Today, artificial intelligence (AI) is not just an innovative technology—it is transforming our daily lives more than we ever expected. This transformation is also taking place in the field of medical products. Recognizing this growing significance of AI technology, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea and the World Health Organization (WHO) will co-host the AIRIS 2025. MFDS and WHO expect the AIRIS 2025 to serve as a platform for regulators and industry to exchange insights and ideas on how to effectively utilize AI in medical product development and regulation.

Since the AIRIS 2024, there have been innovative developments in AI at an incredibly fast pace bringing fundamental changes to the development and approval of medical products. For example, we have seen the implementation of digital twins for refractory disease treatments and the advancement of Large Language Models (LLMs) for analysis of massive safety data and prediction of adverse events.

Against this backdrop, the AIRIS 2025 will continue in-depth discussions on innovation, advancement, safety and reliability of AI-enabled medical products. As the only international symposium in the field of AI-enabled medical products, the symposium will serve as a platform for practical global cooperation among regulatory authorities, businesses, and research and academic institutions.

Yu-Kyoung Oh

Minister of Food and Drug Safety