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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