Labeling, IFU, Packaging & Market-Claim Compliance (UAE)

The Product Presented in the UAE Must Match the Registered Regulatory Position. Labels, IFUs, packaging and product brochures are part of the evidence submitted to MOHAP and should remain consistent with the registered intended purpose, model list, warnings, precautions and supporting evidence. English or Arabic product information may also be relevant depending on the application and product presentation.

Review Your UAE Labeling

When This Support Is Needed

Preparing Arabic and English product labels, packaging artwork, and IFUs for UAE market launch

Verifying commercial brochures, leaflets, and promotional materials against registered MOHAP claims

Implementing Unique Device Identification (UDI) barcodes on device primary and secondary packaging

Updating manufacturer, licensed local marketing office, or storage condition statements on labeling

What We Challenge Before Submission

Does the product require mandatory Arabic instructions for use based on its intended user (lay user vs healthcare professional)?

Are the licensed UAE applicant's legal details and MOHAP registration reference numbers formatted correctly?

Do UDI identifiers and model reference numbers match the registered commercial catalogue exactly?

Do promotional marketing claims in brochures strictly reflect the clinical intended purpose authorized by MOHAP?

Are temperature, humidity, sterility, and expiration symbols completely aligned with stability validation reports?

Our Labeling & Packaging Review Scope

Product label and Instructions for Use (IFU) regulatory compliance review against MOHAP guidelines

Bilingual Arabic and English language presentation review for professional and home-use medical devices

Legal manufacturer and UAE licensed medical warehouse / MAH identification on packaging

Warnings, contraindications, precautions, and residual risk statement harmonization

Standardized symbol verification (ISO 15223-1) and localized storage/sterility condition labeling

UDI barcode verification (GS1 / HIBCC) and product identifier consistency review

IVD-specific labeling, reagent storage temperatures, specimen handling, and performance claims

Electronic Instructions for Use (e-IFU) eligibility assessment and compliance

Packaging artwork, clinical user manual, and commercial marketing brochure review

Regulatory impact assessment for post-approval packaging revisions and artwork updates

Consistency Rule:

We compare the market-facing product against the registration dossier. A seemingly simple label change can become a regulatory issue if it changes intended purpose, indications, performance claims, user population or risk controls.

Harmonize Your Bilingual Packaging and Promotional Claims for the UAE

Our labeling consultants audit artwork for MOHAP compliance, translate clinical IFUs into Arabic, and verify UDI identifiers.

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