Arabic Labeling and IFU Requirements in Saudi Arabia: Language Rules by User Type

1. Key takeaways

The Arabic requirement in Saudi Arabia is not mandatory throughout. It is layered by user type: instructions for use and advertising directed at lay users must be provided in Arabic, while those for professional users may be in English or Arabic. Electronic instructions for use follow MDS-REQ 1 Annex (10). The definition of Identifying Information (Labeling) in Annex 1 of MDS-G028 marks out what must appear on the label: the device name, the code, lot or batch number or serial number, the technical description, the method of use, and the storage and transport conditions. MDS-G030 also lists labels, instructions for use, and user interfaces among the Saudi-specific applicable requirements, so reliance-pathway products receive no waiver at this layer either.

• The trigger for the Arabic requirement is the type of user, not the type of device.
• Lay-user IFUs and advertising must be in Arabic; professional-user materials may be English or Arabic.
• Borderline products like glucose meters and home nebulizers default to the strictest reading if the IFU does not restrict the user.
• Five label identification items form the minimum label set and stack on top of UDI obligations, not instead of them.
• Procedure pack labeling duties descend to component level, alongside the component list letter and consent letters.
• Under MDS-G030 item 3, label, IFU, and user-interface language remain Saudi-specific requirements even on the reliance pathway.

2. Legal basis

The table below maps the instruments governing language and labeling, their document numbers and dates, the relevant clauses, and the key points of the original text. Regulatory information verified as of October 29, 2026.

3. Expert insights

The decision point of the layering is who the user is, not what the product is. The variable that triggers the language requirement is the type of user, not the type of device. Two devices from one company, one for home self-testing and one operated only by laboratory professionals, fall on different sides: the former must have an Arabic IFU and Arabic advertising, the latter may use English.

Where this layering most often goes wrong is at the borderline products: glucose meters, home nebulizers, and contact lens care solutions entering household as well as institution. If the IFU does not restrict the user, the SFDA has grounds to demand Arabic under the strictest reading. GRZAN advises writing an express limitation, such as a statement that the product is intended for professional healthcare personnel, into the IFU first, then determining the language versions accordingly, since the limitation statement is itself part of the compliance file.

The five label identification items are the minimum set for label design. Annex 1 of MDS-G028 defines identifying information as any statement or information printed, written, or drawn on the device, listing expressly: the device name, the code, lot or batch number or serial number, the technical description, the method of use, and the storage and transport conditions.

These five items stack on top of the UDI requirements rather than replacing them. The UDI consists of the UDI-DI and the UDI-PI and must appear on the label and all higher packaging levels both in easily readable plain text (HRI) and in automatic identification and data capture technology (AIDC). The identifying information answers a different question, whether a human can understand what the device is, how to use it, and how to store it. Neither layer is dispensable, and the data must stay consistent between GHAD and Saudi-DI; see https://www.grzan.cn/regulations/saudi/udi-and-saudi-di-database-37 .

Procedure pack labeling duties descend to the component level. Item 2 of the Notes to Section 3 of MDS-G028 requires a procedure pack to provide the label of each component’s contents in the labeling section. This runs from the same source as the other attached pack requirements: the SFDA treats a pack as an openable collection, not a black box.

For Chinese pack integrators this turns making one label into making one set: the main pack label, each component label, the component list letter, and each component manufacturer’s consent letter, all four synchronized. Any missing item exposes the whole application to rejection; see https://www.grzan.cn/regulations/saudi/mds-g028-bundling-procedure-pack-and-ivd-29 .

Under the reliance pathway the language requirement does not shrink; it becomes more visible. Item 3 of the MDS-G030 general eligibility criteria lists the content and language of labels, instructions for use, and user interfaces among the Saudi-specific applicable requirements, alongside Part 401 of the Saudi Building Code on supply voltage, frequency, and wire insulation colors, and the temperature- and humidity-related storage and transport requirements.

The implication: even with a recognized regulatory authority approval in hand, the label and IFU must still be redone to the Saudi standard; the reliance pathway cannot cover this step. Active devices face the parallel case of the SBC electrical parameters. The impact on budget and timeline should be priced in at project initiation; see https://www.grzan.cn/regulations/saudi/sfda-reliance-pathway-mds-g030-12 .

4. Practical recommendations

• At project initiation produce a user-layering judgment table stating whether each product’s target user is a lay user or a professional, filed in the design history document.
• For lay-user products, prepare Arabic IFU and advertising versions in parallel, reviewed by a linguist with a medical device background.
• Write the user limitation statement into the IFU as the written basis for the language decision.
• Check the label item by item against the 5 identification items: name, code, lot or batch number or serial number, technical description, method of use, storage and transport conditions.
• Apply the UDI in the UDI-DI plus UDI-PI structure, in both HRI and AIDC forms, consistent with the Saudi-DI data.
• Before adopting an e-IFU, verify the conditions of application in the current Annex (10) of MDS-REQ 1 (a practical estimate item); never assume every product can go electronic.
• For procedure pack projects, produce labels component by component and submit them together with the component list letter and the consent letters.
• Later label and IFU updates are changes requiring separate filing; test the change nature before updating; see https://www.grzan.cn/regulations/saudi/significant-and-non-significant-change-46 .
• For active devices on the reliance pathway, check in parallel the voltage, frequency, and wire insulation color requirements of Part 401 of the SBC.

5. Verification checklist

• □ The target user type of each product has been judged and recorded in the design history document
• □ Arabic versions exist for lay-user IFUs and advertising
• □ Professional-user IFUs carry the user limitation statement
• □ The label carries all 5 identification items
• □ The UDI is applied in both HRI and AIDC forms on the label and all higher packaging levels
• □ Model name, GMDN code, and like fields match between GHAD and Saudi-DI
• □ The e-IFU conditions verified against the current Annex (10)
• □ Procedure pack labels provided component by component
• □ Active devices checked against the electrical parameters of SBC Part 401

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Saudi Arabian market. Our team prepares SFDA-compliant STAR dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com