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我国发布新修订的《医疗器械分类目录》

2017-09-04 19:15:40   新华网

新华社北京9月4日电(记者陈聪)记者4日从国家食品药品监督管理总局新闻发布会上了解到,食药监总局当天发布新修订的《医疗器械分类目录》,自2018年8月1日开始实施。

对医疗器械进行分类是实施医械分类管理的条件和基础,涉及注册、生产、经营、使用等各个环节,可谓“牵一发而动全身”。中国食品药品检定研究院院长李波在发布会上指出,新分类目录侧重于从医疗器械的功能和临床使用的角度划分归属产品,设置22个子目录,将现行的260个产品类别细化调整为206个一级产品类别和1157个二级产品类别,提高分类的科学性和指导性,同时在目录中附有关于预期用途和产品描述的内容,并列举6609个品名举例,有利于统一各方认识和执行。

食药监总局器械注册司司长王者雄在发布会上表示,在新分类目录实施方面,食药监总局给予有关方面近一年的过渡时间,以加深各方面对新分类目录的了解和认识。在注册管理方面,新分类目录实施前批准注册的产品仍按照现行分类目录核发医疗器械注册证;新分类目录实施后全部按照新分类目录进行受理、审评、审批。

对于第一类医疗器械备案工作,王者雄指出,2018年8月1日前已完成备案的第一类医疗器械产品,原备案凭证继续有效。自2018年8月1日起,应当按照新分类目录和相关文件规定实施备案。

据王者雄介绍,新分类目录按照《医疗器械分类规则》制定完成,在一定时期内《医疗器械分类规则》是相对稳定的。在产品的生产、经营、使用过程当中,食药监总局将根据产品风险程度的判断,对部分产品管理类别进行动态调整,实现医械分类的精准性和科学性。

据了解,现行《医疗器械分类目录》为2002年发布实施,包括43个子目录。

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