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Third Party License Holder and In-Country Representative for South Korea

See all In-Country Representation services.

Companies without a physical location in South Korea must appoint a Third Party License Holder to coordinate the registration of their medical device with the Korea Food and Drug Administration (KFDA). The License Holder also controls the device registration and can help to ensure compliance with Korea Good Manufacturing Practice (KGMP) requirements.

Contact Emergo Group for more information about Korea Third Party License Holder representative

Responsibilities of the Third Party License Holder in Korea

The Korean License Holder has substantial responsibilities in Korea, much more than the equivalent role in the United States or Europe. Among other tasks, the License Holder can:

  • Assist in the preparation of the Technical File
  • Coordinate and submit the Technical File to the KFDA
  • Clear all incoming product shipments through Korean Customs
  • Coordinate Incident Reporting within Korea
  • Act as the primary liaison with the KFDA

Benefits of independent representation in South Korea

Many companies elect to have a distributor coordinate their medical device registration in Korea and appoint their distributor as their Third Party License Holder. Unfortunately, many non-Korean manufacturers do not realize that if the distributor is appointed as the Third Party License Holder, the distributor controls the medical device registration with the KFDA. This becomes a problem if the manufacturer wants to switch distributors at a later time.

Emergo Group offers independent Third Party License Holder services, allowing you the freedom to select and switch distributors as needed.

Please note that we cannot currently assist with IVD registration in South Korea and therefore cannot act as a TPLH for IVD manufacturers.

Please contact us for more information of a free proposal on our Third Party License Holder representation services for Korea.

Questions? Call or email us.+1 512 327 9997See list of all offices.

Learn more about Korea

Regulatory Chart - KoreaDownload PDF chart that explains the medical device approval process in KoreaDownload copies of device regulations in Korea