的资质审核管理  

Management of Procurement Qualification Auditing of Domestic In-Vitro Diagnostic Reagents

作　　者：王静怡[1] 田爽[1] Wang Jingyi;Tian Shuang(Tianjin Third Central Hospital,Tianjin 300170,China)

机构地区：[1]天津市第三中心医院,天津300170

出　　处：《医疗装备》2021年第9期60-62,共3页Medical Equipment

基　　金：科技部“国产创新医疗器械技术保障服务体系研究”(2017YFC0114006)。

摘　　要：随着检验医学的飞速发展,医院检验科、病理科等科室开展定性或定量的临床诊断项目日益增多,且检验试剂的更新换代速度加快。目前,国产检验仪器及体外诊断试剂在性能方面也逐步提升。体外诊断试剂种类繁多、专业性强,采购引进时在资质审核方面具有一定的特殊性。该文总结了在体外诊断试剂采购过程中需要审核的供应商资质,包括商务资质及实验室支持性材料等,并提出在审核工作中的相关注意事项,力求将审核流程规范化、科学化。把好采购入口关,确保采购过程合法、公开、公平,避免采购不合规、不适用、性能低劣的试剂。With the rapid development of laboratory medicine,more and more qualitative or quantitative tests are applied to clinical diagnosis in hospitals'laboratory and pathology departments.Correspondingly,the updating speed of the reagents accelerates,too.At present,the performances of domestic testing devices and in-vitro diagnostic reagents have also been gradually improved.In-vitro diagnostic reagents are various and professional.Qualification auditing is particular for purchasing them.In this paper,the supplier qualification that needs to be reviewed in the processes of reagent procurement were summarized,including business qualification and laboratory supporting materials.Attentions of qualification auditing were put forward,aiming to make the processes standardized and sci entific.It is key to controlling the procurement of reagents,ensuring that the process is legal,open and fair,and avoiding purchasing irregular,unsuitable and poor performance reagents.

关 键 词：国产医疗器械 体外诊断试剂 资质审核 标准化流程 

分 类 号：R197.39[医药卫生—卫生事业管理]