中国药物警戒 ›› 2012, Vol. 9 ›› Issue (5): 292-296.

• 管理及工作研究 • 上一篇    下一篇

中美天然胶乳避孕套说明书及标签管理法规比较研究

杨晓冬   

  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
  • 收稿日期:2012-03-20 出版日期:2012-05-10 发布日期:2015-08-10
  • 作者简介:杨晓冬，男，硕士，主治医师，医疗器械评价。

Comparative Study of Natural Rubber Latex Condom Labeling Regulation in USA and China

YANG Xiao-dong   

  1. Center For Medical Device Evaluation, SFDA, Beijing 100045, China
  • Received:2012-03-20 Online:2012-05-10 Published:2015-08-10

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摘要： 目的为我国天然胶乳橡胶避孕套标签的规范化管理提供借鉴。方法采用内容分析的方法，对目前美国FDA及我国SFDA关于天然胶乳橡胶避孕套标签的管理法规进行对比分析。结果美国FDA关于天然胶乳橡胶避孕套标签的管理法规体系完整、完善，对产品的风险可以进行有效控制，操作性强，值得我国有关监管机构借鉴。结论我国可从以下方面完善天然胶乳橡胶避孕套标签的法规建设和管理：①尽快修订《医疗器械说明书、标签及包装标识的管理规定》，对天然胶乳橡胶避孕套制订针对性条款;②配套出台天然胶乳橡胶避孕套标签指导原则;③建立标签查询数据库平台。

关键词: 天然胶乳橡胶避孕套, 标签, 管理

Abstract: Objective Provide references for the standardized management of labeling for natural rubber latex condom in China. MethodsBy content analysis, compare U.S. FDA regulations on labeling for natural rubber latex condom with China SFDA's. ResultsU.S. FDA regulatory system for natural rubber latex condom labeling is complete, which can effectively control the risk of natural rubber latex condom, being operational, it is worth for the relevant regulatory authorities in China to learn from. ConclusionChina can improve the natural rubber latex condom labeling regulations construction and management from the following areas: to amend the medical equipment manuals, labels and packaging and labeling regulations, as soon as possible, it is necessary to formulate the terms of natural rubber latex condoms; to establish guidance document of labeling for natural rubber latex condom; to create the database platform of labeling for natural rubber latex condom to query.

Key words: natural rubber latex condom, labeling, comparative study