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Electronic IFU (eIFU)

MFDS has introduced provisions allowing electronic IFU (eIFU) for certain device types.

When eIFU is permitted​

  • Devices intended for professional use only (not home/consumer use)
  • eIFU accessible via QR code, URL, or integrated display
  • User has confirmed internet/digital access

When eIFU is NOT permitted as sole IFU​

  • Devices intended for patient/lay user home use
  • Devices used in emergencies where internet access may not be available

eIFU requirements​

  • Freely accessible — no subscription or login required
  • URL/QR code printed on device or packaging
  • Available for the entire commercial life of the device
  • MFDS must be able to access for inspection purposes

"Language and accessibility

eIFU must be in Korean or a language approved by MFDS. The URL or QR code link must remain functional and accessible without requiring users to create accounts, pay fees, or provide personal data beyond what is necessary for security purposes."