Korea License Holder (KLH)

Accessing the Korean Market

Foreign manufacturers intending to place medical devices or in vitro diagnostic devices on the South Korean market are required to appoint a Korea License Holder (KLH).

The KLH acts as the official legal representative before the Ministry of Food and Drug Safety (MFDS), managing product registration and ensuring compliance with Korean regulatory requirements, including Korea Good Manufacturing Practice (KGMP).

Role of the Korea License Holder

The Korea License Holder plays a central role in the regulatory process and is formally identified on the MFDS product approval certificate.

Key responsibilities include:

• Submission and maintenance of product registrations
• Coordination of KGMP certification and audits
• Management of importation compliance and customs clearance
• Post-market surveillance and incident reporting
• Acting as the primary point of contact with MFDS

The KLH must operate as a licensed importer and is responsible for ensuring that products placed on the Korean market remain compliant throughout their lifecycle.

Independent License Holder Model

In many cases, the Korea License Holder is also the distributor. While this may seem convenient, it can create significant limitations for manufacturers.

The registration is held by the KLH and does not expire, meaning that control over the product registration remains with that entity.

This can create challenges when:

• Changing distributors
• Expanding to multiple distribution partners
• Managing long-term commercial strategy

An independent Korea License Holder model allows manufacturers to retain full control over their registrations, intellectual property, and distribution strategy.

Our Services

ALTRION provides independent Korea License Holder services, ensuring flexibility, transparency, and long-term regulatory control.

KLH Appointment & Registration

• Formal appointment as Korea License Holder
• Submission of MFDS product registration applications

KGMP Support

• Preparation and submission of KGMP certification applications
• Support during on-site audits

Regulatory Coordination

• Direct communication with MFDS
• Management of regulatory requests and updates

Importation & Distribution Support

• Coordination with distributors for compliant importation
• Support for multi-distributor structures

Post-Market Activities

• Incident reporting and vigilance coordination
• Ongoing regulatory compliance monitoring

Identical Product Registration

• Support for identical product registration processes
• Enabling multiple distributors to import products under the same approval

Strategic Advantages

By working with an independent Korea License Holder, manufacturers can:

• Maintain control over product registrations
• Avoid dependency on a single distributor
• Expand or change distribution networks without regulatory disruption
• Ensure consistent regulatory oversight

Our Approach

We act as a reliable regulatory partner in Korea, combining local presence with international regulatory expertise.

Our approach ensures that manufacturers maintain full control of their market strategy while meeting all MFDS requirements in a structured and efficient way.