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South Korea introduces fast-track market entry for AI-based medical technologies

( January 26, 2026, 02:50 GMT | Official Statement) -- MLex Summary: South Korea’s Ministry of Health and Welfare on Monday announced the implementation of the “Immediate Market Entry Medical Technology” system, which allows innovative medical technologies — including those using artificial intelligence — to enter the market more quickly. Under the new system, developed in cooperation with the Ministry of Food and Drug Safety, eligible technologies may enter the market without a separate assessment process, provided the relevant medical devices have completed internationally recognized, advanced clinical evaluations. The system takes effect Monday, following the completion of amendments to relevant rules and regulations. As a result, eligible new medical technologies will be able to enter the market after an entry period of as few as 80 days, compared with up to 490 days previously, the health ministry said.The statement is attached (in Korean)....

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