中国药物警戒 ›› 2012, Vol. 9 ›› Issue (9): 528-531.

• 政策与法规研究 • 上一篇    下一篇

中美两国小儿用医疗器械标准及监管现状

杨鹏飞1, 贾健雄1, 刘宝林2*   

  1. 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
  • 收稿日期:2012-05-29 出版日期:2012-09-10 发布日期:2015-08-07
  • 通讯作者: 刘宝林,男,博士,教授,医疗器械研发及监管。E-mail: blliuk@163.com
  • 作者简介:杨鹏飞,男,博士,助理研究员,医疗器械。
  • 基金资助:
    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”

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

YANG Peng-fei1, JIA Jian-xiong1, LIU Bao-lin2*   

  1. 1 Center for Medical device evaluation, SFDA,Beijing 100044,China;
    2 School of Medical Instrument and Food Engineering, University of Shanghai for Science and Technology,Shanghai 200093, China
  • Received:2012-05-29 Online:2012-09-10 Published:2015-08-07

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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。

关键词: 小儿用医疗器械, 指导原则, 标准

Abstract: 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 intended 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.

Key words: pediatric medical devices, guidance, standard