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Korean Agent Obligations for Foreign Manufacturers

Foreign manufacturers without a Korean legal entity must appoint a Korean agent (한국 대리인) — typically the entity holding the importer licence (수입업 허가) — to serve as their regulatory representative and intermediary with MFDS for all submissions and communications.

Korean agent responsibilities​

  • Hold the 품목허가 / 품목신고 for the foreign manufacturer's products
  • Ensure the foreign manufacturer maintains a valid GMP certificate recognised by MFDS
  • Submit regulatory applications and change notifications to MFDS
  • Act as the primary contact point and liaison with MFDS for adverse event reporting, post-market surveillance communications, and product recalls
  • Apply Korean-language labelling to imported products
  • Maintain distribution records for traceability

Obligations that remain with the foreign manufacturer​

  • Providing accurate and complete technical documentation
  • Maintaining GMP compliance at the manufacturing site
  • Cooperating with adverse event investigations
  • Providing safety information for FSNs and recalls

Written agreement​

A formal written agreement between the foreign manufacturer and the Korean agent documenting respective responsibilities is expected by MFDS.

Appointment and Registration Process​

The Korean agent must be formally appointed and this relationship should be documented in MFDS submissions. Key steps include:

  • Establish a written agreement with the foreign manufacturer clearly delineating responsibilities
  • Ensure the Korean agent is registered as an importer or distributor with MFDS if not already holding a business licence
  • Include the Korean agent's contact details and qualifications in the 품목허가/품목신고 application
  • Update MFDS if the Korean agent changes during the product's market life