什么样的才是医疗器械
现在很多产品，为了好卖都会冠名医疗或者保健类的产品，其实功能也很简单，测心率啥的。。。等功能好像测量类就可以搞定，不需要医疗指令吧这个医疗指令，医疗器械应该如何去准确划分呢？
求各位大大指教，感激不尽 你看醫療器械定議,寫的很清楚啦.
any instrument, apparatus, appliance, material or other Article, whether used alone or in
combination, including the software necessary for its proper application intended by the
MANUFACTURER to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means. brent 发表于 2015-12-8 11:38 static/image/common/back.gif
你看醫療器械定議,寫的很清楚啦.
any instrument, apparatus, appliance, material or other Article, whe ...
谢谢，但是监测这种就很难说把，测量个心跳的啥的 这个不是三言两语能说清的。
不过在很大程度上取决于对预期用途的声称，比如按摩仪，如果声称止痛就会是医疗设备，如果只是缓解疲劳，放松就不是医疗设备。心率计如果用于运动时的检测不属于医疗设备，如果用于患者医疗性质的监控，就会是医疗设备。这个声称有时候需要技巧。
另外，多参考市场同类产品很有必要的。 學習了:):) jcyxb 发表于 2015-12-8 13:12 static/image/common/back.gif
谢谢，但是监测这种就很难说把，测量个心跳的啥的
通常来说是的，就连创可贴都算是医疗器械 5楼说的很对~
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