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陕西省医疗器械质量监督检验院 >> 信息动态 >> 医械常识 >> 正文
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陕西省医疗器械质量监督检验院微信公众号
陕西省医疗器械质量监督检验院 >>医械常识 >> 正文
医疗器械产品的适用范围指什么?
作者:周巍 (转) 信息来源:转载 点击数:1695 更新时间:2014/10/26 5:04:14

  医疗器械产品在出厂时都附有说明书,说明书中应标明产品的适用范围。医疗器械的适用范围不得随意夸大或变更,必须与该产品在其《制造认可表》或《产品注册登记表》中的相应内容相一致。产品的适用范围一般是在临床试验的基础上经过食品药品监督管理部门批准的,有其科学性和法定性,因此,消费者在购买前应仔细查看产品的适用范围、禁忌症、注意事项等内容,搞清楚该产品是否适用,必要时,应征求专业医师的意见。

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