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国家食品药品监督管理总局令第15号《医疗器械分类规则》已经2015年6月3日国家食品药品监督管理总局局务会议审议通过,现予公布,自2016年1月1日起施行。局长毕井泉2015年7月14日第一条为规范医疗器械分类,根据《医疗器械监督管理条例》,制定本规则。第二条本规则用于指导制定医疗器械分类目录和确定新的医疗器械的管理类别。第三条本规则有关用语的含义是:(一)预期目的指产品说明书、标签或者宣传资料载明的,
The State Food and Drug Administration Order No. 15 “Medical Device Classification Rules” has been reviewed and approved by the State Council’s SFO office affairs conference on June 3, 2015 and is hereby promulgated and will come into force on January 1, 2016. Secretary Bi Jingquan July 14, 2015 Article 1 For the purpose of regulating the classification of medical devices, these Rules are formulated in accordance with the “Regulations on the Supervision and Administration of Medical Devices”. Article 2 These Rules are used to guide the development of classification catalog of medical devices and to determine the management categories of new medical devices. Article 3 The meanings of the terms in these Rules are: (1) The intended purpose means that the product specification, label or advertising materials contain,