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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device

What type of medical device are you registering?

Each product type follows a slightly different registration pathway in the UAE.

Dubai Economy
Government of Dubai
IFZA - International Free Zone Authority
SPC Free Zone
Shams - Sharjah Media City
Dubai Police
RTA - Roads and Transport Authority
Meydan Free Zone
RAKEZ - Ras Al Khaimah Economic Zone
Federal Tax Authority
Dubai South
Dubai Health Authority
Dubai Economy
Government of Dubai
IFZA - International Free Zone Authority
SPC Free Zone
Shams - Sharjah Media City
Dubai Police
RTA - Roads and Transport Authority
Meydan Free Zone
RAKEZ - Ras Al Khaimah Economic Zone
Federal Tax Authority
Dubai South
Dubai Health Authority

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.

Medical device registration requirements and compliance process for Dubai market approval
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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.

Medical device risk classification flowchart showing Class I through III categories and active implantable device determination process
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TESTIMONIALS

What Clients Say About Takween Advisory

Google
Reviews
5.0 rating based on Google reviews
Saurabh Rawat business setup Dubai Google review testimonial

Saurabh Rawat

Google Review

“I recently used Takween Advisory for my business setup in Dubai, and the entire experience was smooth and professional. Their team guided me through the company formation process step by step and helped me choose the right option between a free zone company and a mainland license based on my business needs. They also handled the visa process efficiently, keeping me informed at every stage. The website clearly explains their services, and the actual support matched what was promised online. I highly recommend Takween Advisory to anyone looking for reliable and hassle-free business setup services in Dubai.”

MM

Melanie Masuangat

Google Review

“I had a very positive experience with Takween Advisory. The team was supportive, professional, and very easy to communicate with throughout the entire process. They handled everything efficiently and made sure that all the information and steps were clearly explained. What stood out the most was their reliability and commitment to providing quality service. Whenever I had questions or needed clarification, they were quick to respond and always helpful. Overall, I'm very satisfied with their service and would gladly recommend Takween Advisory to anyone looking for trustworthy and dependable advisory support.”

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Liana Mariano

Google Review

“Takween Advisory provided exceptional service from start to finish. Their team is knowledgeable, responsive, and truly committed to delivering results. They made the entire process smooth and stress-free. Highly recommend!”

DB

Danilo Bajic

Google Review

“They made everything much easier for me, were always available, patient, and took the time to explain every step in detail. I never felt lost or unsure about what was happening, which made a big difference. Jasser in particular was really great to work with, very helpful, professional, and genuinely a good person. You can tell he actually cares and wants things to go right for you. Overall, it was a really good experience and I'm very satisfied with how everything was handled. I would definitely recommend them.”

GN

Gavin Nieuwenhuys

Google Review

“Takween Business Advisory has a high knowledgeable and professional team. The entire business registration is streamlined from the first step up to completion. Ask these experts... they really provide the best advise!”

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Anais Ait ouakli

Google Review

“Great service and very professional team. They made the business setup process in Dubai simple and fast. Highly recommended!”

MA

Mohammed Amer

Google Review

“Excellent, professional, and efficient, Takween Advisory made our business setup in Dubai smooth and stress-free. Their team provided proactive guidance, clear communication, and handled everything from licensing to visa processing in record time. We highly recommend their expert, reliable, and transparent service to any entrepreneur. They are, * Speed and Efficiency * Professional Expertise * Proactive Communication * Transparency * Comprehensive Support. Once Again I thank Takween Advisory”

AA

Ali Al

Google Review

“My experience with the company was very positive. The team is professional, supportive, and the work environment encourages growth and learning. It is a good place for anyone who wants to develop their skills in real estate and build a successful career.”

SM

Suman Marokky

Google Review

“The Takween Business Advisory team were truly supportive throughout the entire process with remarkable patience and professionalism. From the initial consultation to the final steps, their guidance makes everything much easier and stress-free. The team is knowledgeable, supportive, and always willing to go the extra mile to ensure the best outcome. Highly recommended for anyone looking for trusted guidance in setting up your new business.”

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nana yaa

Google Review

“Professionalism at it's peak. Takween Business Advisory. Trust me, you will be confident and have clarity each step of setting up your business with them.”

Inside the approval scope

What your device registration covers

Risk-class determination process icon

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 process icon

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 process icon

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 process icon

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 process icon

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 process icon

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.

Class to clearance

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
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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
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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
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Technical-file compilation

Specifications, manufacturing data, and instructions-for-use are drawn together into a coherent technical file in Arabic and English.

04
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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
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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
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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.

Medical Device Registration in Dubai process steps with Takween Advisory
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Building the device file

The device technical file we assemble

Licence and supplier authorisation

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, 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

Device technical specifications

Detailed specifications and manufacturing information describe what the device is and how it is built.

Bilingual instructions-for-use

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

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 documentation

Quality-management-system records evidence the controls that keep production consistent across the device's life on market.

Pace, fees & device blockers

Timing, fees, and what delays a device file

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

Beyond the certificate

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.

Where our device-registration support extends
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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.

Register My Medical Device