Question 1

Our current distributor is already our KLH. Why would we change?

Accepted Answer

When your distributor serves as the KLH, the MFDS product license is held in their name. If the relationship ends, they control the license transfer timeline and can delay or withhold cooperation — leaving you unable to sell in Korea during the transition. Migrating to an independent KLH like Leanabl moves the license into a neutral entity's name, eliminating this dependency entirely.

Question 2

How does the engagement scale across multiple licenses and distributors?

Accepted Answer

The KLH function is structured per MFDS license — each license is held independently under Leanabl's name, with the compliance calendar, Annual Quality Report, renewal scheduling, and UDI maintenance managed per license across your portfolio. Distributors are a separate dimension: authorization letters are issued and revoked at your direction as one-time setup actions, and your distribution arrangements do not affect the underlying regulatory function. You can add licenses or rotate channel partners without restructuring the KLH engagement.

Question 3

How long does it take to transfer an existing MFDS license to Leanabl?

Accepted Answer

A domestic agent change is filed with MFDS and typically takes 4 to 8 weeks to process. There is no interruption to your product's market authorization during the transfer. Leanabl handles all filing paperwork and MFDS correspondence.

Question 4

Does the KLH also handle import customs clearance?

Accepted Answer

No. The Korea License Holder role is a regulatory function under MFDS — it does not cover customs brokerage, import logistics, or product distribution. Your existing distributor or a licensed customs broker handles those functions independently.

Question 5

What is Leanabl's liability as the registered domestic agent?

Accepted Answer

As your domestic agent and importer of record, Leanabl bears regulatory liability to MFDS for filing accuracy, timely reporting, and compliance with Korean medical device law. This is governed by a clearly defined service agreement reviewed in detail before engagement begins.

Korea License Holder

When your distributor is your KLH, they hold the license in their name.

Distributor-Independent Holding

Multi-Channel Commercial Flexibility

Ongoing MFDS Compliance Management

Service specification

Korea Korea License Holder

Frequently Asked Questions