FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

South Korea Introduces Unique Device Identification System

June 11, 2019

South Korean regulators are introducing a Unique Device Identification (UDI) system to help track devices and in vitro diagnostics.

South Korea’s Ministry of Food and Drug Safety, formerly the Korean Food and Drug Administration,  has already set up an enhanced adverse event portal to improve reporting of problem devices.

The UDI system will be introduced in stages, starting with highest-risk Class IV devices in July. Class III devices will come online in July 2020, Class II in July 2021, and Class I in July 2022.

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