CE and FDA Approval Do Not Transfer to Korea. Build the Right File or Face Deficiency Cycles.
MFDS requires a Korean-language STED built to Korea-specific content and formatting requirements — it is not a translation of your CE file. Each deficiency cycle adds 3 to 6 months to an already 12-to-18-month base timeline.
Turn-Key MFDS Product Registration, Built on Korea-Specific Expertise.
We take responsibility for every step from pathway confirmation through MFDS approval.
Regulatory Pathway Strategy
Confirming MFDS product classification, identifying predicate devices in the Korean market, and defining the exact documentation and testing requirements before any authoring begins.
Technical Documentation & Registration
Authoring the Korean-language STED to MFDS standards, translating and adapting labeling, managing MFDS submission, and executing full deficiency response on your behalf.
Korea License Holder (KLH)
Appointing Leanabl as your independent KLH (importer of record). In Korea, the product license is held in the KLH's name — foreign manufacturers cannot hold it directly. Leanabl holds the license as a neutral regulatory partner, ensuring it is never subject to distributor leverage or commercial disputes.
A Deficiency Cycle Is Not a Minor Delay — It Is a 3-to-6-Month Commercial Setback.
Korea-Specific STED Authoring
We restructure and adapt your existing documentation rather than translate it — building a Korean STED that satisfies MFDS requirements for your specific product classification and device category.
Test Report Coordination
We coordinate Korean test reports with NIFDS-recognized laboratories where required, preventing the single most common deficiency trigger in Class II and III MFDS submissions.
MFDS Approvals Delivered for Class II and Class III Devices.
Class III Approval for a North American Cardiovascular Device Manufacturer
Authored the Korean STED, coordinated NIFDS test reporting, and managed full MFDS deficiency response for a Class III cardiovascular implant — achieving approval within 16 months from engagement start.
Class II Registration for a European Diagnostic Imaging Company
Confirmed MFDS product classification, identified Korean predicate devices, and delivered a deficiency-free STED that passed MFDS review in the first cycle for a Class II imaging system.
Your MFDS-Issued Medical Device Product Approval Certificate.
Our files are built to pass MFDS review — not to generate deficiency correspondence.
Speak with a Registration Project Lead TodayFrequently Asked Questions
Common questions answered.