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South Korea

Korea’s Unique Device Identification (UDI) System: What You Need to Know? 

In recent years, South Korea has implemented a comprehensive Unique Device Identification (UDI) system for medical devices, aiming to enhance patient safety, improve traceability, and align with global standards. As of 2025, understanding and complying with the Ministry of Food and Drug Safety (MFDS) UDI requirements is essential for manufacturers and importers seeking to market medical devices in the Korean healthcare sector.  What is UDI System? The UDI system in South Korea was introduced to...
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Import License Process for Medical Devices in South Korea: A Detailed Overview 

To engage in the importation of medical devices in South Korea, it is crucial to understand the regulatory requirements and obtain the necessary licenses and certifications. This comprehensive guide outlines the essential steps to secure an import business license from the Minister of Food and Drug Safety and comply with all relevant regulations.  Anyone looking to import medical devices must first obtain an import business license from the Minister of Food and Drug Safety. This license is...
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