새로운 과학기술 도입과 의료기기 해당성 판단

The Medical Device Act defines the term "medical device" as an instrument, machine, device, material, or any other similar product alone or in combination for human beings or animals such as a product used for the purpose of diagnosing, curing, alleviating, treating, or preventing a disease; a product used for the purpose of diagnosing, curing, alleviating, or correcting an injury or impairment; a product used for the purpose of testing, replacing, or transforming a structure or function; a product used for birth control. To determine whether the Medical Device Act regulates specific use of certain products or devices, the court’s interpretation is required. The applicability of the term "medical device" in Medical Device Act has been developed, interpreted and refined by the rulings of the Supreme Court. Interpreting and, thus, deciding whether the Medical Device Act shall be applied in specific cases plays crucial roles in shaping the scope and subject of the regulation of the medico-legal system; including regulatory approval for developing and producing medical products, clinical trials as well as regulating medical advertisements. The question of whether a device or product shall be regulated as a medical device can only be answered individually taking into account the development of society and technologies because of the inherent limitations on legislative techniques. Legislation cannot spontaneously reflect the rapid development of medical technologies as well as bio-technologies and information technologies. Thus, when deciding applicability of the term “medical device” in certain use of a device or product, one should take the general principle of objective of the law into account as well as risks and peculiarities of individual devices.