Your Distributor Is Your KLH. That Means the Product License Is in Their Name.
In Korea, foreign manufacturers cannot hold product licenses directly. The KLH (importer of record) holds the license under their own name. When your distributor is your KLH, they control the license — and they control what happens to it when the relationship ends.
Appoint an Independent KLH Before You Need One.
Leanabl accepts appointment as your Korea License Holder (importer of record), holding the product license in Leanabl's name on your behalf — as a neutral regulatory entity with no commercial interests in your Korea sales.
Independent License Holding
Leanabl's licensed domestic entity assumes the KLH role for your MFDS-registered products, holding the license in our name entirely separate from your distribution arrangement, so that any change in distribution does not affect the license held for your products.
Regulatory Obligation Management
Fulfilling all MFDS-required KLH functions — receiving and forwarding regulatory correspondence, coordinating required labeling updates, and supporting adverse event reporting as mandated by Korean vigilance regulations.
License Continuity Assurance
Maintaining active KLH status across product renewals, change notifications, and MFDS correspondence cycles — so that your license never lapses due to administrative gaps in the KLH function.
The Time to Appoint an Independent KLH Is Before Your Distribution Relationship Becomes Adversarial.
Complete Commercial Separation
Leanabl has no sales or distribution role for your product. You retain full commercial control over how your device is sold, distributed, and priced in Korea — while we hold the regulatory license independently.
Proactive Structure, Not Reactive Recovery
Manufacturers who appoint Leanabl before any conflict arises can change distributors, add distributors, or restructure their Korea commercial arrangement at any time — without any involvement from the entity holding their license.
License Independence Secured for Manufacturers Across Multiple Device Categories.
KLH Transfer from Distributor During Commercial Dispute
Managed a complete MFDS KLH transfer for a European orthopedic manufacturer whose distributor was refusing to cooperate — securing the license within the statutory process period without commercial interruption.
Multi-Product KLH Appointment for a New Korea Market Entrant
Appointed Leanabl as independent KLH for five registered product lines simultaneously for a North American manufacturer, structuring full license independence from day one of Korea market entry.
Active KLH Appointment — License Independence, Ongoing.
KLH independence is not a problem you solve reactively — it is a structure you put in place proactively.
Appoint Leanabl as Your Independent KLH TodayFrequently Asked Questions
Common questions answered.