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Who Needs to Comply?

Manufacturers (제조업자)​

Must hold: manufacturer licence (제조업 허가), KGMP certification, 품목허가/신고 per product, UDI-K/KIMS registration.

Foreign Manufacturers​

Do not need a Korean manufacturer licence but must:

  • Appoint a Korean agent (한국 대리인) — typically the Korean importer
  • Obtain a Foreign GMP Certificate (해외제조소 인증) recognised by MFDS

Importers (수입업자)​

Must hold: importer licence (수입업 허가), 품목허가/신고 for each imported product, ensure valid foreign GMP certificate, apply Korean-language labels.

Distributors & Retail Dealers​

Must register with MFDS before distributing. Must store devices properly and report adverse events.

Repair Business Operators​

Must register as a repair business (수리업).

Under 'Foreign Manufacturers' section, expand the Korean agent definition: 'The Korean agent must be a legal entity established in Korea (such as the importer or a designated representative) and is responsible for communicating with MFDS, maintaining technical documentation in Korean, and ensuring regulatory compliance on behalf of the foreign manufacturer.'