UAE Medical Device Registration for International Manufacturers

Your CE Mark, FDA clearance, or national registration demonstrates product safety and quality, but it does not grant access to the UAE market. This guide explains what international manufacturers need to know about UAE registration, what documentation you can leverage, and how to navigate the process efficiently.

The UAE Market Opportunity

The UAE represents one of the most attractive medical device markets in the Middle East. Valued at approximately USD 1.92 billion in 2023 and growing at nearly 9% annually, the market benefits from world-class healthcare infrastructure, high per-capita healthcare spending, and the nation's strategic ambition to rank among the top 15 healthcare systems globally by 2031.

Critically for international manufacturers, the UAE is an import-dependent market. Approximately 96% of medical devices are imported, primarily from the United States, Germany, Japan, and China. Local manufacturing remains limited to low-technology consumables such as syringes, gloves, and basic disposables. This creates substantial opportunity for foreign manufacturers across virtually all device categories.

Beyond direct market access, the UAE serves as a strategic gateway to the broader Gulf Cooperation Council (GCC) region, Africa, and South Asia. Many international manufacturers establish UAE operations as regional headquarters, leveraging the country's logistics infrastructure, business-friendly environment, and connectivity to emerging markets.

The Common Misconception That Delays Market Entry

International manufacturers frequently approach UAE market entry with a reasonable but incorrect assumption: that existing regulatory approvals from major markets will expedite or simplify the process. The reality requires clarification.

CE Mark does not equal UAE market access. While the UAE's classification system aligns with EU Medical Device Directive principles, CE marking alone does not authorise sale or distribution in the UAE. Separate MoHAP registration is required.

FDA clearance does not equal UAE market access. A 510(k) clearance or PMA approval demonstrates safety and efficacy to US standards, and this documentation supports UAE applications, but it does not substitute for UAE registration.

No mutual recognition agreements exist. The UAE has not entered bilateral recognition agreements with the EU, US, or other major regulatory jurisdictions for medical devices. Each manufacturer must complete the UAE registration process independently.

However, and this is the good news, the UAE regulatory framework is conceptually aligned with international standards. Manufacturers with robust regulatory dossiers from other jurisdictions will find that much of their existing documentation can be leveraged, significantly reducing preparation time and cost.

What Your Existing Approvals Can Do for You

While foreign approvals do not transfer directly, they provide substantial value in the UAE registration process.

ISO 13485 Certification

The UAE accepts ISO 13485:2016 certification directly. If your manufacturing site holds valid ISO 13485 certification from an accredited body, this satisfies MoHAP's quality management system requirements. The certificate must be legalised by the UAE Embassy in your country of origin, but no additional QMS assessment is required. The UAE does not impose additional QMS requirements beyond ISO 13485 compliance.

Technical Documentation

Technical files prepared for EU MDR, FDA submissions, or other major regulatory dossiers contain most of what MoHAP requires. Device descriptions, specifications, risk management files (ISO 14971), biocompatibility data, software documentation, and sterilisation validation: if you have prepared these for another jurisdiction, they can typically be adapted rather than recreated.

Clinical Evidence

Clinical evaluation reports, clinical investigation data, and post-market clinical follow-up information prepared for EU or FDA submissions are generally acceptable to MoHAP. For higher-risk devices (Class III and IV), clinical evidence demonstrating safety and efficacy is required, but manufacturers rarely need to conduct UAE-specific clinical studies if robust data exists from other markets.

Certificates of Free Sale

Free Sale Certificates from your country of origin serve as important supporting documentation, demonstrating that the device is legally marketed elsewhere. These must be authenticated by the UAE Embassy.

Classification Alignment

The UAE follows the Global Harmonization Task Force (GHTF) classification system, which shares conceptual foundations with EU classification rules. Manufacturers familiar with EU MDR classification will find the UAE's four-class system (Class I through IV) conceptually similar, though specific classification determinations should be verified with MoHAP.

Documentation Status by Category

The New Regulatory Landscape: Federal Decree-Law No. 38 of 2024

International manufacturers should be aware that the UAE has recently modernised its regulatory framework. Federal Decree-Law No. 38 of 2024, which came into force on 2 January 2025, replaces the previous Federal Law No. 8 of 2019 governing medical products, pharmacists, and pharmaceutical establishments.

Key Changes Affecting International Manufacturers

• Emirates Drug Establishment (EDE): The EDE is now the central authority overseeing medical product approvals, pharmacovigilance, and market monitoring, consolidating regulatory authority previously distributed across multiple entities.
• Expanded Scope: The law now explicitly covers medical devices alongside pharmaceuticals, cosmetics, and nutritional supplements under a unified framework.
• Fast-Track Provisions: New provisions for compassionate use and expedited approvals have been introduced for innovative treatments and critical medicines, potentially benefiting manufacturers of novel medical devices.
• Enhanced Pharmacovigilance: Stricter requirements for post-market surveillance, adverse event reporting, and product recalls have been mandated.
• Transition Period: A one-year grace period from the effective date allows entities to make necessary changes to comply with the new provisions.

For international manufacturers entering the UAE market now, this regulatory modernisation signals the UAE's commitment to aligning with international best practices while streamlining approval processes. The implementing regulations from the previous law remain in effect where they do not contradict the new legislation.

Jurisdiction-Specific Considerations

While the fundamental UAE registration requirements apply to all international manufacturers, specific considerations vary depending on your country of origin and existing regulatory approvals.

For European Manufacturers

EU-based manufacturers benefit from strong documentation alignment. The UAE's classification system shares conceptual foundations with the EU Medical Device Directive and Regulation. Technical files prepared for CE marking typically require adaptation rather than recreation. Notified Body certificates serve as valuable supporting evidence, and clinical evaluation reports prepared under EU MDR standards are generally accepted by MoHAP. Key considerations include ensuring all certificates are authenticated by the UAE Embassy in your EU member state, and preparing Arabic translations of patient-facing materials.

For US Manufacturers

US manufacturers with FDA clearances hold documentation that substantially supports UAE applications. The 510(k) summary, predicate device comparisons, and clinical data submitted to FDA provide a foundation for UAE technical files. However, manufacturers should note that the UAE's four-class system differs from FDA's three-class approach, and classification mapping requires careful attention. Quality System Regulation (QSR) compliance, while conceptually similar to ISO 13485, may need supplementary documentation to demonstrate full ISO 13485 conformity. FDA establishment registration and device listing do not substitute for UAE site and product registration.

For Russian and EAEU Manufacturers

Russian medical device manufacturers are increasingly viewing the UAE as a strategic market, and for compelling reasons. Bilateral trade between Russia and the UAE has grown substantially in recent years, with over 4,000 Russian companies now registered in the Emirates. Both governments have signalled ambitions to double bilateral trade by 2030, reflecting strong confidence in long-term economic partnership.

The UAE offers Russian manufacturers not only direct market access to a sophisticated healthcare system but also serves as a launchpad for expansion into the broader Middle East, Africa, and South Asia. The country's strategic geographic position, world-class logistics infrastructure, and business-friendly regulatory environment make it an increasingly attractive alternative for companies seeking to diversify their international presence.

Documentation advantages: Russian manufacturers holding GOST ISO 13485-2017 certification possess documentation that aligns directly with UAE requirements. GOST ISO 13485-2017 is the Russian national analogue of ISO 13485:2016, meaning quality management system documentation prepared for Roszdravnadzor or EAEU registration often satisfies MoHAP requirements with appropriate authentication. Technical files prepared for EAEU registration contain much of what MoHAP requires, though adaptation and translation will be necessary.

Key considerations for Russian manufacturers:

• All documents require authentication by the UAE Embassy in Russia
• Russian-language technical files must be translated to English, with Arabic translations required for patient-facing materials
• EAEU registration certificates do not transfer: UAE registration is separate and independent
• A UAE-based Local Authorised Representative must be appointed to handle regulatory affairs
• Classification under Russian national regulations (Class 1, 2a, 2b, 3) maps conceptually to UAE classification (Class I, II, III, IV), but formal classification determination should be obtained from MoHAP

For Russian manufacturers seeking market diversification, the UAE's streamlined regulatory environment, combined with the growing bilateral economic relationship, presents a timely opportunity.

For Asian Manufacturers

Manufacturers from China (NMPA-registered), Japan (PMDA-approved), South Korea (MFDS-cleared), and India have established growing presence in the UAE market. While regulatory systems vary across Asian jurisdictions, the common thread is that existing national registrations do not substitute for UAE approval but do provide valuable supporting documentation. ISO 13485 certification from accredited bodies is accepted regardless of issuing country. Clinical data from well-conducted studies in any jurisdiction is generally acceptable to MoHAP. Manufacturers should ensure that all certificates and supporting documents are authenticated through appropriate UAE diplomatic channels in their respective countries.

The Registration Pathway: An Overview

For international manufacturers new to the UAE market, the registration process follows a structured sequence. Detailed procedural guidance is available in our comprehensive guide, How to Register a Medical Device in the UAE, but the essential pathway is summarised here.

Realistic total timeline: First-time market entry typically requires 6-12 months from initial planning to registration certificate. Subsequent device registrations from the same manufacturer proceed more efficiently, as site registration is already complete and institutional knowledge has been established.

The Strategic Value of UAE Registration

Beyond direct market access, UAE registration offers international manufacturers several strategic advantages.

• GCC gateway: While separate registration is required in each GCC state, UAE approval often facilitates subsequent registrations in Saudi Arabia, Qatar, Kuwait, Oman, and Bahrain through established documentation and regional relationships.
• Health tourism hub: The UAE's position as a leading health tourism destination creates exposure to patients from across the region who subsequently seek the same devices and treatments in their home countries.
• Premium pricing environment: The UAE healthcare system, particularly the private sector, supports premium pricing for innovative devices, often at levels comparable to or exceeding European markets.
• Regional headquarters potential: Many international manufacturers establish UAE operations as regional bases for Middle East and Africa expansion, benefiting from the country's logistics infrastructure, free zone incentives, and connectivity.
• Clinical reference value: Device adoption by prestigious UAE healthcare institutions creates valuable clinical reference sites that support market development across the region.

How Kayrouz & Associates Supports International Manufacturers

Kayrouz & Associates brings nearly two decades of UAE legal experience to medical device companies navigating the regulatory landscape. Since 2006, we have successfully resolved more than 570 matters across diverse practice areas, with particular depth in healthcare regulatory matters.

Our services for international medical device manufacturers include:

• Regulatory Strategy Development: Market opportunity evaluation, pathway assessment, and registration planning tailored to your product portfolio and commercial objectives
• Documentation Guidance: Gap analysis of existing regulatory dossiers, identification of UAE-specific requirements, and guidance on adaptation and authentication
• Local Partner Evaluation: Due diligence on potential Authorised Representatives, relationship structuring, and contractual arrangements
• MoHAP Coordination: Liaison with regulatory authorities, response to information requests, and issue resolution
• Commercial Transactions: Distribution agreements, licensing arrangements, and joint venture structuring
• Ongoing Compliance: Post-marketing obligations, regulatory change monitoring, and registration renewal support

Our team understands both the technical requirements of medical device regulation and the commercial realities of international market entry. We work with manufacturers from all major jurisdictions and maintain current knowledge of regulatory developments in the UAE, EU, US, and other key markets. For manufacturers also considering establishing healthcare facilities in the UAE, we provide integrated support across licensing and operational requirements.

Begin Your UAE Market Entry

The UAE medical device market offers genuine commercial opportunity for international manufacturers prepared to invest in proper regulatory compliance. Whether you are planning initial market entry or seeking to expand an existing portfolio, strategic preparation significantly improves outcomes.

Schedule a consultation with our healthcare regulatory team to discuss your specific situation and receive strategic guidance tailored to your objectives.

For detailed procedural guidance on the UAE registration process, including documentation requirements, fees, and step-by-step instructions, see our comprehensive guide: How to Register a Medical Device in the UAE.

Kayrouz & Associates maintains offices in the UAE and serves clients throughout the Middle East region. This guide provides general information regarding UAE medical device registration for international manufacturers and should not be construed as legal advice applicable to any specific situation.