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).
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.
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 |
This website is provided for informational purposes only and does not constitute legal, regulatory, or professional advice. Regulations and requirements change frequently. For the most current and authoritative information, always consult:
- Official MFDS publications and guidance documents
- The Korean Ministry of Food and Drug Safety website (www.mfds.go.kr)
- Qualified regulatory professionals or consultants familiar with Korean medical device law
Regulatory Pathways and Timelines
Korea offers several pathways for medical device approval depending on device classification and risk profile:
- Standard Review: Typical timeframe of 6–12 months for Grade II and III devices
- Expedited Review: Available for priority devices, innovative technologies, and breakthrough devices
- Conditional Approval: For devices meeting unmet clinical needs
- Mutual Recognition: Products approved by recognized overseas regulators (FDA, CE mark) may follow streamlined processes
Review timelines vary based on completeness of submission, device complexity, and whether additional clinical data is required.
Regulatory Costs
Manufacturers should budget for:
- Application fees (vary by device classification and review pathway)
- GMP certification and inspection fees
- Post-market surveillance and adverse event reporting fees
- Annual registration and renewal fees
Fees are updated annually by MFDS. Consult the official MFDS fee schedule or a qualified regulatory professional for current costs.
Key Regulatory Distinctions
Domestic vs. Foreign Manufacturers: Foreign manufacturers must appoint a local importer/representative in Korea responsible for compliance, pharmacovigilance, and adverse event reporting. Domestic manufacturers retain direct responsibility with MFDS.
Key Timelines and Deadlines Manufacturers should be aware of important regulatory timelines: • Standard review period: typically 6 months for Grade II–III devices • Expedited review available for priority devices and products addressing unmet medical needs • Post-market surveillance reports due annually • UDI registration must be completed before product launch
Official Resources For the most current regulatory guidance and official information: • MFDS Official Website: www.mfds.go.kr • Medical Device Division contact information and inquiry procedures • Online submission portal for pre-market and post-market notifications