South Korea Medical Device Act 2026: MFDS QMS and Distribution Rule Changes

Medical Device Global Market Access · Jul 20, 2026 · 4m

This episode details the significant amendments to South Korea's Medical Device Act, effective July 1, 2026. We cover the two key changes from the Ministry of Food and Drug Safety (MFDS): the formalization of the Quality Management System (QMS) Conformity Recognition Scheme and the new mandatory supply chain record-keeping rules. We explore the impact on manufacturers, importers, and distributors and provide actionable steps for regulatory and quality teams to ensure compliance with these new traceability and oversight requirements. Key Questions: - What are the key changes in South Korea's…