We primarily work with medical device manufacturers, SaMD, AI-driven or AI-powered MD, in-vitro diagnostic (IVD) companies, personal care brands, importers, and distributors who need to register or maintain products in the UAE and wider GCC markets. Our team is multilingual (Arabic, English, and French) allowing us to serve both international and regional clients effectively.

We operate across all six GCC countries: the UAE (MoHAP, DHA, DoH), Saudi Arabia (SFDA), Qatar (MoPH), Kuwait (Kuwait MOH), Bahrain (NHRA), and Oman (Oman MOH). Our team engages directly with all relevant regulatory authorities in each market.

Our regulatory strategy service provides end-to-end advisory tailored to your product and target market. This includes global and regional regulatory pathway mapping, technical file preparation, submission management, and direct liaison with regulatory authorities. We help you minimise time-to-market while remaining fully compliant with UAE and GCC requirements.

Our dossier review service covers a thorough assessment of all technical, clinical, and administrative sections of your submission file. We identify gaps against applicable regulations including GHTF, EU MDR, and GCC-specific guidelines and professionally reformat documentation to meet the standards required by authorities.

Yes. We manage the entire submission process from end to end. This includes electronic or manual submission to health authorities, tracking and following up on submission progress, responding to authority queries and deficiency letters, and coordinating all steps through to final approval or licensing.

Yes. UAE health authorities require international manufacturers to appoint a locally registered entity as their authorized representative. LIS Consulting can serve as your Local Authorized Representative, handling regulatory obligations on your behalf — including vigilance, post-market reporting, and authority correspondence — so you can operate in the market without needing a local entity of your own.

The easiest way to begin is to schedule a meeting via our website or reach out through our contact page. Our team will assess your product, target market, and regulatory needs, then propose a tailored engagement including flexible remote support and dedicated back-office operations where needed.