This resource is the 2025 edition of the Korean medical device regulatory FAQ (original Korean version), compiling the questions companies most often encounter in medical device licensing, filing and post-market management in Korea, together with official answers.
About this document
Medical devices in Korea are regulated by the Ministry of Food and Drug Safety (MFDS) under the Medical Devices Act, with a four-tier (Class 1–4) risk classification. This Q&A collection explains in question-and-answer form how regulatory provisions are applied in practice, and is a practical reference for understanding Korea’s regulatory approach.
Applicable products and users
- Medical device and in vitro diagnostic (IVD) companies planning to export to Korea
- Regulatory specialists who need to understand Korea’s licensing, certification and notification routes
Main contents
- Medical device classification and determining the licensing / certification / notification route
- Common questions on technical documentation, clinical data and GMP review
- Q&A on labelling, advertising and post-market management
Download
Related articles
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.