Entering the Saudi market requires SFDA (Saudi Food and Drug Authority) registration for all medical devices. The process can take 6-18 months depending on device class and documentation readiness.

Device classification

SFDA classifies devices into Class A (low risk) through Class D (high risk). Higher classes require clinical evidence and stricter scrutiny.

Required documents

  • ISO 13485 certificate
  • CE mark or FDA 510(k) (where applicable)
  • Technical file / Design dossier
  • Arabic labelling compliant with SFDA guidelines
  • Authorised local representative letter

Timeline expectations

Class A devices can be registered in 3-6 months. Class C/D devices routinely take 12-18 months. Engaging an experienced local representative significantly reduces back-and-forth.