关于一次性使用无菌导尿管的审评要求思考  

Thinking about the Review Requirements of Disposable Sterile Catheter

作　　者：湛娜 ZHAN Na(Center for Medical Device Technology Evaluation,State Food and Drug Administration,Beijing,100081 China)

机构地区：[1]国家食品药品监督管理局医疗器械技术审评中心

出　　处：《中国卫生产业》2019年第34期180-182,共3页China Health Industry

摘　　要：该文对一次性使用无菌导尿管进行介绍,对导尿管的类型和特点进行分析,对与之配合使用的润滑剂和涂层进行了分类概述,对其监管类别、风险评估、涉及的国行标和指导原则、条例通告进行阐述,并简要介绍临床评价关注点。对其注册申报时的审评要求、安全性及有效性进行探讨,从技术审评角度展开思考,希望对此类医疗器械注册及技术审评工作有助益。This article introduces the disposable sterile catheter,analyzes the type and characteristics of the catheter,and classifies the lubricants and coatings used in combination with it,its regulatory categories,risk assessment,the national standards and guidelines,and the notices of the regulations are elaborated,and the clinical evaluation concerns are briefly introduced.Discussing the review requirements,safety and effectiveness at the time of registration,and thinking from the perspective of technical review,I hope to benefit from such medical device registration and technical review work.

关 键 词：导尿管 润滑剂 技术审评 风险评估 

分 类 号：R197.39[医药卫生—卫生事业管理]