\ud83d\udd0d Browse articles to keep your business compliant and competitive.<\/strong><\/p>\n\n\n The GCC region is entering a new phase of medical device regulation: AI & Medical Device Regulation Update – UAE<\/strong> <\/p>\n\n\n\n \ud83c\udde6\ud83c\uddea Medical Devices in the UAE: Ready to Enter the Market? \u2728 LIS Consulting supports French-speaking manufacturers: \ud83d\udca1 Our added value: speed, MedTech expertise, and support in French.<\/p>\n\n\n\n <\/p>\n\n\n\n \ud83d\ude80 Looking to register your medical devices or SaMD in the United Arab Emirates? \ud83d\udca1 Our expertise covers: Our team helps you secure and accelerate your access to one of the most dynamic markets in the Middle East.<\/p>\n\n\n\n \ud83c\udde6\ud83c\uddea Navigating UAE Medical Device Regulations Made Simple <\/p>\n\n\n\n \ud83c\udde6\ud83c\uddea The United Arab Emirates Reaffirms Its Commitment to Strengthened Regional Healthcare Cooperation This participation reflects the UAE\u2019s commitment to \u062a\u0639\u0632\u064a\u0632 regional healthcare collaboration across the Gulf by promoting joint initiatives and implementing integrated projects aimed at improving the efficiency, sustainability, and resilience of healthcare systems within GCC countries.<\/p>\n\n\n\n \ud83d\ude80 Artificial Intelligence is transforming healthcare \u2014 but without compliance, there is no trust. However, every innovation must pass a critical step before reaching patients: regulatory approval.<\/p>\n\n\n\n At LIS Consulting, we support MedTech companies in registering their AI-based applications and medical devices in the United Arab Emirates (UAE).<\/p>\n\n\n\n Our mission: to simplify your regulatory pathway, secure your innovations, and accelerate your time to market.<\/p>\n\n\n\n \ud83d\udca1 Healthcare innovation deserves to be deployed with confidence \u2014 through rigor, transparency, and local expertise. \ud83d\udcbb Are you developing a SaMD (Software as a Medical Device) and planning to commercialize it in the United Arab Emirates? \ud83c\udde6\ud83c\uddea With our local regulatory expertise, we streamline every step of the process: Our goal: to help you access the UAE market quickly and confidently, while ensuring full compliance with regulatory requirements specific to medical software.<\/p>\n\n\n\n \ud83d\udc49 Contact us to learn how we can accelerate the registration of your SaMD in the United Arab Emirates.<\/p>\n\n\n\n <\/p>\n\n\n\n \ud83e\ude7a The Dubai Health Authority (DHA) has issued new Guidelines on Health Technology Assessment (HTA) for medical equipment and emerging therapeutic practices. <\/p>\n\n\n\n![\"\"](\"https:\/\/lisconsultgroup.com\/wp-content\/uploads\/2025\/12\/image-5.jpeg\")
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\ud83c\udde6\ud83c\uddeaUAE: The new Federal Decree-Law No. 38 of 2024 (effective January 2025) expands oversight of medical devices, healthcare products, and supplements.
\u2192 Stronger MAH responsibilities, clear separation of importer\/distributor roles, and focus on quality & vigilance.
\ud83c\uddf8\ud83c\udde6KSA: Continued rollout of UDI\/traceability for better post-market control.
\ud83c\udde6\ud83c\uddea\ud83c\uddf8\ud83c\udde6\ud83c\uddf0\ud83c\uddfc\ud83c\uddf6\ud83c\udde6\ud83c\udde7\ud83c\udded\ud83c\uddf4\ud83c\uddf2 Regional trend: Growing alignment with EU MDR principles and IMDRF guidance to harmonize standards across GCC. Companies operating in the GCC should reassess MAH agreements, supply-chain roles, and documentation to stay compliant.<\/p>\n\n\n\n
The UAE is further accelerating the regulatory framework for AI in healthcare, with new directions given by MoHAP, DHA, and DoH on the following:
\u2022 Ethics and transparency in AI use
\u2022 More stringent data protection requirements
Validation pathways for AI-based medical devices (SaMD)
\u2022 Clearer expectations for compliance by companies seeking to enter the UAE market
At LIS Consulting<\/strong>, we guide MedTech and HealthTech organizations on navigating these changing regulations.
Looking Ahead : WHX 2026 (February)
The coming WHX 2026-MedTech edition will be a significant platform for companies to understand AI-driven innovation and upcoming regulatory changes in the UAE. <\/p>\n\n\n\n
Authorities are strengthening regulatory requirements. Your dossier must be clear, complete, and fully compliant.<\/p>\n\n\n\n
\u2013 MOHAP & DHA registration
\u2013 Technical documentation
\u2013 Local Authorized Representative & full lifecycle support<\/p>\n\n\n\n
At LIS Consulting, we support manufacturers and software publishers throughout all stages of registration with UAE health authorities.<\/p>\n\n\n\n
\u2714\ufe0f Regulatory classification
\u2714\ufe0f Dossier preparation and submission (MoHAP \/ DoH \/ DHA)
\u2714\ufe0f Technical and clinical requirements
\u2714\ufe0f Liaison and follow-up with competent authorities
\u2714\ufe0f Support through to market entry<\/p>\n\n\n\n
At LIS Consulting<\/strong>, we support manufacturers, distributors, and innovators with:
– End-to-end medical device registration (MOHAP, DoH, DHA)
– Regulatory strategy & gap assessments
– Quality management system (QMS) setup aligned with UAE requirements
– Technical file review for smooth and fast approvals
– Ongoing regulatory maintenance and post-market support
Whether you\u2019re entering the UAE for the first time or updating your existing registrations, the right guidance ensures faster approvals, fewer delays, and full compliance with local frameworks.<\/p>\n\n\n\n
The Minister of Health and Prevention led the UAE delegation at the 11th GCC Health Ministers Meeting and the 88th GCC Health Ministers Council meeting, held in Kuwait.<\/p>\n\n\n\n
AI is already at the core of the medical sector\u2019s transformation: faster diagnostics, personalized monitoring, improved patient care\u2026<\/p>\n\n\n\n
Ready to launch your AI solution in the UAE market?<\/p>\n\n\n\n
We support MedTech companies in the registration and compliance of their medical software (SaMD) with UAE health authorities.<\/p>\n\n\n\n
\u2705 Device classification assessment
\u2705 Registration dossier preparation
\u2705 Coordination with local health authorities
\u2705 Ongoing support through to final approval<\/p>\n\n\n\n
This initiative ensures that innovative technologies entering Dubai\u2019s healthcare system are safe, effective, and deliver proven clinical and economic value
For manufacturers and healthcare innovators, this means more structured evaluation requirements and a clearer framework for market access in Dubai.
In this evolving regulatory landscape, having a reliable local partner who understands UAE and regulatory GCC compliance is essential to navigate submissions, approvals, and post-market expectations effectively.<\/p>\n\n\n\n