| 關 鍵 詞： |
有學問之中間人原則；消費者保護法；產品責任；醫療軟體；醫療器材 |
| 中文摘要： |
醫療器材因其特殊性，在產品責任之論斷上值得探究之處有三：一、單純之醫療器材軟體是否屬於產品責任法所涵蓋之「產品」？二、醫療器材製造者在產品安全性指示及警告義務上之嚴格責任，是否應予調整？三，除醫療器材管理法外，民法體系上另有消費者保護法及民法第 191 條之 1 等規定，法律上應如何適用之？本文由此三個爭點切入，依序分析醫療器材之產品責任，俾供學界及實務界先進參酌。
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| 英文關鍵詞： |
learned intermediary doctrine；Consumer Protection Act；product liability；medical software；medical devices |
| 英文摘要： |
The exploration of judgment on product liability for medical devices, given their unique nature, involves three key issues: First, whether the medical device of pure medical software falls within the "product" covered by product liability law. Second, whether there should be adjustments to the strict liability of medical device manufacturers with respect to product safety instructions and warnings. Third, in addition to the Medical Devices Act, there are other provisions in the civil law system, such as the Consumer Protection Act and Article 191-1 of the Civil Code. How should these legal aspects be applied? This article addresses these three points to systematically analyze product liability for medical devices and provide insights for academic and practical reference.
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| 目 次： |
壹、前言
貳、醫療軟體之產品責任
參、醫療器材之指示及警告義務
肆、醫療器材損害賠償責任之法律適用
一、法律關係
二、責任客體
三、權利主體
四、責任主體
五、歸責原則
六、連帶責任
七、損害賠償範圍
伍、結論
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