Class I Should Be Fast. Without the Right Setup, It Won't Be.
MFDS Class I registration operates through the 신고 (notification) pathway. Foreign manufacturers routinely over-engineer or under-prepare their submissions — either way destroying the speed advantage Class I is specifically designed to provide.
Scoped Exactly for Class I — Nothing More, Nothing Less.
We apply precisely the regulatory effort Class I requires, without over-engineering or cutting corners.
Regulatory Pathway Strategy (Class I Scoped)
Confirming your device's MFDS classification code and verifying eligibility for the 신고 pathway before any documentation work begins.
Technical Documentation & Registration
Authoring the Korean-language technical file to the exact format MFDS requires for Class I 신고 submissions, then managing the filing and any MFDS correspondence.
Korea License Holder (KLH)
Appointing Leanabl as the legally required KLH (importer of record), independent of your distribution arrangement, so the product license is held by a neutral regulatory partner — not your distributor.
The Fastest Class I Timeline Requires Getting the Scope Right — Not Just Moving Fast.
Correct Classification Before Authoring
We confirm your MFDS product code and 신고 pathway eligibility before a single document is written — eliminating the most common cause of Class I deficiency notices.
Independent KLH from Day One
Leanabl acts as your independent KLH (importer of record), holding the product license in our name on your behalf — so changes in your commercial relationships never affect the license held for your products.
Predictable Class I Outcomes for Foreign Manufacturers.
30-Day Class I Clearance for a European Diagnostics Firm
Confirmed product code, authored the Korean-language 신고 file, and secured MFDS Class I registration within 34 days for a European in-vitro diagnostics manufacturer entering Korea for the first time.
Multi-Product Class I Portfolio for a North American OEM
Executed simultaneous Class I 신고 filings for four product lines under a single KLH appointment, compressing what would have been sequential 6-month projects into a parallel 45-day program.
Your MFDS Class I Product Registration Certificate, Delivered Without Avoidable Delays.
Speed in Class I registration comes from scoping correctly and executing flawlessly — not from submitting quickly with the wrong documentation.
Speak with a Korea Registration Specialist TodayFrequently Asked Questions
Common questions answered.