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 for Saudi registration — it must not appear on labelling intended for the Saudi market unless the device is concurrently CE-marked for EU distribution, in which case separate labelling for each market is recommended to avoid regulatory confusion
Language requirements
| Device type | Label language |
|---|---|
| Professional use devices | English is acceptable |
| Home-use (consumer/lay user) devices | Arabic labelling is mandatory |
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. However, adding Arabic translation is recommended, particularly if the device may be used by healthcare workers whose primary language is Arabic, or in settings where dual-language labelling improves safety and compliance.
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
- MDS-REQ 1 — Labelling requirements
- MDS-REQ 8 — Medical Device Advertising
- UDI Overview
- Post-Market Labelling & Advertising
While English is acceptable for professional-use devices, manufacturers should consider providing Arabic translations on labels even for professional devices, as many healthcare professionals in Saudi Arabia may benefit from bilingual labelling. This supports compliance with good manufacturing practice and user safety principles.
Prohibited markings
Device labels must not carry: CE marking (unless the device is also CE-marked for concurrent EU distribution) Misleading symbols or claims about performance or safety not supported by clinical evidence False indication of regulatory approval in other jurisdictions Any marking that could confuse users about the device's actual regulatory status in Saudi Arabia