LIS Consulting – Regulatory Affairs Experts in Dubai for UAE, GCC Countries and European Medical Device (CE Mark) Compliance

LIS Consulting (LIS) is a Dubai-based regulatory affairs consultancy specializing in healthcare compliance and market access across the GCC region. 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.

Regulatory Affairs Support for GCC countries product registration

As a trusted partner for regulatory affairs services in the UAE, we deliver end-to-end solutions including:

• Medical device registration in UAE and Gulf Cooperation Council (GCC) Countries.
• In-vitro diagnostic device approvals
• Personal care product compliance
• Regulatory strategy and market entry planning

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)

Our proven expertise in local and international regulatory frameworks makes LIS Consulting the go-to firm for fast, compliant, and strategic healthcare market access.

European Market Regulatory Services

In addition to GCC regulatory support, LIS Consulting provides specialized regulatory affairs services for the European market, helping manufacturers achieve and maintain compliance with EU MDR / IVDR requirements.

Our European services include:

• CE marking regulatory strategy and pathway definition
• EU MDR / IVDR technical documentation review and gap assessment
• Quality Management System (QMS) setup and remediation (ISO 13485 / EU MDR alignment)
• Support for Notified Body audit preparation and responses
• Clinical evaluation and PMS/PMCF documentation support
• EU Authorized Representative coordination and compliance support
• Regulatory strategy for EU market entry and product lifecycle management

We support manufacturers in identifying compliance gaps, strengthening technical documentation, and ensuring readiness for regulatory audits and CE certification.

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 and European regulations and ISO 13485.

Expert Team 🗣️

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 Agent 🌍

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. 

Regulatory Affairs ✅

Faster Time-to-Market: We accelerate your regulatory process by: • Conducting precise mapping of local and international requirements (Europe & GCC) • Consulting directly with notified bodies & authorities (G-Med, BSI, ANSM, 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.