論醫療器材之民事責任：以美國規範為借鏡【本期企劃】 試閱
Liability of Medical Device: Lessons from U.S. Laws
醫療器材管理法草案於2016年12月公布，其立法目的在於控制醫療器材風險、保障消費者權益。上開草案將醫療器材區分為上市查驗與登錄兩類，就他國規範觀之似有不足，諸如：草案尚無醫療器材分級，不利風險控制，亦無豁免原則，以平衡醫療器材責任；移轉負擔之中介原則亦付之闕如，不利病患權益保障。若臺灣規範得落實實質風險分級、劃分責任豁免範圍、強化專家中介義務等，則可控制風險，平衡器材責任，進而鼓勵設備發展，有利於消費者。
The draft legislation of medical device management is released in December, 2016, the legislative purpose of the draft is to control the risk of the medical device and protect the consumer. In the proposal, the medical devices are classified into two types. However, there is no substantial classify system for the medical device to control the risk. The pre-emption is also absent from the draft, consequently, the common-law claim is not preempted by the medical device regulation. Further, the learned intermediary doctrine is not introduced into the draft. The article addresses on the development of the U.S. medical device regulation, and the article suggests introducing the preemption, medical device classification system and the learned intermediary doctrine into the draft legislation to improve the consumer protection.
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