This paper introduced the medical device classification in China and USA. Through the comparison between the two systems, several problems in Chinese classification system were exposed. To the end, some suggestions were proposed referred to the classification system of USA.%该文主要介绍了中国和美国医疗器械产品分类的概况，并通过对二者的比较分析，探讨更适合我国现状的医疗器械产品分类工作模式。
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