The United Arab Emirates (UAE) is a highly attractive and rapidly expanding market for pharmaceutical and medical device manufacturers, supported by a strong economy, clear regulatory guidelines, and increasing healthcare investments.
The Ministry of Health and Prevention (MoHAP) is the primary federal authority regulating the importation, registration, and marketing of medicinal products and medical devices in the UAE, with additional oversight from emirate-level bodies such as the Dubai Health Authority (DHA) and Abu Dhabi Department of Health (DoH) for certain activities. While the UAE offers streamlined processes for many approvals, navigating multi-level requirements, documentation standards, and potential procedural delays can be complex for foreign manufacturers. MedWisdom LifeScience provides expert, end-to-end regulatory affairs support as a trusted global partner. We help overcome these challenges by delivering comprehensive services to minimize compliance risks, accelerate approvals, and ensure efficient, successful market entry and sustained operations in the UAE.
Get UAE Compliance Support
Full support for MoHAP product registration, marketing authorization applications, establishment licensing, and renewals for pharmaceuticals and medical devices.
Expert preparation, review, compilation, and maintenance of regulatory dossiers in CTD/eCTD format compliant with MoHAP and Gulf standards.
Local pharmacovigilance system setup, adverse event reporting to MoHAP, PSUR/PBRER submissions, signal detection, and risk management in the UAE.
Conducting gap analyses, internal audits, and preparation for MoHAP inspections to ensure ongoing compliance with UAE regulatory requirements.
Support for obtaining import/export permits, customs clearance documentation, batch release certificates, and MoHAP import authorization processes.
Development of risk management plans, benefit-risk evaluations, mitigation strategies, and proactive compliance measures tailored to UAE regulations.
Partner with Medwisdom for expert, efficient, and fully compliant regulatory support in the United Arab Emirates — from MoHAP registrations and dossier management to pharmacovigilance, import licensing, and long-term market success.
Contact Our UAE Regulatory Experts