공산품과 결합된 의료기기의 수리절차 규제개선에 관한 연구

Improvement of Regulatory Laws for Repair Process of Medical Devices Combined with Industrial Products

According to the need for spreading self-care preferences, new convergence products have been seen in medical device industries. Although medical equipments and devices with IT technologies can lead to new growth engines, related laws are complex to specify and support the service and market. Used medical equipments utilized in medical technologies, most are not human or environmental risks likely to in normal medical technology. Therefore, the risk is close to zero so that medical devices are classified into Class 1 medical device, such as little or no risk by treating. It can be minimized without arising unnecessary and waste of time. In this paper, our research are presented to improve the legal and regulatory directions for the distribution of used medical devices in order to establish and promote a fair deal of diversity.