South Korea is one of the fastest-growing medical device markets in Asia. To sell medical devices in the country, foreign manufacturers must comply with regulations established by the Ministry of Food and Drug Safety (MFDS).
One of the key regulatory requirements is appointing a Korea License Holder (KLH). The KLH acts as the official in-country representative responsible for submitting and maintaining medical device registrations.
If your company does not have a local legal entity in South Korea, appointing a qualified KLH is mandatory before starting the MFDS registration process.
This guide explains the Korea License Holder requirements, responsibilities, eligibility criteria, and how foreign manufacturers can appoint a KLH for MFDS medical device approval.
What is a Korea License Holder (KLH)?
A Korea License Holder (KLH) is a locally registered entity in South Korea that holds the medical device license and represents foreign manufacturers before the Ministry of Food and Drug Safety (MFDS).
The KLH is responsible for:
Submitting medical device applications
Communicating with regulatory authorities
Managing importation and compliance
Maintaining the device license throughout the product lifecycle
The KLH is also listed on the device labeling and acts as the legal license owner within South Korea.
Why Foreign Manufacturers Need a Korea License Holder
Foreign medical device manufacturers cannot directly submit product registrations to the MFDS without a local presence.
Therefore, appointing a Korea License Holder is mandatory for:
Importing medical devices into South Korea
Submitting regulatory applications
Managing post-market surveillance activities
Handling regulatory communications
This requirement applies to all medical device classes (Class I–IV) regardless of device risk classification.
Korea License Holder Requirements
To act as a Korea License Holder, the entity must meet specific regulatory requirements defined by the MFDS.
1. Local Business Registration
The KLH must:
Be legally established in South Korea
Maintain a registered business address
Hold a valid business registration certificate.
2. Import License
The KLH must obtain a medical device import business license to import and distribute medical devices in South Korea.
3. Appointed Quality Manager
The organization must employ a certified Quality Manager responsible for regulatory compliance and quality management.
4. MFDS Registration
The KLH must be officially registered with the Ministry of Food and Drug Safety as a licensed medical device importer and regulatory representative.
5. Compliance with KGMP
The KLH must ensure compliance with Korea Good Manufacturing Practice (KGMP) requirements for applicable device classes.
Responsibilities of a Korea License Holder
The Korea License Holder performs several regulatory and compliance responsibilities throughout the product lifecycle.
Regulatory Submission
Submit medical device applications to MFDS
Maintain technical documentation
Respond to regulatory queries
Importation Management
The KLH is responsible for importing the medical devices into South Korea and ensuring they meet regulatory requirements.
Quality Control
The KLH must verify product quality and release imported devices to the market after regulatory checks.
Post-Market Surveillance
Responsibilities include:
Monitoring product safety
Reporting adverse events
Managing product recalls if required.
License Maintenance
The KLH must maintain regulatory approvals and submit updates when:
Product changes occur
Manufacturing sites change
Documentation is updated.
Who Can Act as a Korea License Holder?
Foreign manufacturers typically choose one of the following options:
Distributor as KLH
Many manufacturers appoint their local distributor to act as the license holder.
Pros
Faster market entry
Existing distribution network
Cons
Distributor owns the license
Difficult to change partners later
Independent Regulatory Consultant
A third-party regulatory company acts as KLH while manufacturers retain distributor flexibility.
Korean Subsidiary
Large companies sometimes establish a local Korean subsidiary and register it as the KLH.
Steps to Appoint a Korea License Holder
Foreign manufacturers typically follow these steps:
Identify a qualified Korean entity
Sign a KLH agreement
Transfer regulatory documentation
Register the KLH with the MFDS
Submit medical device registration
Obtain approval and begin importation
Risks of Choosing the Wrong KLH
Selecting the wrong KLH can create regulatory and commercial risks.
Common challenges include:
Loss of control over product license
Distributor conflicts
Difficult license transfer
Regulatory delays.
Because the KLH legally holds the device license in Korea, changing the KLH later may require a license transfer or new registration.
How Long Does MFDS Approval Take?
The timeline for medical device approval depends on the device classification.
Typical timelines include:
Device Class | Typical Timeline |
Class I | 1–2 months |
Class II | 4–6 months |
Class III | 6–12 months |
Class IV | Up to 12–16 months |
Key Documents Required for KLH Registration
Foreign manufacturers must provide documentation including:
Free Sale Certificate
Technical Documentation
Device Description
Labeling and Instructions for Use
Risk Management File
Clinical Evidence (if required)
All regulatory submissions must generally be translated into Korean.
How OMC Medical Can Support as Korea License Holder
OMC Medical provides comprehensive support for medical device market entry in South Korea, including:
Korea License Holder services
KGMP compliance support
Technical documentation preparation
Our regulatory experts help manufacturers navigate the MFDS approval process efficiently and ensure compliance with Korean medical device regulations.
Conclusion
Appointing a Korea License Holder (KLH) is a critical step for foreign manufacturers seeking access to the South Korean medical device market. The KLH serves as the regulatory representative responsible for device registration, importation, and ongoing compliance with MFDS regulations.
Selecting the right KLH partner can significantly impact the success of your market entry strategy in South Korea.
Frequently asked Questions
What is the role of a Korea License Holder in MFDS medical device registration?
A Korea License Holder (KLH) is a local entity authorized to submit medical device registration applications to the Ministry of Food and Drug Safety (MFDS) on behalf of foreign manufacturers. The KLH manages regulatory communication, importation, and ongoing compliance for medical devices in South Korea.
Can foreign manufacturers register medical devices in South Korea without a Korea License Holder?
No. Foreign manufacturers cannot directly register medical devices with the MFDS without a local entity. They must appoint a Korea License Holder who will submit applications, hold the device license, and manage regulatory responsibilities within South Korea.
Does the Korea License Holder own the medical device license in South Korea?
Yes. In most cases, the Korea License Holder is listed as the legal license holder for the medical device in South Korea. This means the KLH manages the regulatory approval and maintains the device registration with the MFDS.
What qualifications are required to become a Korea License Holder?
To act as a Korea License Holder, a company must be legally established in South Korea, hold a medical device import business license, and appoint a qualified quality manager responsible for regulatory compliance and communication with the MFDS.
How do foreign manufacturers appoint a Korea License Holder?
Foreign manufacturers appoint a Korea License Holder by selecting a qualified Korean entity and signing a regulatory representation agreement. The KLH then submits medical device registration documents to the MFDS and manages the approval process on behalf of the manufacturer.
Can a Korea License Holder transfer a medical device license to another company?
Yes, but the transfer process must be approved by the MFDS. The new Korea License Holder must meet all regulatory requirements and submit the necessary documentation to update the license ownership.
Can a Korea License Holder represent multiple foreign manufacturers?
Yes. A qualified Korea License Holder can act as the regulatory representative for multiple foreign manufacturers, provided they maintain proper documentation and regulatory compliance for each manufacturer’s devices.
What happens if the Korea License Holder stops operating or loses its license?
If the Korea License Holder ceases operations or loses its regulatory authorization, the medical device license may become invalid until a new KLH is appointed and approved by the MFDS. Manufacturers must quickly arrange a license transfer or new registration to continue selling the device in South Korea.
