South Korea MFDS/IMDIS UDI Requirements & Compliance Resources
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South Korea MFDS/IMDIS
South Korea has implemented a national Unique Device Identification (UDI) framework administered by the Ministry of Food and Drug Safety (MFDS) to strengthen regulatory oversight and supply chain transparency. The system is supported by the Integrated Medical Device Information System (IMDIS), which manages device registration, class-based UDI requirements, and Track and Trace reporting obligations.
Implementation has progressed across device classifications, requiring manufacturers placing products on the South Korean market to submit and maintain accurate UDI data within IMDIS. As reporting and lifecycle obligations expand, companies operating across multiple jurisdictions must coordinate product data management to remain compliant with MFDS requirements while aligning with other global UDI systems.
As part of the Understanding UDI Series, this page provides access to slides, PDFs, video tutorials, and related resources to support organizations managing South Korea MFDS UDI compliance.
LexisNexis Life Sciences simplifies that complexity. We support manufacturers across the entire product lifecycle — from initial market entry and UDI data preparation to ongoing updates, change management, and post-market compliance. Our global regulatory expertise and technology-driven solutions help ensure your device data stays accurate, synchronized, and inspection-ready, so you can focus on innovation while we help safeguard compliance.
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