South Korea Authorized Representative (AR)

Foreign manufacturers must appoint a local authorized representative, also known as a Korea License Holder (KLH), who interacts with the regulatory authorities on the manufacturer’s behalf. The KLH holds and renews the medical device license issued by the Ministry of Food and Drug Safety (MFDS), coordinates product registration with the MFDS and helps to manage compliance with Korea Good Manufacturing Practice (KGMP) requirements.

South Korea allows two KLHs for one medical device under certain conditions; this requires formal agreement and re-registration. KLHs must comply with some requirements, including being established officially in the territory of South Korea. Further requirements are:

• The employment of a certified Quality Manager,
• Possession of an Import Business License,
• Being an ICC - ICC-in-country caretaker, which is a mandatory legal representative for foreign medical manufacturers operating in South Korea without a local entity.  

Liaison with the MFDS

The KLH serves as your official point of contact with the MFDS. This includes managing all regulatory communications, responding to inquiries, and facilitating audits. Delays and regulatory risks can be prevented by maintaining a proactive and transparent relationship with the authority.

Importation chekcs, quality controls and reporting

Your KLH oversees all importation activities to ensure that medical devices entering South Korea meet approved specifications and regulatory standards. This includes verifying shipment documentation, conducting or coordinating quality inspections, and ensuring proper traceability.

In addition, the KLH is responsible for maintaining post-market quality oversight. Any deviations, complaints, or adverse events must be documented and reported in accordance with MFDS requirements, ensuring that your products remain compliant throughout their lifecycle.

Preparation of documentation according to the MFDS

South Korea has highly specific documentation standards for medical device registration and maintenance. Your KLH is responsible for preparing, reviewing, and submitting all required documentation in full compliance with MFDS guidelines.

This includes technical files, product registrations, and any amendments required during the product lifecycle. The KLH also enforces Korean labelling requirements and maintains the Device Master Record (DMR).

Compliance & market surveillance

Ongoing compliance does not end with product approval. The KLH is responsible for submitting mandatory annual reports to the MFDS, including updates on product status, distribution, and safety performance. They also play a key role in market surveillance activities; by monitoring product performance in the field, managing recalls if necessary, and ensuring that any safety concerns are promptly addressed and reported. All in all, they facilitate market access by maintaining regulatory compliance with the Medical Device Regulations in South Korea.