A Study on the Permission Status and Procedure of Artificial Intelligence-Based Software as a Medical Device in Korea

Abstract

As the world becomes an aging society with economic growth, there is a growing interest in healthcare, and the demand for medical devices is increasing. The paradigm shift caused by the development of Information and Communications Technology (ICT) and convergence between industries in the Fourth Industrial Revolution is also demanding major changes in the medical device field, and the launch of Software as a Medical Device (SaMD) based on artificial intelligence technology has recently become active. Therefore, this study aims to analyze the current status and procedures of the approval of software medical devices based on AI technology in Korea, and to address the major regulatory issues in the approval process and propose policy improvement measures. AI-based software medical devices are used in various fields, such as medical imaging diagnosis, treatment planning, and prognosis prediction, and are revolutionizing healthcare, but due to the nature of their technology, they must meet different regulatory requirements than conventional medical devices. This study specifically analyzes the major steps of the approval process, including medical device classification, performance verification, and clinical trials, through major domestic approval cases to identify problems in the approval process and suggest improvement directions to solve them. This study will help to identify problems in the licensing process and suggest ways to improve the licensing process in a way that balances regulation and innovation for the future growth of the domestic AI medical device industry.