Korean License Holder (KLH) for Medical Device registration in South Korea

Your Path to Market Entry Excellence in South Korea Starts with Freyr!

Foreign manufacturers aiming to market their devices in South Korea must appoint a Korean License Holder (KLH). Freyr acts as your KLH and ensures a seamless entry into the South Korean market.

Medical Device Registration in Japan Overview

Medical devices in South Korea are regulated by the Ministry of Food and Drugs Safety (MFDS), formerly known as the Korean Food and Drug Administration (KFDA). MFDS requires all foreign manufacturers wishing to market their devices in South Korea to appoint a Korean License Holder (KLH) to register their devices with the MFDS.

Freyr KLH Competencies

  •  
    Local Agent Representation in South Korea.
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     Liaison with the MFDS.
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     Preparation of Documentation according to the MFDS.
  •  
     Post Market Surveillance Activities.
  •  
    Translation Support.
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     License Renewal.
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    Regulatory Advisor.
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    Reimbursement Management Importation.
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    End-to-end Registration Support.

Frequently Asked Questions (FAQs)

A KLH is an entity with an established place of business in Korea responsible for placing the device on the Korean market on behalf of the foreign manufacturer. The KLH is the owner of the product license and is required for all risk classes of medical devices and in-vitro diagnostic (IVD) devices.

As the KLH oversees the foreign manufacturer’s device in South Korea, MFDS expects the KLH to ulfil the following prerequisites:

  • A KLH must be a resident of South Korea.
  • A KLH must have a registered office in South Korea with a business license.
  • A KLH must register with the MFDS as an authorized KLH with a medical device import license.
  • A KLH must register a quality manager in compliance with MFDS requirements.

Appointing a reliable KLH is a critical pre-requisite for registering the device with MFDS, South Korea. Foreign manufacturers must diligently evaluate the possible options for appointing a KLH. The manufacturer can:

  • Appoint a distributor as KLH.
  • Appoint an independent entity as a KLH.
  • Set up a subsidiary in South Korea and register as a KLH.
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Medical Device Regulatory Consulting – Proven Expertise

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Countries
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Global Customers
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In-house Regulatory Experts
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In-country Regulatory Affiliates
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Why Freyr?

  • Independent representation and Regulatory support.
  • Continuous liaison with the agency for submissions, queries, and feedback.
  • Single point of contact in the country for liaison with Regulatory agency.