Regulatory Affairs Support for GCC countries & EUROPE product registration
LIS Consulting – Regulatory Affairs Experts in Dubai for UAE, Gulf Cooperation Council (GCC) Countries, and Europe Medical Devices registration
As a trusted partner for regulatory affairs services in the UAE, we deliver end-to-end solutions including:
- Medical device registration in UAE, Gulf Cooperation Council (GCC) Countries, and Europe
- In-vitro diagnostic device approvals
- Personal care product compliance
- Regulatory strategy and market entry planning
LIS Consulting (LIS) is a Dubai-based regulatory affairs consultancy specializing in healthcare compliance and market access across the GCC region & EUROPE. Founded in 2021 and headquartered in the United Arab Emirates, we help medical device manufacturers, in-vitro diagnostic (IVD) companies, and personal care brands achieve regulatory approval and expand into new markets.
LIS Consulting is proudly a member of the Dubai Chamber of Commerce (Membership No. DSO-FZCO-7648), reinforcing our strong ties with the UAE healthcare and business ecosystem.
Our team of seasoned regulatory affairs consultants offers tailored services and flexible engagement models, including remote support and dedicated back-office operations to ensure rapid and efficient project delivery.
LIS Consulting operates as a consortium of expert consultancy firms specializing in regulatory affairs for medical devices and healthcare products. We serve as a reliable regulatory partner to global manufacturers aiming to access markets across the Middle East.
We work closely with regulatory authorities in the GCC region:
- United Arab Emirates (UAE) Ministry of Health and Prevention (MoHAP) (Note: In addition, Dubai Health Authority – DHA and Department of Health Abu Dhabi – DoH regulate at emirate level)
- Saudi Arabia Saudi Food and Drug Authority (SFDA)
- Qatar Ministry of Public Health (MoPH)
- Kuwait Ministry of Health (Kuwait MOH)
- Bahrain National Health Regulatory Authority (NHRA)
- Oman Ministry of Health (Oman MOH)
We work closely with regulatory authorities and Notified Bodies to support European market access:
- Development of EU-compliant Technical Documentation
- Support with CE Marking and Notified Body engagement
- Quality Management System (QMS) audits and MDR/IVDR training
Our proven expertise in local and international regulatory frameworks makes LIS Consulting the go-to firm for fast, compliant, and strategic healthcare market access.
Broad Market Access We have a proven track record of achieving successful market access for medical and IVD devices across regulated and semi-regulated markets. Our compliance-first approach ensures your product meets all applicable standards, including GCC regulations, CE marking, and ISO 13485.
Our team is multilingual (Arabic, English and French) , culturally diverse, and committed to ethical business practices. This ensures strong collaboration with both clients and regulatory authorities, improving communication and outcomes at every step.
Local Agents & Market-Specific Solutions We engage local regulatory agents to handle your product registration with efficiency and cultural alignment. Whether you’re managing multiple distributors or entering a new market, our approach ensures a seamless, centralized process.
Faster Time-to-Market We accelerate your regulatory process by: • Conducting precise mapping of local and international requirements • Consulting directly with authorities (MoHAP, SFDA, JFDA, etc.) • Ensuring full alignment with evolving regulatory guidelines Our expertise reduces delays and optimizes the approval process, saving your team both time and resources.
LIS CONSULTING
Dubai Silicon Oasis, DDP, Building A2, Dubai, United Arab Emirates