Bring Your Korean License Back Into Compliance — Before Renewal Forces Your Hand.
We compare your current device, labeling, manufacturing-site, and intended-use specifications against the data on file with MFDS — across the full license portfolio — and produce a structured inventory of every undeclared change with its impact and urgency.
Each undeclared change is classified per MFDS criteria as Major (substantive filing) or Minor (notification), and the filings are sequenced for efficiency — grouping where permitted, separating where required, and prioritizing items that gate renewal.
We prepare and submit each change-notification filing package in Korean, manage MFDS reviewer correspondence through approval, and update your portfolio compliance record once each filing is confirmed.
An audit-defensible record of every change filed, classified, and approved — handed over with an updated portfolio compliance calendar.
Request assessmentYears of undeclared device, labeling, site, or intended-use changes leave most foreign portfolios out of sync with MFDS records. Discovered at renewal — when there's no time left to spread the filings out.
Undeclared change inventory and impact assessment across the portfolio
Change classification memo (Major / Minor per MFDS criteria) with filing strategy
MFDS change-notification filing packages in Korean, one per change
Submission and approval confirmation record for every filing
Updated MFDS license record reflecting all filed changes
Common questions about License Compliance Update.