Medical Device Registration in Dubai – Get Your Devices Approved Legally
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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.
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.
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.