Healthcare, Medical Device & Pharma Licensing
Healthcare in the GCC is strictly regulated to ensure world-class standards. We navigate medical facility licensing, Emirates Drug Establishment (EDE) marketing authorizations, pharmaceutical import permits, and MOHAP registrations for hospitals, clinics, pharma distributors, and medtech innovators.
Healthcare Authorities & Permitting Pathways
Comprehensive licensing support across federal and emirate health departments.
1. Emirates Drug Establishment (EDE)
Federal authority overseeing registration, classification, and marketing authorization for pharmaceuticals, biologics, and medical devices.
2. Department of Health (DOH Abu Dhabi)
Facility architectural layout approvals, healthcare professional licensing, and clinical inspection readiness for Abu Dhabi.
3. Dubai Health Authority (DHA Sheryan)
Licensing of clinics, day surgery centers, pharmacies, and telehealth platforms operating in the Emirate of Dubai.
4. Ministry of Health and Prevention (MOHAP)
Federal commercial licensing, pharma advertising permits, and medical store Good Distribution Practice (GDP) audits.
Life Sciences & Product Registration Scope
Classification, technical dossier preparation, and import clearance for regulated health products.
Medical Devices (Class I, II, III & IV)
SCOPE 01Product classification, technical file submission, Free Sale Certificate (FSC) verification, and EDE import permits.
Pharmaceuticals & Generic Drugs
SCOPE 02CTD/eCTD dossier submissions, bioequivalence audits, packaging artwork approval, and pricing committee filings.
Health Supplements & Nutraceuticals
SCOPE 03Ingredient safety review, label claims compliance, Certificate of Analysis (COA) review, and MOHAP clearance.
Cosmetics, Disinfectants & Derma
SCOPE 04Montaji registration (Dubai Municipality) and MOHAP medical cosmetic approvals with safety documentation.
Frequently Asked Questions
Key answers on health facility licensing, EDE product registration, and medical distribution.