杨婉娟 李静莉

    [摘要] 医疗器械直接关乎人体健康。规范的命名对准确识别、正确使用医疗器械至关重要，是医疗器械监管的重要基础性工作。美国食品药品监管局通过分类数据库中各级名称进行按类识别，允许企业采用商品名称以释放个性化需求，鼓励企业采用第三方术语系统应对国际贸易，逐步形成了官方和商业互为补充的命名系统。本文概述了美国医疗器械命名现状，梳理了美国医疗器械命名层次、名称种类、名称的应用情况，简述了我国医疗器械命名工作进展，并比较中美医疗器械命名间的异同，分析其潜在原因，以期为我国医疗器械命名系统的建设提供参考。

    [关键词] 医疗器械;监管;命名;美国

    [中图分类号] R197.39? ? ? ? ? [文献标识码] A? ? ? ? ? [文章编号] 1673-7210(2019)01(c)-0049-04

    [Abstract] Medical devices are directly related to human health. Normative naming is very important for accurate identification and correct use of medical devices， and it is also an important basic work of medical device supervision. The United States Food and Drug Administration (FDA) identifies all levels of names in the classified database by category， allows enterprises to use commodity names to release personalized needs， encourages enterprises to adopt third-party terminology system to deal with international trade， and gradually forms an official and commercial complementary naming system. This paper summarized the status quo of medical device naming in the United States， combed the application of the level ......