Seamless Regulatory Support for Medical Devices Across the Middle East
The Middle East is a dynamic and expanding market for medical devices, fueled by rising healthcare demand, advanced infrastructure, and supportive government initiatives. However, each country in the region follows unique regulatory frameworks that require in-depth local knowledge and experience.
At RABT Global, we offer specialized Regulatory Services for Medical Devices across key Middle Eastern markets. With deep expertise in regional regulatory affairs and strong connections with local health authorities, we help medical device manufacturers accelerate market entry while maintaining full compliance.
Our Comprehensive Regulatory Services
1. Regulatory Strategy & Compliance Planning
In-depth regulatory intelligence across GCC and non-GCC countries
Risk classification and product registration pathway
Documentation readiness assessment
2. Medical Device Registration & Dossier Preparation
Preparation and submission of regulatory dossiers in required formats (CSDT, GHTF, SFDA e-services, etc.)
Direct coordination with regulatory bodies:
Saudi Food and Drug Authority (SFDA)
UAE Ministry of Health and Prevention (MOHAP)
Qatar MOPH, Kuwait MOH, Egypt CAPA, and others
End-to-end tracking until registration approval
3. Local Authorized Representative (LAR) Services
Acting as or coordinating with in-country representatives
Managing legal and regulatory responsibilities on your behalf
4. Labeling Compliance & Arabic Translation
Review of IFU, labels, and artwork in accordance with local requirements
Certified Arabic translations
Packaging compliance and technical file updates
5. Import License & Distribution Support
Import license acquisition and customs clearance documentation
Support in registration renewals, license variations, and distributor coordination
6. Vigilance, PMS & Regulatory Maintenance
Post-market surveillance setup and compliance
Incident reporting and adverse event handling
Product recalls, field safety corrective actions (FSCA), and continuous regulatory monitoring
Coverage Across Middle Eastern Markets
RABT Global supports regulatory submissions and post-approval services in:
Saudi Arabia (SFDA)
United Arab Emirates (MOHAP, DHA, HAAD)
Qatar (MOPH)
Oman
Kuwait
Bahrain
Jordan
Egypt
Why RABT Global?
Regional Expertise with strong local presence and regulatory know-how
End-to-End Support from strategy to lifecycle maintenance
Accelerated Market Entry through well-established processes and authority relationships
Quality & Compliance Focus aligned with global and regional standards
