LIS Consulting Blog – Insights on Medical Device Regulations & Market Trends

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🔍 Browse articles to keep your business compliant and competitive.

The GCC region is entering a new phase of medical device regulation:

🇦🇪UAE: The new Federal Decree-Law No. 38 of 2024 (effective January 2025) expands oversight of medical devices, healthcare products, and supplements.
→ Stronger MAH responsibilities, clear separation of importer/distributor roles, and focus on quality & vigilance.
🇸🇦KSA: Continued rollout of UDI/traceability for better post-market control.
🇦🇪🇸🇦🇰🇼🇶🇦🇧🇭🇴🇲 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.

AI & Medical Device Regulation Update – UAE

The UAE is further accelerating the regulatory framework for AI in healthcare, with new directions given by MoHAP, DHA, and DoH on the following:
• Ethics and transparency in AI use
• More stringent data protection requirements
Validation pathways for AI-based medical devices (SaMD = Software As Medical Device)
• Clearer expectations for compliance by companies seeking to enter the UAE market
At LIS Consulting, 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. 

🇦🇪 Medical Devices in the UAE: Ready to Enter the Market?

Authorities are strengthening regulatory requirements. Your dossier must be clear, complete, and fully compliant.

LIS Consulting supports French-speaking manufacturers:
– MOHAP & DHA registration
– Technical documentation
– Local Authorized Representative & full lifecycle support

Our added value: speed, MedTech expertise, and support in French.

🚀 Looking to register your medical devices or SaMD (Software as a Medical Device) in the UAE?

At LIS Consulting, we support manufacturers and software publishers throughout all stages of registration with UAE health authorities.

💡 Our expertise covers:
✔️ Regulatory classification
✔️ Dossier preparation and submission (MoHAP / DoH / DHA)
✔️ Technical and clinical requirements
✔️ Liaison and follow-up with competent authorities
✔️ Support through to market entry

Our team helps you secure and accelerate your access to one of the most dynamic markets in the Middle East.

🇦🇪 Navigating UAE Medical Device Regulations Made Simple

At LIS Consulting, 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’re 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.

🇦🇪 The UAE Reaffirms Its Commitment to Strengthened Regional Healthcare Cooperation

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.

This participation reflects the UAE’s commitment to improve 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.

🚀 Artificial Intelligence is transforming healthcare but without compliance, there is no trust.

AI is already at the core of the medical sector’s transformation: faster diagnostics, personalized monitoring, improved patient care…However, every innovation must pass a critical step before reaching patients: regulatory approval. At LIS Consulting, we support MedTech companies in registering their AI-based applications and medical devices in the United Arab Emirates (UAE).

💡 MedTech companies in the registration and compliance of their medical software (SaMD) with UAE health authorities.

With our local regulatory expertise, we streamline every step of the process:
✅ Device classification assessment
✅ Registration dossier preparation
✅ Coordination with local health authorities
✅ Ongoing support through to final approval

Our goal: to help you access the UAE market quickly and confidently, while ensuring full compliance with regulatory requirements specific to medical software.

👉 Contact us to learn how we can accelerate the registration of your SaMD (Software as a Medical Device) in the United Arab Emirates.