Introduction to South Korea’s Medical Device UDI System

Unique Device Identifier (UDI) requirements in South Korea

Medical device manufacturers active in South Korea must meet Unique Device Identifier (UDI) requirements in order to market their products legally in the country. 

South Korean UDI regulations apply to various device types, including reusable devices intended for more than one use; devices that have been reprocessed for continued use; devices that can be separated or removed from their packaging before use; and more. As in other markets, South Korean UDI regulation requires manufacturers to apply direct, permanent UDI marking on their products.

In this white paper we discuss the purpose of UDI and the recommended preparations to support proper implementation for compliance to South Korean medical device regulations.