医用呼吸道湿化器审评关注点探讨  

Discussion on the Focus of Evaluation of Respiratory Tract Humidifiers for Medical Use

作　　者：陈钿 蔡丹丹 卢晴 CHEN Tian;CAI Dan-dan;LU Qing(Center for Certification and Evaluation Guangdong Drug Administration,Guangdong Guangzhou 510080)

机构地区：[1]广东省药品监督管理局审评认证中心,广东广州510080

出　　处：《中国医疗器械信息》2024年第19期28-30,共3页China Medical Device Information

摘　　要：结合医用呼吸道湿化器的产品特点,以及审评过程中发现的问题,从产品原理、风险、产品研究资料、临床评价、产品技术要求等几个方面探讨该产品审评过程中的重要关注点,以期对产品的注册和审评提供参考。Based on the characteristics of respiratory tract humidifiers for medical use and the problems found in the process of review,this paper discusses the concerns in the process of product review from the aspects of product principle,risk,product research data,clinical evaluation,product technical requirements,etc.,in order to provide some guidance for product registration and review.

关 键 词：医用呼吸道湿化器 技术审评 医疗器械 

分 类 号：TH789[机械工程—仪器科学与技术]