"Medical Device and Healthcare Industry Trends — October 13, 2026"
"South Korea's medical device exports are recovering after hitting a low in 2023, driven by active expansion into emerging markets like Africa and the Middle East. Regulatory shifts—such as the Ministry of Food and Drug Safety's (MFDS) 'immediate market entry' system for innovative medical devices and the enforcement of the Digital Medical Products Act (DMPA)—are aligning with industry strategies for overseas expansion. Meanwhile, the U.S. FDA's eased regulations on AI and wearable devices are presenting new opportunities for South Korean companies targeting the U.S. market."







