Medical device labelling in the UAE and Saudi Arabia should be reviewed as part of regulatory preparation, not left until packaging is ready for production. The UAE’s Emirates Drug Establishment (EDE) requests packaging and product information within its medical-device registration documentation, while the Saudi Food and Drug Authority (SFDA) specifies requirements for labels, instructions for use and information supplied by manufacturers. (Source: SFDA)
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For manufacturers planning entry into both markets, a practical starting point is to establish one controlled set of product information, then assess the changes needed for each country. Do not assume that artwork prepared for one market is automatically suitable for another.
Medical device labelling in the UAE
EDE’s medical-device marketing authorisation service requests product descriptions, models, sizes, accessories, uses, warnings, precautions, usage guidelines, packaging photographs, brochures and usage manuals. Manufacturers should therefore review packaging, instructions and technical documentation together, checking that the same product identity and intended use appear throughout. (Source: EDE)
EDE’s separate product-classification service lists “leaflet/product information in English/Arabic” and requests clear, readable inner and outer packaging artwork. This wording should not be treated as a complete language rule for every medical-device category; confirm the applicable language expectations for the specific product and submission pathway before approving final artwork. (Source: EDE)
A useful preparation approach is to create a UAE labelling checklist covering the product’s regulatory category, intended user, packaging levels and accompanying information. Record any authority clarification alongside the artwork approval so the basis for each decision remains traceable.
Medical device labelling in Saudi Arabia
Saudi requirements distinguish between professionally qualified users and lay users: SFDA’s implementing regulation accepts labelling information in English for professionally qualified users, while labels for devices intended for lay users must be in Arabic and English. The same regulation requires manufacturers of home-use medical devices to provide bilingual labelling, including display screens. (Source: SFDA)
SFDA’s marketing authorisation requirements also specify Arabic and English manufacturer information for devices used by lay persons and for in vitro diagnostic devices intended for self-testing. Identify the intended user early, then use that determination to guide the review of labels, instructions and relevant user-interface content. (Source: SFDA)
Translation should be managed as a controlled technical activity. Ask the manufacturer to approve translated content against the original intended use, safety information and operating instructions before releasing it for production.
What should a labelling review cover?
Use the following as a working review checklist, not as a substitute for the applicable authority requirements. Assess each item against the device’s characteristics and intended use.
- Product identity: Check the product name, model, catalogue reference and packaging description against the registration documentation.
- Manufacturer information: Verify the legal manufacturer’s name and address, and assess any applicable local-entity information.
- Traceability: Review lot numbers, serial numbers and applicable device-identification requirements.
- Dates and storage: Check relevant manufacturing dates, expiry information, storage conditions and handling instructions.
- Safety information: Review warnings, precautions, sterile status, single-use information and other device-specific statements.
- Instructions for use: Confirm that instructions correspond to the supplied device, accessories, intended users and operating environment.
- Language and readability: Check translation accuracy, legibility, symbols and consistency across packaging and accompanying materials.
SFDA’s requirements expressly address manufacturer identification, lot or serial numbers, relevant safe-use dates, storage conditions, sterile status, warnings and precautions. Use those provisions to build the Saudi checklist, while separately confirming the UAE requirements for the product concerned. (Source: SFDA)
Keep artwork under change control
Before approving a new label or instruction manual, compare it with the version used in the regulatory submission. Check whether changes to product claims, manufacturer details, warnings or instructions require a regulatory assessment before implementation.
Maintain a version-controlled record of approved artwork, translations and supporting decisions. This provides a clear reference for manufacturers, local partners and regulatory teams when preparing submissions or reviewing later changes.
How HERMS can support
HERMS provides consultancy and advisory support to pharmaceutical and healthcare companies across regulatory affairs and market access. We help businesses prepare regulatory documentation and assess their market-entry priorities.
Planning a medical-device submission in the UAE or Saudi Arabia? Contact HERMS to discuss your documentation and regulatory support needs. Contact HERMS