穿戴裝置醫療認定之界限──COMGO案：如何判斷是否屬於醫療器材【學習式判解評析】 試閱
The Limit of Indentification of Wearable Devices as Medical Treatment: The Case COMGO——How to Categorize an Item into Medical Devices
對於穿戴裝置是否應以醫療器材規範之，容有經濟利益與使用者健康保障之衡量，關鍵在於宣稱之功能是否達診斷之程度，因此產品說明書即成是否屬於醫療器材重要判斷之參考，並非以實際功能加以決定，法院對於主管機關函示之審查也必須尊重專業判斷。 對於穿戴裝置是否應以醫療器材規範之，容有經濟利益與使用者健康保障之衡量，關鍵在於宣稱之功能是否達診斷之程度，因此產品說明書即成是否屬於醫療器材重要判斷之參考，並非以實際功能加以決定，法院對於主管機關函示之審查也必須尊重專業判斷。
Whether a wearable device should be regulated as a medical device depends on the balance between economic benefits and the protection of the user’s health. The Key is whether the claimed function reaches the diagnostic level. Therefore, the product description becomes an important reference to determine whether it is a medical device, rather than deciding based on the actual function. Furthermore, the court’s review of the authority’s instruction must also respect the professional judgment.
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