Arabic Labeling, UDI & Halal Certification for Medical Devices in MENA (2026)

Why Labeling Compliance Is a Market Access Dealbreaker in MENA

Medical device labeling in the Middle East and North Africa is not a secondary consideration — it is a primary regulatory gatekeeper. Products arriving at ports without compliant Arabic labeling are routinely held at customs. Arabic text that is too small, incorrectly translated, or missing required elements can trigger rejection, delays, and costly relabeling. In some markets, non-compliant labeling can result in products being barred from sale entirely.

The challenge is compounded by the fact that MENA countries do not share a single labeling standard. Each country has its own language requirements, halal certification expectations, and Unique Device Identification (UDI) frameworks. A labeling strategy that works for Saudi Arabia will not automatically satisfy the UAE, Egypt, or Turkey.

This guide provides a comprehensive, country-by-country breakdown of labeling requirements, UDI implementation status, and halal certification frameworks for medical devices across the MENA region.

Country-by-Country Labeling Requirements

Saudi Arabia (SFDA)

Saudi Arabia enforces some of the most detailed labeling requirements in the MENA region, governed by the Saudi Food and Drug Authority (SFDA) under the Medical Devices Interim Regulation.

Language Requirements:

• Home-use devices: Labels and Instructions for Use (IFU) must be in Arabic and English
• Professional-use devices: Labels may be in English only, but Arabic is recommended
• All containers must be marked with gross weight and consignee details
• All products must show the country of manufacture (e.g., "Made in USA")

Required Label Elements:

• Name of the device
• Name and address of the manufacturer
• Special storage conditions
• Warnings and contraindications
• Batch code or lot number
• Date of manufacture and expiry (where applicable)
• Intended use and indications
• Authorized representative details in Saudi Arabia

Key Regulation: SFDA labeling requirements comply with the "Essential Principles of Safety and Performance" specified in Annex (1) and/or Annex (2) of the Medical Devices Interim Regulation, depending on device type.

United Arab Emirates (EDE/MOHAP)

The UAE requires mandatory Arabic labeling on all medical devices, with specific requirements for text prominence.

Language Requirements:

• Arabic is mandatory on all medical device labels
• Arabic text must have equal or greater prominence than English (minimum 1.6mm text height)
• Both Arabic and English must be present for most product categories
• Consumer/non-professional devices: Must include both Arabic and English
• Professional-use devices: English may be primary, but Arabic elements are still required

Date Format: UAE requires Day/Month/Year format (not US-style Month/Day/Year). This is a common source of rejection for US-origin products.

Required Elements (12 mandatory):

1. Product name in Arabic and English
2. Manufacturer name and address
3. Local UAE importer details with trade license number
4. Country of origin
5. Batch/lot number
6. Expiry date (DD/MM/YYYY format)
7. Storage conditions
8. Usage instructions
9. Warnings and contraindications
10. Net quantity
11. Allergen information (where applicable)
12. Product classification

Common Pitfalls:

• Inaccurate Arabic translations (machine translations with errors)
• Missing local importer details
• Incorrect date formats
• Expired certificates accompanying shipments

Egypt (EDA)

Egypt's labeling framework is governed by the Egyptian Drug Authority (EDA).

Language Requirements:

• Labels may be in Arabic or English for medical devices
• For pharmaceutical products and cosmetics, Arabic is mandatory
• Product information must include comprehensive Arabic translations reflecting accurate dosage, usage instructions, contraindications, and warnings

Required Documentation for Labeling Compliance:

• Product information with active ingredients, dosage forms, and intended uses
• Comprehensive Arabic translations of all required information
• Mock-up labels in Arabic compliant with Egyptian graphic standards
• Toxicology and safety data demonstrating product safety and efficacy

Israel (AMAR)

Israel's labeling requirements under the Medical Equipment Law of 2012 are distinct from other MENA countries due to Hebrew language requirements.

Language Requirements by End-User:

• Consumer/home-use devices: Labels and IFUs must be in Hebrew, Arabic, and English (all three languages mandatory)
• Professional-use devices (healthcare facilities only): Labels may be in English only

Required Label Elements:

• Trade name of the product
• Purpose of use and indication
• Name of manufacturer and country of manufacture
• Name and address of the registrant (IRH) including telephone number
• Warnings and restrictions
• "Please consult the leaflet before use" statement
• Production batch number or serial number
• Expiry date (if any)
• Statement if the device contains a pharmaceutical preparation

Additional Requirements: Certain electro-medical devices require validation from the Standards Institution of Israel (SII) under the SI 60601 series for electrical safety and electromagnetic compatibility within the Israeli power grid.

Turkey (TITCK)

Turkey's medical device regulations are closely aligned with the EU MDR/IVDR framework, but with specific Turkish language requirements.

Language Requirements:

• Consumer/home-use devices: Labels and IFUs must be in Turkish
• Professional-use devices: English is generally acceptable, but Turkish translations may be required for certain elements

Regulatory Framework: Turkey implements EU MDR and IVDR-aligned regulations. The Turkish Pharmaceuticals and Medical Devices Agency (TITCK) maintains the National Product Tracking System (ÜTS) for device registration and traceability. TITCK recently published an updated exclusion list clarifying which products do not fall within medical device scope (hospital furniture, general textiles, general laboratory equipment not specifically marketed for medical purposes).

Halal Certification for Medical Devices in MENA

Why Halal Certification Matters for Medical Devices

While halal certification is most commonly associated with food products, it increasingly affects medical devices in MENA markets — particularly devices that contain animal-derived materials (collagen, gelatin, heparin, sutures), devices that contact the body during use, and combination products containing pharmaceutical substances. In Indonesia, halal certification for medical devices is becoming mandatory in phases starting 2026, and the GCC is moving in a similar direction.

GCC-Wide Framework: GSO 2055-1

The GCC Standardization Organization (GSO) established the foundational halal standard GSO 2055-1:2015 ("Halal Food — Part 1: General Requirements"), which defines general requirements for halal products at every stage of the supply chain, including receiving, preparation, packaging, labeling, handling, transportation, distribution, storage, and service.

In February 2026, GSO released a draft update GSO 2055-1:2026 that significantly tightens requirements:

• Transition from voluntary to mandatory halal compliance framework for food, cosmetics, and supplements across GCC markets
• Strengthened supply chain traceability requirements
• Mandatory halal shipment certification for high-risk animal-based products
• Strict segregation, hygiene, and facility transition protocols between halal and non-halal production

The draft was open for public consultation until April 18, 2026. Once finalized, this will raise the compliance bar significantly across all GCC member states.

Saudi Arabia: SFDA Halal Requirements

Saudi Arabia has the most developed halal certification framework in the region:

• Halal logos on products must be SFDA-approved
• Compliance with GSO 2055-1:2015 and GSO 2055-2:2015 for halal management systems and slaughter requirements
• The SFDA Halal Center is expanding mandatory halal certification requirements, including for composite products
• Specific halal labeling guidelines apply to food supplements, with product dossiers, stability testing, and pre-approved health claims

For medical devices containing animal-derived materials, halal certification is increasingly scrutinized during registration review.

United Arab Emirates: MOIAT Framework

The UAE manages halal certification through the Ministry of Industry and Advanced Technology (MOIAT):

• MOIAT is the competent authority overseeing the national halal certification framework
• EIAC (Emirates International Accreditation Center) and ENAS (Emirates National Accreditation System) are the two designated accreditation bodies
• These bodies accredit foreign and domestic halal certification bodies under MOIAT supervision
• Strict rules apply to ingredients, packaging, labeling, storage, and transportation
• Export certifiers must be audited in accordance with UAE.S Halal Guidelines for market entry

The UAE also applies UAE.S 2055-1:2015 (adopted from GSO 2055-1) and UAE.S 2055-4 for halal certification of cosmetics and personal care products, which can encompass certain medical devices.

Qatar: MOPH Requirements

Qatar's halal certification framework operates under the Ministry of Public Health (MOPH):

• Certificates must be issued by Qatar-approved foreign certifiers
• Compliance with GSO 2055-1:2015 for halal compliance
• Requires Arabic halal labeling, proper slaughter methods, and segregation during storage and transport
• Product-specific requirements may apply

Halal Certification Process for Medical Devices

For medical device manufacturers seeking halal certification for MENA markets, the typical process involves:

1. Application: Qualify the product for halal certification through a recognized Halal Certification Body (HCB)
2. Documentation Audit: Submit complete application documents including product composition, ingredient concentration reports, manufacturing process details, and supply chain information
3. On-Site Audit: Factory inspection verifying compliance with halal requirements, including segregation of halal and non-halal materials, cleanliness standards, and ingredient sourcing
4. Certification: Upon successful audit, a Halal Production Facility Registration is issued along with a Halal Product Certificate listing approved products
5. Ongoing Surveillance: Annual audits and compliance monitoring, with certificate validity typically of 3 years

UDI Requirements Across MENA

Saudi Arabia: SAUDI-D Database (Operational)

Saudi Arabia has the most advanced UDI system in the MENA region. The SFDA enacted UDI regulation on August 1, 2021, establishing the SAUDI-D (Saudi Arabia UDI Database).

Key Requirements:

• All devices (Classes A, B, C, D) including IVDs, kits, and accessories must carry UDI
• Accepted issuing agencies: GS1, HIBCC, and ICCBBA
• UDI must contain both Device Identifier (UDI-DI) and Production Identifier (UDI-PI)
• UDI must be presented in human-readable text and barcode (AIDC) format
• Direct marking required for reusable devices
• UDI on base product and all packaging levels
• Approximately 50 data elements must be submitted per device

Submission Requirements:

• Manual entry or XML electronic submission to SAUDI-D
• Non-private data made publicly available
• MD listing number linked to registration
• Arabic language required for brand name and description fields

Import and Distribution Control: For each UDI-DI being imported into KSA, manufacturers, authorized representatives, or importers must provide:

• The applicable Production Identifiers (UDI-PIs)
• Quantity of lot-controlled devices
• Destination (specific distributor, hospital)

UAE: Emerging UDI Framework

The UAE does not yet have a fully operational UDI database comparable to Saudi Arabia's SAUDI-D, but UDI requirements are being integrated into the EDE regulatory framework:

• UDI data elements are increasingly required as part of device registration applications
• The EDE portal collects device identification information during registration
• GS1 standards are widely used in the UAE healthcare supply chain
• Healthcare facilities in Dubai and Abu Dhabi are implementing barcode scanning systems that rely on GS1-compliant UDI data

Manufacturers should prepare UDI data as part of their registration strategy even though formal UDI database submission is not yet mandated at the same level as Saudi Arabia.

Egypt: EDA UDI Requirements

Egypt has established UDI requirements through the President of the Egyptian Drug Authority's Decree No. 499 of 2021:

• Medical device factories, companies, distributors, importers, and warehouses are required to use the Global Trade Item Number (GTIN) barcode for all medical supplies traded in the local market
• This is implemented through the "Me Device" electronic platform
• If a medical device is encoded with another IMDRF-designated issuing agency, the brand owner or agent must submit a request to EDA reporting the issuing agency used

Egypt's UDI requirements focus primarily on supply chain tracking and anti-counterfeiting rather than the comprehensive database approach seen in Saudi Arabia.

Turkey: EU-Aligned UDI Framework

Turkey's TITCK aligns its UDI requirements with the EU MDR framework:

• UDI requirements follow EU MDR Article 27 and related implementing acts
• The National Product Tracking System (ÜTS) serves as Turkey's device registration database
• EUDAMED UDI requirements (becoming mandatory May 28, 2026 for EU) influence Turkish requirements
• GS1 Turkey is the primary issuing agency

Regional UDI Compliance Timeline

Practical Compliance Strategy

Building a Unified Labeling Approach

For manufacturers operating across multiple MENA markets, a tiered labeling strategy is most efficient:

Tier 1 — Universal Base Label (English): All required elements per IMDRF Essential Principles — device name, manufacturer, lot number, expiry, storage conditions, warnings.

Tier 2 — Market-Specific Overlays:

• Saudi Arabia: Add Arabic translations, SFDA-approved halal logos (if applicable), UDI in SAUDI-D format
• UAE: Add Arabic text with equal prominence (≥1.6mm height), UAE importer details, DD/MM/YYYY dates
• Egypt: Add Arabic or confirm English compliance, GTIN barcode
• Israel: Add Hebrew, Arabic, and English (for consumer devices); English only for professional
• Turkey: Add Turkish (for consumer devices), ÜTS registration data

Tier 3 — IFU Localization: Translate Instructions for Use into the required local language(s), ensuring technical accuracy and cultural appropriateness. Avoid machine translation for regulatory submissions — authorities compare Arabic text against English for accuracy.

UDI Data Management

With Saudi Arabia's SAUDI-D operational and Egypt's GTIN mandate in effect, manufacturers should:

1. Assign UDI-DIs using GS1 (most widely accepted across MENA), HIBCC, or ICCBBA standards
2. Maintain a centralized UDI database that can export data in formats required by SAUDI-D (XML), EUDAMED, and other regional databases
3. Establish processes for UDI lifecycle management — new UDI-DI required for device changes (new versions, models, packaging configurations)
4. Link UDI-DIs to previous versions in the SAUDI-D database when updating device registrations
5. Prepare Arabic brand name and description data for Saudi submission requirements

Halal Certification Preparation

For devices containing animal-derived materials or positioning for broad MENA market access:

1. Audit your supply chain for animal-derived ingredients (collagen, gelatin, heparin, bovine/porcine tissue products)
2. Engage a recognized Halal Certification Body such as SGS (accredited by EIAC/ENAS for UAE), American Halal Foundation (recognized by multiple MENA authorities), or other GSO-compliant certifiers
3. Prepare documentation including complete ingredient lists, supplier certificates, manufacturing process flow diagrams
4. Plan for the GSO 2055-1:2026 update — once finalized, compliance requirements will be stricter across all GCC markets

Key Takeaways

1. Arabic is non-negotiable in Saudi Arabia and UAE — ensure professional translations (not machine-generated) that meet minimum text height requirements and pass authority review.

2. Israel requires three languages (Hebrew, Arabic, English) for consumer/home-use devices, while allowing English-only for professional devices — a unique requirement in the region.

3. Saudi Arabia's SAUDI-D is the most mature UDI database in MENA with approximately 50 data elements per device including mandatory Arabic brand name and description. Compliance has been enforceable since 2023.

4. GSO 2055-1:2026 will tighten halal requirements across all GCC markets from voluntary to mandatory compliance — manufacturers with animal-derived materials in their devices should begin certification now.

5. Egypt's GTIN mandate (Decree 499/2021) requires all medical device companies to use GS1 barcodes through the "Me Device" platform — a baseline UDI requirement that affects all market participants.

6. Turkey follows EU timelines for UDI — with EUDAMED becoming mandatory in May 2026, Turkish UDI requirements will accelerate in parallel.