Your Gap Analysis is Complete. Now Get the Approval.
Submission is where most foreign manufacturers lose 12 months they cannot recover.
Compiling a compliant Korean Technical File requires MFDS expertise that no translation agency can replicate. When the MFDS reviewer issues a deficiency letter — and they will — manufacturers without a Korea-side regulatory team exhaust their response cycles, triggering a full resubmission and adding 9 to 12 months to their launch timeline.
Turn-key execution from Technical File authoring to license.
We execute the entire Korean registration project on your behalf — from document authoring to MFDS submission to deficiency defense — until your certificate is issued.
Korean Technical File Authoring
Reconstructed from your existing data to MFDS structural and content standards. Not a translation — a Korea-native regulatory document built from the ground up.
MFDS Submission Management
Full preparation, packaging, and official submission through the MFDS portal, including all intake confirmation and logistics.
Deficiency Letter Defense
Citation-backed, logically structured responses to every MFDS reviewer query — protecting your review timeline and eliminating the risk of forced resubmission.
The Product License
You receive a fully issued MFDS product license. Every milestone is billable only upon completion.
- Complete Korean Technical File, authored in Korean to current MFDS requirements.
- Official MFDS submission package with all required forms, declarations, and attachments.
- Written deficiency response letters for every reviewer query received during the review period.
- Final MFDS product license, delivered upon official issuance.
Every month of delay is lost revenue. Eliminate that risk entirely.
A single poorly drafted deficiency response resets your review clock and forces a resubmission cycle that costs 9 to 12 additional months. By placing the entire execution under one accountable team with direct MFDS experience, you protect your approval timeline and enter Korea with a registration built to withstand post-market scrutiny.
Speak with a Registration Project Lead TodayFrequently Asked Questions
Common questions about the Korean Technical File registration process.