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Labelling & IFU Requirements

SFDA labelling requirements​

Device labelling in Saudi Arabia must comply with the requirements in MDS-REQ 1 (labelling section) and any applicable SFDA labelling guidance. Key labelling requirements include:

  • Device name and intended use (or indication)
  • Legal manufacturer name and address
  • Authorized Representative name and contact details (must appear on label)
  • Lot/batch number, serial number, or UDI
  • Manufacturing date and expiry date (where applicable)
  • Sterile indication (where applicable)
  • Instructions for use reference (or abbreviated IFU on label)
  • Storage and handling conditions
  • Single-use symbol (where applicable)
  • CE marking is not required — but may appear if the device is also CE-marked

Language requirements​

Device typeLabel language
Professional use devicesEnglish is acceptable
Home-use (consumer/lay user) devicesArabic labelling is mandatory
Arabic labelling

Devices intended for use by lay persons (patients, home users) must have labelling and IFU in Arabic. Professional-use device labelling may be in English, but adding Arabic is good practice given the Saudi patient population.

Instructions for Use (IFU)​

The IFU must provide complete information for safe and effective use of the device, including:

  • Intended use and contraindications
  • Step-by-step operating instructions
  • Maintenance and cleaning instructions
  • Sterilisation or disinfection instructions (for reusable devices)
  • Storage and handling conditions
  • Warnings and precautions
  • Troubleshooting information
  • Manufacturer and AR contact details

UDI on labelling​

All devices must carry a UDI on the label in human-readable and, where appropriate, machine-readable (barcode or RFID) format. See UDI Labelling Requirements.

Advertising​

All promotional and advertising materials for medical devices require pre-approval from the SFDA under MDS-REQ 8. See Post-Market — Labelling & Advertising.

Further reading​