'AIRIS 2025' Opens to Discuss AI Medical Product Regulations

Co-hosted by the Ministry of Food and Drug Safety and WHO, September 10-12 in Incheon
Over 600 regulatory, industry, and academic experts from around the world to participate

The Ministry of Food and Drug Safety announced on September 10 that, in collaboration with the World Health Organization (WHO), it will host the 'International Artificial Intelligence Medical Product Regulatory Symposium (AIRIS 2025)' to discuss the utilization of artificial intelligence (AI) in medical products with regulatory authorities, industry, and academia representatives from around the world.

The symposium, held for three days until September 12 at the Inspire Hotel in Incheon, will be attended by approximately 600 participants, including medical product regulatory officials from 21 countries such as those in Europe, Japan, Singapore, Malaysia, Indonesia, Australia, Brazil, and Nigeria, as well as representatives from international organizations such as WHO and the International Telecommunication Union (ITU), and global industry and academic experts.

At AIRIS 2025, 23 global speakers will share the latest information on technological trends and innovative case studies and experiences regarding AI applications in the medical product sector. In-depth discussions will be held on the step-by-step application of AI technology to medical products, and on regulatory considerations required throughout the entire lifecycle from the development to commercialization of safe and effective AI medical products.

The opening ceremony on the first day will begin with a congratulatory video message from Prime Minister Kim Minseok, emphasizing the establishment of AI governance in Korea, followed by opening remarks (video) from Oh Yu-kyoung, Commissioner of the Ministry of Food and Drug Safety, and Tedros Adhanom Ghebreyesus, Director-General of WHO, highlighting the importance of global regulatory harmonization and cooperation for AI medical products.

The symposium will be comprehensively highlighted with a keynote speech (video) by David Baker, professor at the University of Washington and recipient of last year's Nobel Prize in Chemistry. In the afternoon, there will be presentations and discussions on the latest AI technologies and regulatory trends in the pharmaceutical sector, opportunities and challenges of AI-based protein structure prediction in new drug development, efficient clinical trials using AI, and the application of digital twins (virtual models) and generative AI in medical products.

On the second day, September 11, Ha Jungwoo, Chief of AI Future Planning, will deliver a congratulatory video message emphasizing the importance of national competitiveness and AI. In the morning, presentations will focus on 'Regulatory Frameworks for AI-Enabled Medical Products,' with regulatory officials from various countries sharing policy and approval case studies and regulatory trends. In the afternoon, global industry and academic speakers will engage in in-depth discussions on technical and regulatory considerations across the entire lifecycle when applying AI technology in the medical product sector.

On the final day, a closed meeting involving regulatory authorities will be held, where officials from each country will present on AI policy directions, approval reviews, and other regulatory considerations. A roundtable meeting will follow to discuss solutions to common challenges and ways to enhance cooperation.

During the symposium, the Ministry of Food and Drug Safety will hold bilateral meetings with regulatory authorities from Malaysia, Nigeria, and Egypt to strengthen mutual cooperation with major export countries. Additionally, it will operate an international forum for medical device export companies and organize various side events, including exhibitions of outstanding domestic and international medical devices, to actively support domestic companies' entry into overseas markets.

Commissioner Oh Yu-kyoung stated, "Through AIRIS 2025, we aim to lead regulatory harmonization and global cooperation in the AI medical product sector and, by working with major national regulatory agencies, establish a new framework for AI regulation." She added, "We will continue our utmost efforts to strengthen the international competitiveness of domestic AI-enabled medical products."