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Understanding UDI Series
Gain answers to your questions about Unique Device Identification (UDI). Book time with a UDI expert for in-depth Q&A plus access to a library of tutorials and reference materials
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.
Slides and PDF
Video Tutorials
Understanding UDI
Unique Device Identification (UDI) requirements vary by country and regulatory authority. Select a health authority below to access jurisdiction-specific guidance and resources.
USA
EUROPEAN UNION
CHINA
SOUTH KOREA
AUSTRALIA
SWITZERLAND
Need Guidance on UDI Compliance?
Understanding UDI obligations across global health authorities can be complex. Whether you are preparing for initial submission, managing product data updates, or aligning compliance across multiple markets, our regulatory experts provide practical guidance tailored to your organization’s needs.
