Medical Device Registration in the UAE (EDE)
Devices and IVDs registered through the Emirates Drug Establishment — classification confirmed, Local Authorised Representative arranged, technical file built and submitted.
Discuss your device on WhatsAppDevice registration has moved to the EDE
The Emirates Drug Establishment was established under Federal Decree-Law No. 28 of 2023, and Federal Decree-Law No. 38 of 2024 — in force since 2 January 2025 — governs medical products, the pharmacy profession and pharmaceutical establishments — including medical devices and in-vitro diagnostics. Nine core device regulatory services have since transitioned from the Ministry of Health and Prevention to the EDE, covering the full device lifecycle. All new device approvals now go through the EDE portal, and MOHAP no longer accepts these applications.
If you hold an existing MOHAP registration, renewals must now align with EDE requirements, and in some cases documentation has to be resubmitted where portal formatting differs. Maintaining uninterrupted portal access matters for renewals, vigilance reporting and import permits alike.
Classification decides everything that follows
Whether your product is treated as a medical device, an IVD, an accessory or a non-regulated product is now determined exclusively by the EDE. That decision sets your pathway, your documentation, your testing expectations and the clinical evidence threshold you must meet — so it is the first thing to settle, not something to discover mid-review.
Classification is risk-based and aligned with IMDRF principles, judged on intended use, duration of patient contact and degree of invasiveness. If you already hold EU MDR CE marking, your classes generally map across — but the correspondence is not automatic, the EDE reserves the right to reclassify, and software and combination products frequently land differently than manufacturers expect. Where classification is genuinely unclear, a formal classification decision can be requested from the authority before you commit to a submission route.
The Local Authorised Representative
Every foreign manufacturer must appoint a UAE-based Local Authorised Representative, also referred to as the Marketing Authorization Holder. The LAR must be a licensed UAE establishment — typically a medical warehouse or marketing office with a licensed pharmacist in charge — and must complete its own establishment registration with the EDE before any product application can begin. It submits your registration, holds the certificate, applies for import permits and carries regulatory responsibility for complaints, adverse events and recalls.
Worth knowing: the framework under Federal Decree-Law No. 38 moves away from the old single-distributor model. Regulatory representation and commercial distribution no longer have to sit with the same company, which means appointing a distributor no longer has to mean surrendering control of your registration. Before you sign anything, settle who holds the certificate, who applies for import permits, who handles vigilance and recalls, and who owns renewals and amendments.
We arrange the LAR route through UAE-licensed partners while running the regulatory work ourselves — so your registration stays yours.
Existing CE marking or FDA clearance
The EDE review verifies prior approvals, and CE certificates or US FDA clearance carry real weight in the assessment. What they do not do is replace UAE registration. Country-specific requirements still apply in full — a licensed local representative, Arabic labelling and instructions for use, an attested Certificate of Free Sale, and a submission built to EDE portal requirements. We structure the file so your existing approvals do as much work as they legitimately can.
What the technical file needs
- Device classification with documented rationale
- Proof of conformity — CE certificate, FDA clearance or equivalent
- ISO 13485 quality management system certification
- Certificate of Free Sale, attested through the proper chain
- Declaration of Conformity from the manufacturer
- Technical documentation, safety data and performance testing
- Clinical evaluation report
- Manufacturing site licence and site information
- Letter of appointment or agency agreement with the LAR
- Post-market surveillance and vigilance plan
- Labels and instructions for use meeting UAE language requirements
Registration alone does not get your device into the country
A registration certificate permits your device to be placed on the market. Physically importing it requires a separate medical device import permit, applied for by the licensed representative. This is where projects that looked finished stall at the border. We plan the permit alongside the registration rather than treating it as an afterthought.
Post-market obligations
Approval starts a continuing duty. You must operate a vigilance system, report adverse events, and be able to execute a recall. Registrations run for a fixed term and require renewal, and material changes to the device, its manufacturing site or its labelling need fresh approval. We manage the vigilance calendar, renewals and amendments so a certificate does not quietly lapse.
What we handle
- Classification assessment, and formal classification requests where needed
- Local Authorised Representative arrangement through licensed partners
- Establishment registration for the representative
- Gap assessment of an existing CE or FDA technical file against EDE requirements
- Full technical file compilation and EDE portal submission
- Certificate of Free Sale attestation and legalisation coordination
- Arabic labelling and instructions for use
- Import permit applications, including exhibition and trade-show imports
- Vigilance, renewals and post-approval amendments
Coverage
Federal EDE registration for the UAE market, with the emirate health authorities — the Dubai Health Authority and Abu Dhabi's Department of Health — handled where facility-level or local requirements apply. Registering the same device in Saudi Arabia? That runs under SFDA, and we prepare both gateways from one technical file.
How it works
Send your device details, intended use and existing CE or FDA approvals
We confirm classification and the applicable pathway
We arrange the Local Authorised Representative and establishment registration
We compile the technical file, labelling and instructions for use
We submit through the EDE portal, manage queries, then handle the import permit and ongoing vigilance
Not a medical device?
Medicines and biologics
Pharmaceutical marketing authorisation runs a different EDE pathway, with CTD dossiers and a licensed applicant.
Medicine Registration →Supplements and vitamins
Without therapeutic claims these register with Dubai Municipality through Montaji.
Supplement Registration →Frequently asked questions
Does MOHAP still register medical devices?
Do I need a local representative?
My device has CE marking. Is that enough?
How is my device classified?
Can I import once registration is approved?
Must my distributor also hold the registration?
Get your device registered with the EDE
Classification confirmed, representative arranged, technical file built, submission managed through to import.
WhatsApp us about your deviceEmail sales@thecorpbridge.com