Introduction to South Korea’s Medical Device UDI System

Korea medical device UDI system white paper

This white paper will discuss the basics of the regulation, key points to consider, and recommended preparations to ensure proper implementation of a UDI system.

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This white paper provides an introduction to South Korea's use of the Unique Device Identifier (UDI) system for medical devices. Compliance with the rules established by the Ministry of Food and Drug Safety (MFDS) is mandatory for medical device manufacturers, and deadlines for compliance vary according to device classification. Included here are the regulatory background of UDI in South Korea, key points for stakeholders to consider, and best practices for successfully implementing a UDI system.