Omar H.
Startup Founder
“From licence selection to banking support, Takween gave us a clear path and helped us avoid delays we would have hit on our own.”
Medical Device Registration in Dubai – Get Your Devices Approved Legally
Free Consultation / Register Your Medical Device Today
If you plan to import, manufacture, or sell medical devices in the UAE, medical device registration in Dubai is mandatory. Dubai Health Authority (DHA) and Ministry of Health & Prevention (MOHAP) require all medical devices to meet UAE safety and quality standards before being marketed. Takween offers expert medical device registration services in Dubai, ensuring smooth approvals and compliance with the local regulatory framework.
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What type of medical device are you registering?
Each product type follows a slightly different registration pathway in the UAE.
Why Medical Device Registration Matters in Dubai
Legal Requirement for Market Entry
All medical devices must be registered with the UAE Ministry of Health and Prevention (MoHAP) before they can be imported, marketed, or sold in Dubai and the UAE.
Ensure Safety & Compliance
Registration confirms your device meets UAE safety, quality, and performance standards — especially important for high-risk products.
Five-Year Validity & Renewals
Approved medical device registrations are typically valid for 5 years and must be renewed before expiration.
Supports Import & Distribution
Only registered devices can obtain an import permit and clear customs for sale across Dubai and the wider UAE.
Risk Classification Determines Process
Devices are classified (e.g., Class I, IIa, IIb, III) based on risk level, which influences registration requirements and review intensity.
Step-by-Step Medical Device Registration Process
Step 1: Classify Your Device
Determine your device’s risk class (Class I–III or active implantable) based on intended use, invasiveness, and risk profile.
Step 2: Appoint a Local Representative
Foreign manufacturers must work with a UAE-based Authorized Representative (Marketing Authorization Holder) or distributor to submit the application.
Step 3: Prepare Required Documents
Typical documents include: • Product description, specifications & intended use • Quality system certification (e.g., ISO 13485) • Certificates of conformity (e.g., CE/FDA), free sale documents • Safety & efficacy data (especially for higher-risk devices) • Labelling and user manuals (English/Arabic)
Step 4: Submit Application via MoHAP Portal
Log in with UAE PASS and submit your dossier through MoHAP’s online platform, upload documentation, and pay the applicable fees.
Step 5: Technical Review & Committee Evaluation
MoHAP’s technical committees assess your submission; they may request additional information, tests, or clarifications during review.
Step 6: Receive Registration Certificate
Once approved, MoHAP issues the medical device registration certificate — allowing legal marketing and distribution in Dubai/UAE. The certificate is typically valid for 5 years.
TESTIMONIALS
What Clients Say About Takween Advisory
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Mariam A.
SME Owner
“Their team made the compliance side simple. We always knew what was next, what was required, and how to stay on schedule.”
James T.
Consultancy Director
“Takween handled our setup with speed and precision. The communication was consistent, and every step felt organized and well managed.”
Leila R.
International Investor
“What stood out was the practical guidance. They did not just explain options, they recommended the structure that actually fit our goals.”
Ana Maria C.
Business Owner
“Takween made the setup process feel structured from day one. Every document, approval, and next step was handled with clarity.”
Luka P.
Founder
“What I valued most was how fast the team moved. They helped us avoid delays and kept the launch timeline under control.”
Mark D.
Managing Partner
“Their advice was practical, not generic. We got a setup route that fit our goals and the execution was smooth throughout.”
Mila S.
Operations Lead
“The communication was consistent and precise. We always knew what was pending, what was approved, and what came next.”
Peter N.
International Consultant
“Takween handled the process with confidence and speed. It saved us time internally and gave us much more certainty.”
Sofia A.
Investor
“They explained the tradeoffs clearly and helped us choose the right structure without wasting time on the wrong options.”
Nadia R.
E-commerce Founder
“The process felt organized from start to finish. Takween helped us launch quickly while keeping the compliance side under control.”
Karim S.
SME Director
“We came in with a lot of uncertainty and left with a clear plan. The team was responsive, practical, and easy to work with.”
WHAT IS INCLUDED
What your device registration covers
Risk-class determination
Each device is graded against the Class I, IIa, IIb, and III framework, because that single decision sets how much technical and clinical evidence DHA and MOHAP will expect to see.
Quality-system verification
Your ISO 13485 certification and quality-management evidence are verified up front, since the device file rests on a recognised quality system rather than the product alone.
Conformity-marking reconciliation
CE marking, FDA clearance, or equivalent conformity certificates are assembled and reconciled with ESMA's conformity expectations for the device category.
Technical file and IFU build
Device specifications, manufacturing detail, and the bilingual instructions-for-use are compiled into the technical file the reviewers read end to end.
Establishment and product listing
Establishment registration and the device listing are completed through the DHA and MOHAP portals so both the supplier and the product are recognised.
Clinical-evidence handling
For higher-risk classes we organise the risk assessment and clinical evaluation the authority requires before it will accept the device for market.
HOW IT WORKS
From classification to an approved device
A medical device clears on its conformity assessment and technical file, so this path grades the device, proves the quality system behind it, and assembles the evidence before either authority begins its review.
01
Classification
The device's intended use and risk are assessed to place it in the correct class, which defines the registration route and evidence depth.
02
Quality and conformity review
ISO 13485 status and CE or FDA conformity evidence are checked and matched to the device category before anything is lodged.
03
Technical-file compilation
Specifications, manufacturing data, and instructions-for-use are drawn together into a coherent technical file in Arabic and English.
04
Clinical evaluation for higher classes
Where the class demands it, the risk assessment and clinical evaluation are prepared so the safety case stands on its own.
05
Portal submission and conformity assessment
Establishment registration and the device listing are submitted through DHA and MOHAP, and we manage the conformity-assessment queries that follow.
06
Certificate and distribution clearance
On issuance of the device registration certificate the product is cleared to import, sell, and distribute across the UAE healthcare market.
DOCUMENTATION
The device technical file we assemble
Licence and supplier authorisation
A valid UAE trade licence and a manufacturer authorisation letter establish your right to register and supply the device.
ISO, CE, and FDA certificates
ISO 13485 certification together with CE marking or FDA clearance evidences the quality system and conformity behind the device.
Device technical specifications
Detailed specifications and manufacturing information describe what the device is and how it is built.
Bilingual instructions-for-use
Instructions-for-use in Arabic and English are required so clinicians and users can operate the device safely.
Risk assessment and clinical evaluation
For higher-risk devices a risk assessment and clinical evaluation, with trial data where applicable, support the safety case.
Quality-management documentation
Quality-management-system records evidence the controls that keep production consistent across the device's life on market.
TIMELINES AND COST DRIVERS
Timing, fees, and what delays a device file
What the timeline depends on
A Class I device with clean conformity evidence moves quickly, while higher classes take longer because the clinical evaluation and conformity assessment carry more weight in the review.
- Classification and quality-system check
- Technical-file compilation
- Conformity assessment and authority review
What drives the fee
Cost scales with the device's risk class and SKU count, plus any testing or conformity certification the category requires, since each class carries its own registration burden.
- Device class and SKU count
- Testing and conformity certificates
- Government and regulatory fees per category
What sends a device back
Device files most often stall on an unrecognised quality system, missing instructions-for-use, or clinical evidence that does not match the device's risk class.
- Quality system the authority cannot verify
- Missing or non-bilingual instructions-for-use
- Clinical evidence below the class requirement
WHAT WE COVER
Where our device-registration support extends
Borderline-classification calls
When a device sits between two classes we argue the placement the evidence supports, so you are neither over-burdened nor refused for under-documentation.
IVD and specialist categories
In-vitro diagnostics, dental, and orthopaedic devices carry their own evidence quirks, which we account for rather than treating every device as one template.
Establishment-and-product alignment
We keep the establishment registration and the individual device listings consistent so a supplier-level gap does not block a product approval.
Vigilance and renewal continuity
After approval we keep you aligned with adverse-event reporting and the renewal cycle a registered device requires, protecting the listing over time.
What Is Medical Device Registration in Dubai?
Medical device registration in Dubai is the official approval process for legally importing or selling medical equipment, devices, and healthcare products in the UAE. Registration ensures your devices comply with UAE regulatory standards, patient safety norms, and labeling requirements. This process is similar to FDA device registration in the United States but tailored to UAE regulations. Takween manages the entire medical device registration process in Dubai, from documentation to final approval, guiding you through the regulatory pathway.
Types of Medical Devices That Require Registration in Dubai You must complete medical device registration in Dubai for:
- Diagnostic devices (imaging, lab instruments)
- Surgical instruments & equipment
- Hospital furniture & medical furniture
- Wearable medical devices & monitors
- In-vitro diagnostic (IVD) products
- Dental & orthopedic devices
- Consumables & disposables used in medical procedures
Each product is classified according to risk-based categories (Class I, IIa, IIb, III) in the medical device register. Understanding the medical device nomenclature is crucial for proper classification.
Medical Device Registration Authority in Dubai Medical devices are regulated by:
- Dubai Health Authority (DHA)
- Ministry of Health & Prevention (MOHAP)
- Emirates Authority for Standardization & Metrology (ESMA) (for conformity)
These authorities work together to implement the UAE's medical device directive and regulatory framework. Takween coordinates directly with these authorities to ensure fast and compliant approvals.
Medical Device Registration Process in Dubai
Our streamlined process for medical device registration in Dubai includes:
- Product classification based on risk category using the product
classification database
- Review of technical documentation & compliance certificates
- Labeling verification (Arabic & English)
- Online submission via DHA / MOHAP portals for establishment registration
- Conformity assessment and authority review
- Issuance of medical device registration certificate
We handle all authority communications, premarket submissions, and follow-ups throughout the regulatory pathway.
UAE Medical Device Compliance Requirements
To meet medical device registration requirements in Dubai, products must comply with:
- ISO 13485 / CE / FDA certifications (if applicable)
- UAE labeling and safety standards
- Instructions for use in Arabic & English
- Device specifications, manufacturing details, and shelf life
- Risk assessment & clinical evidence (for higher-risk devices)
- Quality management system implementation
- Good manufacturing practices adherence
- Design controls documentation
- Adverse event reporting procedures
- General controls and special controls (if applicable)
- Quality system regulation compliance
Non-compliance can lead to rejection or delayed approval.
Medical Device Registration Cost in Dubai The cost of medical device registration in Dubai depends on:
- Device classification (Class I, II, III)
- Number of products or SKUs
- Required testing and conformity certificates
- Government and regulatory fees
- Device registration fees specific to each category
Takween provides transparent pricing with no hidden charges, detailing all device listing requirements and associated costs.
Documents Required for Medical Device Registration in Dubai To register medical devices in Dubai, you typically need:
- Valid UAE trade license
- Manufacturer authorization letter
- Device technical specifications
- ISO / CE / FDA certificates
- Labeling artwork (Arabic & English)
- Risk assessment & clinical evaluation documents (if required)
- Clinical trial data (for certain device categories)
- Quality management system documentation
- Premarket submission materials
Our consultants ensure all documentation meets regulatory standards and device listing requirements.
Benefits of Medical Device Registration in Dubai Registering medical devices in Dubai provides:
- Legal approval to sell and distribute in the UAE
- Compliance with DHA & MOHAP safety and effectiveness standards
- Smooth customs clearance
- Consumer trust and market credibility
- Protection against regulatory fines or recalls
- Alignment with global medical device directives
Proper registration ensures both legal compliance and patient safety within the UAE's regulatory framework.
Why Choose Takween for Medical Device Registration in Dubai?
Businesses trust Takween for:
- Experienced regulatory and compliance experts
- Fast-track medical device approvals
- End-to-end submission and follow-up services
- Liaison with DHA, MOHAP, and ESMA
- Dedicated consultants for each device category
- Expertise in navigating the regulatory pathway
- Assistance with quality system regulation implementation
Register Your Medical Devices in Dubai Today
Ensure your medical devices are fully compliant with UAE regulations with professional medical device registration services in Dubai.
Book a Free Consultation Today
Contact Takween now to start your medical device registration in Dubai and enter the UAE healthcare market confidently. Our team will guide you through the entire process, from initial assessment to final approval, ensuring your medical device establishment meets all regulatory requirements.
Get your medical device cleared for the UAE
Send Takween Advisory your ISO 13485 certificate, conformity evidence, and device specifications, and we will grade the risk class and run the DHA, MOHAP, and ESMA submission through to a device registration certificate.