Korea in the Global Regulatory Landscape
Korea is a significant medical device market and an active participant in global regulatory harmonisation through IMDRF.
Korea's market position
- Korea is the 4th largest medical device market in Asia (after Japan, China, and India)
- Korea is both a major importer (devices from US, EU, Japan) and exporter (Korean manufacturers are significant players in diagnostic, electronic, and surgical device markets)
- Key Korean medical device manufacturers include Samsung Medison (ultrasound), Hugel, Vuno (AI diagnostics), and many others
Regulatory reputation
MFDS is generally considered a rigorous but scientifically engaged regulator, comparable in standards to the FDA, TGA, and EU competent authorities.