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Labelling Requirements โ€” Korean Language Mandatory

A key Korean requirement: all medical device labelling must be in Korean (ํ•œ๊ตญ์–ด). Devices without Korean labels may not be supplied in Korea.

Mandatory label elementsโ€‹

  • Product name (Korean; English optional)
  • Manufacturer name and address
  • Importer name and address (for imported devices)
  • ํ’ˆ๋ชฉํ—ˆ๊ฐ€ / ํ’ˆ๋ชฉ์‹ ๊ณ  number
  • Lot / batch number or serial number
  • Manufacturing date and expiry date (where applicable)
  • Sterile indication (if applicable)
  • Single-use indication (if applicable)
  • UDI-K barcode / data matrix (for applicable devices)
  • Intended use / indication summary
  • Key warnings and contraindications

Bilingual labellingโ€‹

Bilingual (Korean + English) is permitted, but Korean must be present and equally prominent.

Relevant legislationโ€‹

  • Medical Devices Act, Article 24 ยท MFDS Notification โ€” Labelling Standards for Medical Devices