Language requirements by document type
The published rules do not state that every medical-device document must be translated into Arabic. The applicable requirement depends on the document type and regulatory pathway, such as marketing authorization, listing, importation, or advertising licensing. Technical documentation provided to the SFDA or a relevant party is in English and in Arabic when requested. Labels and Instructions for Use are subject to requirements for content, legibility, and suitability to the device. Advertising and marketing material is provided in Arabic and English under the guidance, while the intended audience also matters: material aimed at professionals is in English and material targeting ordinary users is in Arabic. In the advertising-licensing context, documents supporting advertising claims are in English. For an imported custom-made device, the label states that it is custom-made in Arabic and/or English. The published rules do not publish a general translator list, fee, uniform deadline, file limit, or acceptance guarantee for every service, so the language requirement must be tied to the current device-specific pathway.
- Medical-device marketing authorization application materials and linked requirements
- Technical documentation or technical files submitted to the SFDA or a relevant party
- Device labels and applicable packaging or sterile-packaging information
- Instructions for Use, including electronic-IFU references where the applicable requirement permits them
- Advertising and marketing material for medical devices and products
- Evidence documents supporting claims made in advertising
- Labels for imported custom-made medical devices, including the custom-made designation
Identify whether the document belongs to marketing authorization, listing, importation, advertising licensing, or another SFDA service.
Classify the document as technical documentation, a label, IFU, advertising material, claim evidence, or a custom-made-device import label.
Apply the category-specific language statement: English technical documentation with Arabic when requested; advertising and marketing language under the bilingual statement while accounting for the intended audience; and English claim evidence in the advertising-licensing context.
Check that the medium, format, content, legibility, and location suit the device, and that IFU accompany the device unless a justified and exceptional case applies.
Ensure promotional claims do not exceed the IFU and retain claim-supporting documents in the language required in the advertising-licensing context.
Submit through the applicable official service and respond to any SFDA request for Arabic or additional documentation under the current service instructions.
| Document type | Common use | Note |
|---|---|---|
Must every medical-device document be translated into Arabic?
No universal rule is established by the published rules. The applicable language depends on the document type, pathway, and any request from the SFDA.
What is the published language for technical documentation submitted to the SFDA?
The guidance says technical documentation is provided in English to the SFDA or relevant party, and in Arabic when requested.
Does that mean the technical file must always be bilingual?
No. The text supports English as the baseline, with Arabic when requested; it does not require every file to be permanently bilingual.
Must Instructions for Use accompany the device?
The guidance says IFU shall be provided with devices, subject to justified and exceptional cases where safe use is possible without them.
Does the IFU exception create a general translation exemption?
Not necessarily. It concerns whether IFU are needed, not a general exemption from translating required content.
What language is identified for advertising aimed at ordinary users?
The official material says advertising or marketing material targeting ordinary users is in Arabic.
What language is identified for advertising aimed at professionals?
The official material says material intended for professionals is in English.
Is there official support for providing advertising in both languages?
Yes. The guidance says advertising and marketing material shall be provided in Arabic and English. Read that together with the audience-specific rule.
May translated advertising go beyond the IFU?
No. The guidance says promotional material must not contain claims that exceed those in the IFU.
In what language are documents proving claims such as fastest or best provided?
In the advertising-licensing context, the official material says evidence documents are in English and must be valid and issued by accredited authorities.
What is the rule for a custom-made device label on import?
The applicable requirement for this category requires the label to state that it is custom-made in Arabic and/or English.
Does “labeling” include Instructions for Use?
Yes. The applicable checklist includes the label affixed to the device or its container or wrapper and the IFU.
Do the official materials identify an approved translation office or translator list?
No. The published rules do not publish a general translator or translation-office list for this topic.
Do the official materials set a fee, processing time, file limit, or acceptance guarantee?
No. The published rules do not establish a universal fee, time limit, file limit, or acceptance guarantee for all pathways.
What applies when the SFDA requests an Arabic version of technical documentation?
The requested Arabic version is prepared while the original, English version, and revision identifier are retained, followed by the current service instructions or SFDA request.
This guide is for general information and is not legal or consular advice. Always verify current requirements with the receiving authority.