The MAH rule
The MAH company registers first, only a licensed warehouse or marketing office can file — classify before you spend.
Free field guide · PDF
UAE MOHAP/EDE Medical Device Registration2026 Field Guide
Marketing authorization with the Emirates Drug Establishment — fees, the 45-working-day timeline, and the MAH rule.
- Working-day service
- 45 days
- Registration fee
- AED 5,000
- Certificate validity
- 5 yrs
Sourced from the EDE official fee schedule and classification practice.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — the EDE official fee schedule and classification practice.
Fees, timeline, validity
AED 5,000 registration fee, a 45-working-day service period, and 5-year certificate validity.
The dossier
Home-market proof, EC/510(k)/PMA conformity evidence, and the product package EDE expects.
Sources & scope
- Emirates Drug Establishment, external user guide — official fee schedule.
- EDE portal, classification of a medical product service.
- Business Setup Dubai, medical equipment company setup 2026.
- Artixio, pharmaceutical facility registration with MOHAP.
This guide is market-access intelligence, not regulatory or legal advice. EDE fee schedules and classification outcomes are product-specific — professional review is required before business use.
Market Access Strategy Session
UAE on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your EDE route — classification, MAH setup, and the authorization filing.
Professional review is required before business use.
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