Liability of Medical Device: Lessons from U.S. Laws
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.