Verified client feedback · 4.6 from 125 Google reviews · verified 31 July 2026
Medical Device Registration in the UAE (2026)
We assist in registering medical devices and cosmetics, facilitating their lawful import and distribution within the UAE.
Overview
Importing medical devices and cosmetics into the UAE requires navigating complex regulatory frameworks. Spectronix manages the entire registration process with MOH, ensuring your products meet all safety and quality standards for lawful import, distribution, and sale within the UAE market. Our regulatory affairs team has deep experience with UAE product classification, technical documentation, and post-market surveillance requirements.
You cannot import, sell or install a device without federal registration
To import, distribute or sell a medical device or cosmetic in the UAE it must be registered federally. That includes clinics buying new equipment — not just manufacturers and distributors.
2026 update: device services have moved from MOHAP to the Emirates Drug Establishment (EDE), which is now the sole federal authority for classification, market authorisation, import permits, manufacturer licensing and post-market vigilance. A new EDE policy also requires more than one agent per product.
Who needs to register
- Manufacturers placing devices on the UAE market
- Importers and distributors bringing devices in
- Clinics and hospitals purchasing new equipment that isn't already registered
- Cosmetic brands entering the UAE retail or clinical channel
The EDE registration process, step by step
- 1. Appoint a UAE Local Authorised Representative licensed as a medical store or scientific office (a scientific office alone cannot import or distribute directly).
- 2. Classify the device — Class I, IIa, IIb or III per the IMDRF framework.
- 3. Compile the technical dossier: manufacturer approvals, ISO 13485, free-sale certificate, declaration of conformity, labelling and instructions for use, prior CE/FDA approvals.
- 4. Submit the application via the regulator's online system.
- 5. Certificate issued — valid for 5 years and renewable.
Cost and timeline
- Application fee: approximately AED 100
- Registration fee: approximately AED 5,000
- Class I and II devices: approximately 4–6 weeks
- Class III and IV devices: approximately 8–10 weeks
- Certificate validity: 5 years, renewable
Why registrations get rejected
- Incorrect device classification
- Incomplete or inconsistent technical dossier
- Local representative is not properly licensed for the product type
- Non-compliant labelling or instructions for use
- Missing or expired manufacturer or free-sale certificates
Talk to a Spectronix specialist
Free 30-minute consultation. We'll map your exact next steps.
Related Spectronix guides
Part of complete clinic delivery
Setting up a clinic in Dubai?
This service is one part of the full clinic setup journey. See how Spectronix coordinates feasibility, DHA licensing, design, fit-out, equipment, staffing, inspection and launch.
View the Clinic Setup Dubai GuideWhat's Included
Our Process
Product Classification
We determine the correct regulatory classification and identify the applicable registration pathway.
Technical File Preparation
We compile the complete technical dossier including safety data, clinical evidence, and quality certifications.
MOH Submission
The registration application is submitted to MOH with all required documentation and fees.
Review & Approval
We manage communication with MOH during review, respond to queries, and expedite the approval process.
Import & Distribution
Once approved, we assist with import permits, customs procedures, and distribution channel setup.
Why Choose Spectronix
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Important Disclaimer
The information on this page is for general guidance only and does not constitute professional, legal, or medical advice. Results may vary based on individual circumstances. Always consult qualified professionals for personalized advice.
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What Spectronix clients say
Verified client feedback from clinic owners and healthcare professionals we have supported in Dubai and the UAE.
We have been working with this company for quite some time, and they have consistently exceeded our expectations. Their team is highly professional, knowledgeable, and efficient. They truly know their job and always deliver high-quality work on time. Communication is smooth, and every project is handled with great attention to detail. We highly recommend them to anyone looking for reliable professionals. Thank you for your excellent service!
Great and reliable team highly recommend
Great experience with Spectronix Consultancy. The staff are very helpful and quick to assist whenever needed. Fast service and good communication. Highly recommended!
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Client feedback before you book
4.6 from 125 Google reviews · verified 31 July 2026
Very helpful and professional employees, Great company!
Great company! Very supportive, trustable with highly qualified professionals. They always deliver the service punctually and effectively. Highly recommended!
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