South Korean medical device industry focuses on global regulatory compliance

At the KIMES BUSAN exhibition, experts and industry leaders discussed strategies for South Korean medical AI and device companies to overcome international regulatory barriers in markets such as China, Japan, the United States, and Europe.

Industry specialists emphasized the importance of 'proactive planning' and 'gap analysis.' By establishing a unified reference based on common requirements from the FDA, CE, and MFDS, companies can address specific local requirements more efficiently, significantly reducing the time needed to enter markets like India, Canada, and Brazil.

The Wonju Medical Industry Promotion Agency also held seminars to support export efforts, covering compliance with US FDA QMSR, ISO certifications, and European MDR. To further assist global expansion, the agency introduced 'G2M,' an AI-based platform designed to provide market intelligence and buyer matching services for domestic firms.