🇰🇷
South Korea Medical Device Registration Fees
MFDS government fees for 2025
KRW 85,000
Low Risk Min
KRW 1,495,000
High Risk Max
MFDS
Authority
2025-12-16
Last Updated
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Approval - Class 1 Pre-market notification | KRW 85,000 | Per approval |
Approval - Class 2 (with S.E.) 35 days · Substantial equivalent | KRW 130,000 | Per approval |
Approval - Class 2 (without S.E.) 80 days · Requires clinical data | KRW 1,495,000 | Per approval |
Approval - Class 3/4 (with S.E.) 65 days · Substantial equivalent | KRW 719,000 | Per approval |
Approval - Class 3/4 (without S.E.) 80 days · Requires clinical data | KRW 1,495,000 | Per approval |
Important Notes
- •S.E. = Substantial Equivalent (predicate device exists)
- •Without S.E. = Novel device requiring clinical data
- •KGMP certification required ($4,000-$6,000)
- •All fees in KRW (Korean Won)
Frequently Asked Questions
Government fees are subject to change. Last data update: 2025-12-16. Always verify current fees with MFDS.