Korean Medical Device Regulation

Welcome to RAPath Korea — your plain-English guide to the Korean medical device regulatory system overseen by the Ministry of Food and Drug Safety (MFDS, 식품의약품안전처).

What this site covers

Korea operates two primary statutes for medical devices:

• Medical Devices Act (의료기기법) — medical devices classified as Grades I–IV
• In Vitro Diagnostics Medical Devices Act (체외진단의료기기법) — IVD devices (effective May 2021)

Quick navigation

Goal	Start here
New to Korean regulation	Start Here → What is a medical device?
Getting a product to market	Pre-Market → Classification
Foreign manufacturer	GMP → Foreign Manufacturers
Post-market obligations	Post-Market → Overview
UDI registration	UDI-K Overview

Disclaimer

For informational purposes only — not legal advice. Always consult official MFDS publications and qualified regulatory professionals.