Your Korean License Holder Should Work for You — Not Your Distributor.
When your distributor is your KLH, they hold the license in their name.
In Korea, MFDS product licenses are held by the KLH (importer of record) — not by the foreign manufacturer. When your distributor serves as your KLH, the product license is registered in their name. Switching partners, adding channels, or resolving a dispute means the distributor controls the license transfer — a process that can take 6 to 12 months. Foreign manufacturers cannot hold Korean product licenses directly, so the choice of KLH is one of the most consequential regulatory decisions in a Korea market entry. Confusing the commercial role with the KLH role is the most costly mistake foreign medical device companies make in Korea.
An Independent License Holder That Gives You Full Commercial Control.
Leanabl serves as your independent domestic agent (국내 대리인) and importer of record, completely separate from your distribution network. The MFDS product license is held in Leanabl's name on your behalf — managed by a dedicated regulatory firm with no commercial interests in your Korea sales.
Distributor-Independent Holding
Leanabl holds the MFDS product license in our name as a neutral third party, giving you the freedom to appoint, change, or expand distributors without triggering any regulatory disruption.
Multi-Channel Commercial Flexibility
With Leanabl as your KLH, you can operate multiple distributors, direct sales channels, or e-commerce simultaneously — all under a single, stable importer of record with no competing commercial interests.
Ongoing MFDS Compliance Management
We manage annual quality reports, license renewal deadlines, change notifications, UDI registration updates, and all MFDS correspondence on your behalf, year-round.
What You Receive
As your registered domestic agent and importer of record, Leanabl maintains the MFDS product license and delivers structured compliance documentation on a regular cadence.
- MFDS Product License Certificate (held in Leanabl's name on your behalf)
- Annual Compliance Calendar with renewal deadlines and submission windows
- Annual Quality Report filed with MFDS on your behalf
- UDI Registration and ongoing update management
- Distributor Authorization Letters issued and revoked at your direction
The Right KLH Protects Your Korea Business — Regardless of Who Sells It.
Korean product licenses are held by the KLH (importer of record) in their own name — foreign manufacturers cannot hold them directly. When a distributor serves as the KLH, the product license sits in their name. The moment the commercial relationship sours, they control the exit. Leanabl's independent KLH structure ensures the license is held by a neutral regulatory partner with no commercial stake in your Korea sales — completely insulated from distributor disputes, contract terminations, or commercial renegotiations.
Speak with a KLH Specialist TodayFrequently Asked Questions
Common questions about the Korea License Holder service and how independent holding works under MFDS regulations.