Korea is gearing up to expand its own homegrown domestically produced medical device business. The country is hoping to develop and export more of its own medical devices internationally. In an effort to do this, a few weeks ago, Korea’s MFDS outlined that it will set up new, delete, or revise over 170 Korean standards. Specifically, the government will set up 35 new standards, revise 100 standards, and delete 35 standards for devices. The goal is to improve Korea’s locally made medical devices and get them closer aligned to international standards. To learn more, please see the Korean Standards website at – www.standard.go.kr.
In addition, the MFDS also published new guidelines on devices with AI and digital therapeutics. The Ministry wants to upgrade its regulatory system to align with the growth in digital medical devices globally. These guidelines outline updated approaches to clinical trials and the review and approval of AI and digital devices in Korea.