中国医疗器械分类目录全面修订的设计与思考

Design and Consideration on the Revision of China Medical Device Classifcation Directory

摘要: 新版《医疗器械分类目录》（修订草案）已向社会公开征求意见，该文简要介绍了我国医疗器械分类目录发展历史以及此次目录修订的背景和主要过程，重点分析了新版目录的主要变化和修订思路，以帮助监管部门、生产企业、经营及使用单位等更好地理解和使用新版分类目录，为其顺利实施奠定基础。

Abstract: The new version of Medical Device Classification Directory(revised Draft) has opened to the public comments. This paper briefly introduces the classification of medical device in China and the historical development of the directory, and focuses on the analysis of the main changes in the new version of the directory to help the supervision department, manufactures, and related organizations better understand and use the new directory.