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Import Labelling Rules

Importer label requirements​

The Korean importer must ensure imported devices carry:

  • Importer's name and address in Korean
  • Importer's 수입업체 (or 수입업자) registration / import license number number
  • Korean-language translation of all labelling and IFU content

Sticker labelling​

Permitted to apply a Korean-language sticker (부착 라벨) alongside original foreign-language labelling, provided:

  • The sticker includes all mandatory Korean label elements
  • It does not obscure safety-critical original label information
  • Applied before the device enters the Korean supply chain

"Safety-critical information includes warnings, contraindications, shelf life, storage conditions, sterilization method (if applicable), single-use indicators, and UDI-K barcode. Stickers must not overlap or obscure these elements."