MedTech Current regulatory intelligence and device recall publications for South Korea.
Article 9 of Korea’s post-market investigation provisions defines overseas-use experience and requires two evidence groups. Clinical or post-market research is one group; overseas authorization, sales, use and adverse-event analysis form the other. Foreign marketing alone does not establish an exemption.
MFDS issued nonbinding guidance on September 30, 2026, for digital medical software that patients use under healthcare professional diagnosis, direction or supervision. It clarifies application information, separate professional and patient instructions, supporting evidence for standalone software and a disclosure checklist.
South Korea's MFDS has issued a new guide for evaluating the clinical accuracy of non-invasive automated blood pressure monitors, outlining auscultatory and invasive reference methods, subject and test-design requirements, analysis methods, and considerations for pregnant populations in alignment with ISO 81060-2.
MFDS has issued guidance on responding to MDSAP-related review scenarios for medical devices in Korea. For manufacturers and Korean import-license holders that already operate under MDSAP, the guidance is relevant to how audit reports and CAPA records may be used to support or simplify Korea-facing inspection and GMP processes.
MFDS has revised its guidance on priority review designation so patient experience data may be used when applying to designate priority-review drugs. The official MFDS page classifies the update under pharmaceuticals and does not establish that the same PED approach now applies to medical-device priority review.