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

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.