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.
🌍 Coverage Across Middle Eastern Markets
MOHAP, DHA, HAAD
MOPH
MOH
Egypt CAPA & Regional Authorities
Specialized Middle East Regulatory Expertise
At RABT Global, we offer specialized Regulatory Services for Medical Devices across key Middle Eastern markets with deep expertise in regional regulatory affairs.
🇶🇦 Qatar
🇴🇲 Oman
🇰🇼 Kuwait
🇧🇭 Bahrain
🇯🇴 Jordan
🇪🇬 Egypt
⚠️ Key Requirement: Each country in the Middle East follows unique regulatory frameworks that require in-depth local knowledge, experience, and strong connections with local health authorities.
Why RABT Global?
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.
Medical Device Regulatory Services Across the Middle East
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.
Regulatory Strategy & Compliance Planning
Risk classification and product registration pathway. Documentation readiness assessment.
Strategy
Medical Device Registration & Dossier Preparation
Direct coordination with regulatory bodies including UAE MOHAP, Qatar MOPH, Kuwait MOH, Egypt CAPA, and others. End-to-end tracking until registration approval.
Registration
Local Authorized Representative (LAR) Services
Managing legal and regulatory responsibilities on your behalf.
LAR Services
Labeling Compliance & Arabic Translation
Certified Arabic translations. Packaging compliance and technical file updates.
Labeling
Import License & Distribution Support
Support in registration renewals, license variations, and distributor coordination.
Import & Distribution
Vigilance, PMS & Regulatory Maintenance
Incident reporting and adverse event handling. Product recalls, field safety corrective actions (FSCA), and continuous regulatory monitoring.
Post-Market
Regulatory Submissions & Post-Approval Services
RABT Global supports regulatory submissions and post-approval services across key Middle Eastern markets.
Gulf Cooperation Council (GCC) Markets
UAE, Qatar, Kuwait, Oman, and Bahrain
United Arab Emirates — MOHAP, DHA, HAAD
Qatar — Ministry of Public Health (MOPH)
Kuwait — Ministry of Health (MOH)
Oman — Regulatory submissions and post-approval services
Bahrain — Regulatory submissions and post-approval services
Levant & North Africa Markets
Jordan and Egypt
Jordan — Regulatory submissions and post-approval services
Egypt — CAPA (Central Administration of Pharmaceutical Affairs)
Direct coordination with local health authorities across all markets
End-to-end tracking until registration approval in each country
Certified Arabic translations for labeling and packaging compliance