Insights / Life Sciences

SFDA Arabic Labeling: What Medical Device Makers Must Translate

Which parts of a medical device label and IFU must be in Arabic for the Saudi market, what the SFDA texts say, and a checklist to prepare your file.

Quick Answer

SFDA Arabic labeling rules require Arabic and English information for medical devices used by lay persons and for self-testing IVDs. That covers the instructions for use, the electronic user interface, the Arabic rendering of the device name and promotional material. Devices for healthcare professionals must be understood by their users, and SFDA can request service documents in Arabic.

What Does SFDA Arabic Labeling Require for Medical Devices?

SFDA Arabic labeling requires that information supplied with devices for lay persons be in both Arabic and English. The main source is the SFDA document Requirements for Medical Devices Marketing Authorization (MDS-REQ 1), version 6.0, dated December 19, 2021. Its Annex 1 sets the Essential Principles that a Medical Device Marketing Authorization (MDMA) file must meet.

For devices other than IVDs:

Information supplied by the manufacturer: for devices used by lay persons, it “shall be in both the Arabic and English languages” (Essential Principle 23.1(a)).
Electronic user interface: for lay-person devices, the interface of the electronic system must be in Arabic and English (Essential Principle 22.1).
Device name on the label: the label must show the name or trade name, plus the “Arabic name as it is pronounced in English” for lay-person devices (Essential Principle 23.2(a)). This points to a phonetic rendering in Arabic script, not a new translated brand.
IFU content for lay users: the IFU must state when the user should consult a healthcare professional and give contact details for technical assistance centers inside Saudi Arabia (Essential Principle 23.4(w) and (cc)).

For self-testing IVDs, the information supplied, the electronic interface and the Arabic device name follow the same bilingual rule (Essential Principles 19.1, 20.1(a) and 20.2(a)).

Which Content Must be in Arabic, and Which Can Stay in English?

The Arabic requirement in MDS-REQ 1 targets lay users, so audience decides most of the answer. For professional-use devices, IFUs must be “written in terms readily understood by the intended user,” and the bilingual rule is not repeated. Three rules reach beyond the label:

Promotional material: for lay-person devices, advertising and marketing material must be in Arabic and English (Annex 3, section 2(d)).
Service documents: instructions for handling, storage, transport, installation, maintenance (including service manuals) and disposal must be available to SFDA or any relevant party in English and, when requested, in Arabic (Annex 3, section 2(e)).
Implant patient information: information for patients with an implanted device must be stated in Arabic and English and written so a lay person can understand it (Annex 8).

Trade guidance points the same way. The US Commercial Service Saudi Arabia labeling and marking page (May 2026) states that warnings and safety instructions must be in Arabic, or Arabic and English, and that instruction manuals must be in Arabic or both languages. It refers device exporters to the SFDA Medical Device Department for full rules.

How Do Device-Specific SFDA Guidances Add Detail?

Device-specific guidances can name exactly which items need Arabic. A clear example is MDS-G-014, Guidance on Content of Labeling of Contact Lenses and its Solutions, version 3.0, dated October 1, 2024.

It requires labeling written in English. When the product is intended for a lay person, it also requires Arabic for:

The IFUs of the contact lenses and solutions, “completely and clearly.”
The label on contact lens solutions.
The label on contact lenses, at least the purpose, lens type, wear schedule and replacement frequency.

The product name must also appear in English and in Arabic “as it is pronounced in English.” And the translated labeling must be approved by the manufacturer and kept in the technical documentation. That makes the manufacturer accountable for the Arabic text, so you need a review step and a record of it.

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Can you Use Electronic IFUs (eIFU) in Saudi Arabia?

Yes, MDS-REQ 1 allows electronic IFUs that meet Annex 10, which requires:

A documented risk assessment covering users, environment and internet access.
A release date, target jurisdiction and version control.
Access without an online account or password.
Clear identification of the IFU approved for the Saudi market.
Availability for at least 2 years after the expiry date of the last device produced. For implants and devices without an expiry date, the period is 15 years after the last device is made.

For IVDs, eIFU is limited to professional-use devices and excludes near-patient testing (Essential Principle 20.1(f)). Labeling must not include the SFDA logo, though it may show the Medical Device National Listing Number (Essential Principle 23.1(i)).

SFDA Arabic Labeling Checklist

Use this table to check your file before submission.

Item	Arabic needed?	Source
Information supplied with lay-person devices (label and IFU)	Yes, Arabic and English	MDS-REQ 1, EP 23.1(a)
Electronic user interface, lay-person devices	Yes, Arabic and English	MDS-REQ 1, EP 22.1
Device name on label, lay-person devices	Arabic name as pronounced in English	MDS-REQ 1, EP 23.2(a)
Self-testing IVD information and interface	Yes, Arabic and English	MDS-REQ 1, EP 19.1, 20.1(a)
Promotional material, lay-person devices	Yes, Arabic and English	MDS-REQ 1, Annex 3
Service, storage and disposal instructions	English; Arabic on request	MDS-REQ 1, Annex 3
Implant patient information	Yes, Arabic and English	MDS-REQ 1, Annex 8
Contact lens IFU and labels, lay use	Yes, as listed in the guidance	MDS-G-014 v3.0
Manufacturer approval of translated labeling	Required, kept in technical file	MDS-G-014 v3.0
Saudi-market eIFU	Must be clearly identified	MDS-REQ 1, Annex 10

How Should you Prepare an Arabic Label and IFU Package?

Start from a locked English source, then translate, review and file the Arabic as a controlled document. A practical sequence:

Classify the audience. Lay-person, self-testing or professional use sets the Arabic scope.
Freeze the English source. A moving draft creates mismatches between label, IFU and interface strings.
Build a terminology list. Agree on Arabic terms for anatomy, warnings and device parts first.
Translate into Modern Standard Arabic. Use written regulatory Arabic and check that consumer terms read naturally for Gulf users.
Render the trade name phonetically. Prepare the Arabic name as pronounced in English and keep it consistent across label, IFU and interface.
Review. A second qualified linguist checks meaning, warnings and units; your regulatory team signs off.
Check layout. Arabic runs right to left, so verify mixed-language panels, symbols and numbers in final artwork.
File the record. Store the approved translation and its approval in the technical documentation.

Requirements change, so confirm current SFDA labeling rules with the SFDA or qualified regulatory counsel before you submit. This article is informational only and is not regulatory advice.

What About Other Gulf Markets?

Other Gulf markets also expect Arabic on labels, though device rules come from each health regulator. US Commercial Service guides state general labeling rules:

United Arab Emirates: labels must be in Arabic only or Arabic and English, and Arabic stickers are accepted (trade.gov, August 2025).
Bahrain: labels must be in Arabic or in both Arabic and English (trade.gov, December 2025).
Oman: labels must be in Arabic only or Arabic and English, with some English-only labels approved in exceptional cases (trade.gov, December 2025).

These pages cover goods broadly, so check each health regulator’s device rules before reusing a Saudi IFU.

Frequently Asked Questions

Does Every Medical Device Sold in Saudi Arabia Need an Arabic IFU?

Not under MDS-REQ 1 alone. The bilingual rule applies to lay-person devices and self-testing IVDs. Professional-use IFUs must be readily understood by the intended user, and service documents must be available in Arabic on request.

What Does the Arabic Name Rule Mean?

SFDA asks for the device name in Arabic “as it is pronounced in English,” in both MDS-REQ 1 and MDS-G-014. That is the trade name written in Arabic script so it sounds like the English name. Keep the same rendering on every label, IFU and screen.

Can we Supply the Arabic IFU Only Online?

MDS-REQ 1 allows eIFU when Annex 10 conditions are met, including a risk assessment and version control. The Saudi-market IFU must be clearly identified and open without an account or password.

Who is Responsible for the Accuracy of the Arabic Translation?

The manufacturer. MDS-G-014 states that translated labeling must be approved by the manufacturer and kept in its technical documentation. Record who translated, reviewed and approved each version.

How Afrasia Trans Can Help

Afrasia Trans provides Arabic translation and multilingual DTP solutions for medical device labels, IFUs, eIFUs and software interfaces. Our linguists work by dialect and market, so written content follows Modern Standard Arabic while lay terminology is checked for Gulf readers. We can build your terminology list, translate and review label and IFU text, and lay out right-to-left artwork. See our life sciences and medical device solutions and the full list of languages we cover. Ready to prepare your SFDA file? Contact us for a quote.

About the Author

Mohamed Salah

Mohamed Salah writes the Afrasia Trans industry guides on media, gaming, AI data, life sciences, legal and travel localization.

Sources

This article is for general information only. It is not legal, regulatory or medical advice.

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