Clinical Trial & Medical Device Translation in Dubai (2026)
The Short Answer
Companies registering medicines or medical devices in the UAE, and sponsors running clinical studies in Dubai or Abu Dhabi, need two kinds of translation. Patient- and user-facing documents (informed consent forms, patient leaflets, labels and Instructions for Use) need clear, accurate Arabic, normally alongside English. Legal and corporate documents behind a registration (Free Sale Certificates, GMP certificates, distributor agreements and powers of attorney) usually need attestation and certified translation by a translator licensed by the UAE Ministry of Justice (MOJ).
Medicine and medical device registration has moved from the Ministry of Health and Prevention (MOHAP) to the Emirates Drug Establishment (EDE), while clinical research is approved locally, for example by research ethics committees under the Dubai Health Authority (DHA) or the Department of Health – Abu Dhabi (DoH). Smart World Legal Translation (SWLT) is an MOJ-licensed translation office in Abu Dhabi serving Dubai clients online, with medical translators working from 50+ languages.
Which Documents Need Translating
| Category | Examples | Language focus | Certification |
|---|---|---|---|
| Clinical trial patient materials | Informed consent forms (ICFs), patient information sheets, diaries, questionnaires, recruitment material | Plain Modern Standard Arabic a participant can understand, with exact clinical meaning | Ethics committees may ask for a translation certificate or back-translation |
| Protocols and investigator files | Protocols, Investigator’s Brochures, case report forms, adverse event reports | Precise medical and pharmacological terminology consistent with ICH-GCP usage | Certified where filed with an authority or court |
| Medical device documentation | Instructions for Use (IFUs), labels, operator manuals, software interface text | Technical terms that match the device controls and safety warnings | Usually not MOJ-stamped; must match the registered labelling |
| Medicine documentation | Summary of Product Characteristics (SmPC), patient information leaflets, outer packaging text | Standard Arabic names for dosage forms, warnings and adverse reactions | Must match the approved product information |
| Registration certificates and agreements | Free Sale Certificates, GMP and ISO certificates, distributor and authorised representative agreements, POAs | Legal precision on liability, recalls and regulatory duties | Attestation, then MOJ-certified translation |
Requirements differ by product class and authority. Check the current rules with the Emirates Drug Establishment and the relevant ethics committee before you finalise a submission.
Errors That Delay Submissions
Most queries from regulators and ethics committees about translations come down to the same problems:
- The wrong register. An informed consent form written in academic Arabic fails readability review, while an SmPC written in everyday language loses clinical precision. Each document needs its own level.
- Device screens and manual disagree. If the Arabic on the device interface differs from the Arabic in the IFU, nurses and technicians face two names for the same control.
- Abbreviations and units. PRN, BID, IV, SAE and dosage units must be rendered accurately without changing a single value.
- Translating certificates before attestation. A Free Sale Certificate or POA from abroad is attested in the country of origin and by the UAE Ministry of Foreign Affairs first, so the translation includes every stamp. See our MOFA attestation guide.
- Unreviewed machine translation. Automatic tools confuse contraindications with precautions and miss negations, which is a patient-safety risk.
How We Work With Life-Sciences Teams
Medical translators plus a second review
Each file is translated by a linguist experienced in clinical and device documentation, then checked independently for terminology, dosages and figures.
50+ source languages
Dossiers from Germany, France, China, Russia or the US are translated directly into Arabic and English, without chaining through several vendors.
Glossaries across the product
We keep one glossary across the IFU, labels, interface text and training material so the same term appears everywhere.
Confidentiality
We sign NDAs with sponsors, CROs, hospitals and distributors before receiving protocols or proprietary manuals.
Remote service for Dubai
We have no Dubai office; Dubai teams send files on WhatsApp or by email, receive certified PDFs by email, and stamped originals are arranged on request. See our translation services in Dubai.
Frequently Asked Questions
Does an informed consent form need MOJ certification?
Not always. Ethics committees focus on an accurate, readable Arabic version, and some ask for a translation certificate or back-translation. Registration certificates, POAs and agreements filed with an authority usually need MOJ-certified translation.
How much does medical and regulatory translation cost?
From AED 80 per 200-word page for Arabic and English, AED 100 for French, AED 150 for German, Italian or Turkish, and AED 250 for other languages such as Chinese, Russian or Urdu (all excl. 5% VAT). Urgent work is priced on request, and large files receive discounts. Highly technical files are quoted after we see them.
Can you handle a large IFU or an urgent protocol amendment?
Yes. Our team handles up to 100 pages a day. Urgent amendments and safety notices are prioritised and priced on request.
Do you also translate patients’ medical reports?
Yes, see our medical report translation page and the medical sector overview.
Do you offer medical translation training?
Yes, we run a medical translation course for translators and healthcare staff.
Disclaimer
This article is general information about medical and regulatory translation in the UAE and is not medical, legal or regulatory advice. Registration and clinical research requirements are set by the Emirates Drug Establishment, DHA, DoH and other authorities and change over time; confirm them directly before you submit.
Get Your Medical Documents Translated
Send your protocol, IFU or registration documents for a confidential review and a free quote. Smart World Legal Translation is led by Dr. Hani Elimam (MOJ-licensed translator, AIIC member), has translated legal documents since 2014 and is rated 4.8/5 on Google. Send your documents on WhatsApp (+971 50 864 8439), email info@swlt.ae, or use our contact page.