源兴医疗

标题: 哪些医疗器械可以不进行临床试验？ [打印本页]

作者: test4 时间: 2018-8-1 10:20
标题: 哪些医疗器械可以不进行临床试验？
　　众所周知，办理医疗器械注册或者备案事务的人员需要具有相应的专业知识，熟悉医疗器械注册或者备案管理的法律、法规、规章和技术要求，不然医疗器械产品需要不需要进行临床试验都不清楚。那么，哪些医疗器械可以不进行临床试验呢？

　　根据医疗器械监督管理条例的相关规定，第一类医疗器械风险程度低，国家实行产品备案管理，不需要进行临床试验；由于第二类医疗器械具有中度风险，第三类医疗器械具有较高风险，国家对这两类医疗器械实行产品注册管理，所以申请这两类医疗器械产品注册通常需要进行临床试验。

　　不过，有些医疗器械也是可以免于进行临床试验的，具体目录由国务院食品药品监督管理部门制定、调整并公布。一般来说，满足下列情形之一的，可以免于进行临床试验：

　　一、工作机理明确、设计定型，生产工艺成熟，已上市的同品种医疗器械临床应用多年且无严重不良事件记录，不改变常规用途的；

　　二、通过非临床评价能够证明该医疗器械安全、有效的；

　　三、通过对同品种医疗器械临床试验或者临床使用获得的数据进行分析评价，能够证明该医疗器械安全、有效的。

作者: 小想人158 时间: 2018-8-6 02:57
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作者: 小小糊涂神7 时间: 2018-8-9 22:00
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作者: ombky 时间: 2018-8-20 13:43
谢谢分享了!

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作者: gvgwe 时间: 2019-1-24 22:14
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