医疗器械分类方法的讨论与探究

Discussion and research of classifying methods for medical devices

通过对我国现行的医疗器械分类方法进行分析,参照国际标准化组织对医疗器械的分类方法,从分类依据、分类类别等角度进行比较,指出这些分类方法存在的一些缺陷,并在此基础上提出一种医疗器械多级分类方法的构想。

Medical devices can be divided into different categories based on different classification basis. China＇s current medical devices classification methods were analyzed in the article. And medical devices classification methods were compared from the basis of classification to classification category and other angles in the light of the international organization for standardization of medical device classification method. It will point out some defects in these classification methods and put forward a kind of multistage classification method of medical equipment on this basis.