의료기기 산업 발전 방향 예측을 위한 국내 혁신의료기기 개발 동향 분석

Abstract

Innovative medical devices are medical devices with improved safety and effectiveness compared to existing medical devices or treatments, and the system was introduced in Korea in 2019. In addition, related improvements are being implemented in various major countries. In the case of the United States, it was reported that the proportion of Software as Medical Device (SaMD) in innovative medical devices was high. In this study, we analyze the product trends of innovative medical devices designated in Korea and use the results to provide them to industry stakeholders. For this purpose, SaMD was analyzed in terms of number of registrations, purpose of use, risk, purpose of application, and licensing. As a result, a high proportion of innovative medical devices to date have been software products, and devices for diagnostic purposes have been mainly developed. In terms of risk, proportion of medical devices of class 2 or higher that are judged to have a certain degree of risk was higher than that of general medical devices, and were found to be applied to more major parts of the human body. Meanwhile, even for products designated as innovative medical devices, it is believed that more effort will be needed to advance overseas.