Medical Device Registration Renewal in the UAE (2026)
Ultimate Guide — When, How & What You Must Prepare
Renewing a medical device registration in the United Arab Emirates (UAE) isn’t just a formality — it’s a rigorous regulatory step that determines whether your products can continue to be imported, marketed, sold, and supplied in the UAE market. The process and compliance requirements are mandated by the Ministry of Health and Prevention (MOHAP) and/or the Emirates Drug Establishment (EDE) — depending on where your registration was originally issued.
Why Renewal Is Critical
Medical device registrations in the UAE are not perpetual. They have finite validity and must be renewed to:
Maintain legal market access
Enable customs clearance of shipments
Avoid regulatory penalties
Ensure continued distribution or tender participation in hospitals and health facilities
Under UAE regulations, a registered medical device marketing authorization remains valid for a fixed period after issuance and must be professionally renewed before expiry.
📆 Validity & Timeline — When to Renew
Standard Validity Period
Medical device registrations in the UAE are valid for 5 years from the date of the last expiry/approval.
Recommended Renewal Window
Begin the renewal process 3–6 months before expiration to avoid processing delays.
Renewal applications are typically processed within ~15 working days once all documents are submitted, and fees are paid.
⚠️ If you delay beyond expiry, your registration may lapse. This can lead to:
Suspension of import permits
Blocked customs clearance
Loss of distribution rights
Regulatory fines
Who Must Apply
To file a renewal application for a medical device in the UAE:
✔️ Your company must already be a registered Marketing Authorization Holder (MAH) with MOHAP or EDE.
✔️ The applicant must be a medical warehouse or a marketing office with a valid UAE license.
This means only legally registered entities with valid operating licenses can maintain or renew device registrations.
Step-by-Step Renewal Process
1. Create/Login to Your Regulatory Account
Log in via the MOHAP or EDE e-portal using UAE PASS.
2. Start a Renewal Application
From your dashboard, choose “Renewal of Registration of Medical Devices/Equipment”
3. Complete the Online Application Form
Ensure that all product identifiers, model numbers, and classifications are accurate.
Cross-check details against your existing registration.
4. Upload Required Supporting Documents
This is the most critical phase — missing or incorrect documents are the leading cause of delays.
5. Pay Fees
Pay the mandatory application and renewal fees via e-payment.
6. Wait for Committee Review
Your file is reviewed by the technical and ministerial committees. Decisions are communicated formally through the portal and email.
7. Download Renewed Certificate
Once approved, a new marketing authorization certificate is issued, valid for the next 5 years.
Read More: Challenges in UAE Medical Device Registration(and Solutions)
Documents Checklist — What You Must Prepare
✔️ Original registration certificate (previously issued)
✔️ Application form for renewal completed & signed
✔️ Valid manufacturing certificate issued previously by MOHAP/EDE
✔️ Certificate of Free Sale or Registration from the country of origin
✔️ Minor variation certificates, if changes were previously submitted
✔️ Quality conformity certificates/ regulatory approvals such as:
CE Declaration of Conformity
US FDA 510(k)/PMA
Other internationally recognized conformity documents
✔️ Post-marketing surveillance / monitoring reports (as applicable)
✔️ Samples (when required) — usually 3 physical samples, with:
Certificate of Analysis
Product brochures and packaging graphics
✔️ Company affirmation of compliance with regulatory technical specifications (e.g., conformity with Medical Equipment Manual/EC DoC).
💰 Renewal Fees — What to Budget For
Fee Type | Amount (AED) |
Application Fee | 100 AED |
Renewal of Medical Device Registration | 2,500 AED |
💡 Note: Fees may vary slightly based on device class or specific authority (MOHAP vs EDE), but the above amounts reflect the current official fee structure.
Device Classification & Renewal Complexity
The UAE generally classifies medical devices into risk classes (I, II, III, IV) based on their intended use and risk profiles. Higher-risk devices often require more stringent documentation (e.g., clinical evidence, performance data).
Therefore:
✔️ Class I devices have a relatively straightforward renewal.
✔️ Class III/IV devices may require additional compliance evidence, data reports, or audit documentation.
Common Renewal Pitfalls & How to Avoid Them
❌ 1. Missing or Incomplete Documentation
Solution: Prepare all certificates, analysis reports, and conformity evidence in advance.
❌ 2. Not Addressing Minor Variations
If changes were previously made to the device (labelling, manufacturing site, or technical specs), ensure all variation certificates are included.
❌ 3. Late Submissions
Starting within 3–6 months before expiry is best practice.
❌ 4. Incorrect Entity Registration
Ensure your MAH entity has an active license that is valid throughout the renewal period.
🗂️ Special Case: Renewal of Manufacturer Registration
If your company is a manufacturing site, its site registration also needs renewal — separate from individual product renewals. This process includes proof of ISO 13485, valid business/manufacturing licenses, site master file, certified GMP documentation, and more.
Typical timeline for manufacturer/site renewal:
📆 2 – 4 weeks
Fees are higher (around 10,000 AED plus application).
Key Takeaways & Best Practices
✔️ Start Renewal Early
Initiate at least 3 months before expiry.
✔️ Document Readiness
Follow the checklist carefully — especially post-market reports and conformity certificates.
✔️ Follow Portal Guidance
Use the MOHAP/EDE portals and UAE PASS for secure authentication and submission.
✔️ Maintain Valid Licenses
Your warehouse/marketing authority license must be active without lapses.
Final Thoughts
Medical device registration renewal in the UAE is a structured, regulated, and document-driven process that carries real legal and commercial implications. By understanding the authorities involved, compliance with timelines, documentation requirements, and fees, you can streamline renewals — avoid rejection — and safeguard long-term market access.
