中美两国小儿用医疗器械标准及监管现状  

Present Standards and Regulation of Pediatric Medical Devices in China and USA

作　　者：杨鹏飞[1] 贾健雄[1] 刘宝林[2] 

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,北京100044 [2]上海理工大学医疗器械与食品学院,上海200093

出　　处：《中国药物警戒》2012年第9期528-531,共4页Chinese Journal of Pharmacovigilance

基　　金：国家食品药品监督管理局政策研究课题"小儿用医疗器械的评价与监管"

摘　　要：小儿用医疗器械由于其重要性越来越受到各个国家的重视,同时由于其特殊性,对该类设备的研发和监管均存在着较大难度。本文总结了该类设备在我国的标准及监管现状,并介绍了该类设备在美国的发展情况,着重介绍了与小儿用医疗器械相关的美国医疗器械标准,阐述了存在的具体问题和专家提出的一些建议,以期为小儿用医疗器械的合理使用与监管提供借鉴。Pediatric medical devices are being paid more and more attentions in many countries because of its importance. In this paper, the standards and regulation status of pediatric medical devices in China and USA are summarized. Several documents related to pediatric medical devices issued by FDA are introduced, including guidance for industry and FDA staff, premarket assessment of pediatric medical devices and barriers to the availability of medical devices in- tended for the treatment or diagnosis of diseases and conditions that affect children. Some suggestions are provided to develop the satndards and regulations for pediatric medical device in China.

关 键 词：小儿用医疗器械 指导原则 标准 

分 类 号：R197.39[医药卫生—卫生事业管理]