Ampsy Consultancy LLC provides end-to-end business setup, support, and advisory services in the UAE.
Every medical device and in-vitro diagnostic product must be registered before it can be imported, distributed, or marketed in the UAE. This is now managed by the Emirates Drug Establishment (EDE), which took over device registration from the Ministry of Health and Prevention (MOHAP) as part of a 2025–2026 federal restructuring. Devices are classified by risk — from Class I through Class III — and foreign manufacturers must appoint a UAE-based Local Authorized Representative before applying. Ampsy Consultancy guides you through classification, representation, and dossier submission.
Device Classification: Your product is classified by risk level, in line with globally recognised device classification rules, which determines the documentation and review depth required.
Local Authorized Representative: Foreign manufacturers must appoint a licensed UAE-based representative to submit and manage the application — we help structure this relationship.
Establishment Registration: First-time importers must register their manufacturing site with the regulator before any product application can proceed.
Reliance on Recognised Approvals: The UAE often relies on existing CE marking or FDA clearance, which can streamline the technical file where those approvals already exist.
Post-Market Compliance: Vigilance reporting, adverse event tracking, and renewal management are handled so your device stays compliant after approval.
From appointing your Local Authorized Representative to preparing your classification file and managing the regulatory review, Ampsy Consultancy handles the full process so your medical devices can legally reach the UAE healthcare market.
Ready to register your medical equipment in the UAE? Call Ampsy Consultancy today to get expert consultation!
Ampsy Consultancy LLC
Business setup, legal consulting, and company formation for entrepreneurs establishing their presence in the UAE.
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