🔍 Regulatory Tools Q&A GitHub Home

Korean Medical Device Regulation
Start Here
Pre-Market
Post-Market
Legislation and Regulations
GMP and Quality System (KGMP)
UDI, Registration and Licensing
Guidance Documents
What's New
Special Access and Designations
Digital Health and SaMD
International and Comparison
Enforcement and Compliance

Start Here
Glossary of Key Terms

Glossary of Key Terms

체외진단의료기기법 Cheoewejindan uiryo-gigi-beop In Vitro Diagnostic Medical Devices Act

Sections

Start Here
Pre-Market
Post-Market
Legislation
What's New

Official Sources

MFDS (Ministry of Food and Drug Safety)
NIFDS (National Institute of Food and Drug Safety Evaluation)
Medical Device Information System (UDIKOREA)
Korean Medical Device Act

Community

Q&A Discussions
Report an Error
GitHub

RAPath

All Jurisdictions
Terms
About

Disclaimer: Independent open-source project. Content across all RAPath sites is written with AI assistance and is intended as a navigation aid only — not legal or regulatory advice, and not affiliated with any regulatory authority. All content is derived from publicly available sources only. Always verify against official MFDS and National Law Information Center sources before making any regulatory decision.

Copyright © 2026 RAPath South Korea. Built with Docusaurus and hosted on GitHub Pages.