Starting a medical equipment trading company in Dubai involves obtaining a DET trade license, securing approvals from MOHAP and DHA, registering your products, and ensuring ISO 13485 certification and a compliant warehouse. This guide provides a clear, step-by-step process to navigate the legal and regulatory landscape for 2026 and beyond.
The UAE’s healthcare sector is a beacon of excellence, continuously expanding with state-of-the-art hospitals and clinics. This growth fuels a massive demand for advanced medical equipment, creating a lucrative opportunity for entrepreneurs. Establishing a medical equipment trading company in Dubai places you at the heart of this dynamic market.
This definitive guide provides a clear, step-by-step blueprint to legally establish your business, covering licensing, regulatory approvals, and the critical role of expert consultants like Shuraa Business Setup.
Why Start a Medical Equipment Trading Company in Dubai?
Dubai offers a uniquely advantageous environment for your medical equipment business:
- Thriving Healthcare Hub: Home to world-class hospitals and a growing medical tourism sector, ensuring consistent, high-value demand.
- 100% Foreign Ownership: UAE law now allows 100% foreign ownership for mainland companies in most sectors, including medical equipment trading. You can fully own your company without a local partner.
- Strategic Global Location: Access markets across the Middle East, Africa, Asia, and Europe with world-class logistics and infrastructure.
- High-Profit Margins: The focus on quality and advanced technology in UAE healthcare allows for premium pricing for certified equipment.
Step-by-Step Process to Start Your Medical Equipment Business
Navigating the setup process correctly from the start is crucial for compliance and success.
Step 1: Business Registration and Licensing with DET
Your first official step is to legally register your company and obtain a trade license from the Department of Economy and Tourism (DET), formerly known as the DED.
- Choose Your Legal Structure: Most businesses opt for a Limited Liability Company (LLC). Under the updated laws, you can own 100% of your mainland LLC.
- Select a Trade Name: Choose a unique name and get it approved by the DET.
- Apply for Initial Approval: Submit your initial application to the DET, signaling the government’s preliminary consent for your business.
- Secure a Physical Office & Warehouse: A commercial office is mandatory. For MOHAP registration, you will also need a warehouse that meets specific standards.
- Obtain Your Trade License: Finalize all documents, including the tenancy contract, and pay the fees to receive your license.
Professional Tip: The DET offers specific business activities for this field. Choose carefully between Medical, Surgical Articles, and Requisites Trading and Medical, Surgical Equipment, and Instruments Trading.
Step 2: Obtain Regulatory Approvals and Certifications
This is the most critical phase, determining your ability to legally sell your products.
- Register with MOHAP: The Ministry of Health and Prevention (MOHAP) is the federal authority. You must register your company and each individual medical device with MOHAP before you can import and sell them.
- Register with DHA: If you plan to sell to facilities in Dubai, you must also register with the Dubai Health Authority (DHA). Other emirates have their own health authorities (e.g., DOH in Abu Dhabi).
- Secure ISO 13485 Certification: A notarized ISO 13485 certificate for your medical devices is a mandatory requirement for product registration, proving your quality management system meets international standards.
- Get a Warehouse License: After a physical inspection, MOHAP will issue a warehouse license certifying your storage facility meets the required standards for medical equipment.
Step 3: Product Registration and Compliance
With your company approved, the focus shifts to your products.
- Prepare a Detailed Product Dossier: For each device, you must submit a comprehensive file including:
- Product catalogs, images, and descriptions
- Intended use and instructions
- Country of origin and manufacturing details
- Free Sale Certificate from the country of origin
- Certificates like CE Marking, FDA approvals, etc.
- Submit for MOHAP/DHA Approval: The health authorities will review your dossiers. This process can take several months.
- Register with Customs: Obtain an import/export code from Dubai Customs to facilitate your shipments.
Common Issues and How to Overcome Them
Entrepreneurs often face these hurdles. Being prepared is key to a smooth setup.
Issue 1: Product Registration Rejection
- Cause: Incomplete technical files or non-compliant certifications.
- Solution: Work with your manufacturer to ensure all documents (ISO 13485, CE, Free Sale Certificate) are complete, notarized, and attested as per MOHAP requirements. Shuraa can pre-audit your documents to prevent delays.
Issue 2: Warehouse Compliance Failure
- Cause: The storage facility does not meet MOHAP’s standards for temperature control, hygiene, or security.
- Solution: Secure your warehouse through a reputable agent who understands MOHAP’s specific requirements for medical device storage before the inspection.
Issue 3: Confusion Between Authorities
- Cause: Uncertainty about whether you need MOHAP, DHA, or both approvals.
- Solution: As a rule of thumb, MOHAP is federal and generally required for import. DHA is local and required to sell within Dubai. A business setup expert can map out the exact approvals you need based on your target market.
Documents Required to Start Your Medical Equipment Company
Having the correct documents ready will streamline the process:
- Passport copies of all shareholders
- Visa copies (if residing in the UAE)
- Company profile and business plan
- Detailed list of products to be traded
- Tenancy contract for office and warehouse
- ISO 13485 certificates for the products
- Product catalogs and quality certificates (CE, FDA)
- Proof of insurance (public liability, etc.)
Cost of Starting a Medical Equipment Trading Company in Dubai
The total cost is variable and depends on several factors:
- DET License Fees: The base cost for the trade license.
- Office & Warehouse Rental: A significant recurring cost, with warehouse standards impacting the price.
- MOHAP/DHA Fees: Government fees for company and product registration.
- Certification Costs: Fees for obtaining and notarizing ISO 13485 and other certificates.
- Consultancy Fees: The cost for expert guidance from a setup consultant like Shuraa.
A realistic starting budget for a compliant company, including initial licenses and basic MOHAP registration, is approximately AED 20,000* to AED 50,000* and more, excluding high warehouse rents and extensive product registration.
Why Choose Shuraa Business Setup?
The path to launching your medical equipment trading company is complex, with zero room for error in regulatory compliance. Shuraa Business Setup is your ideal partner for a seamless and successful setup.
We offer:
- End-to-End Service: We manage the entire process, from DET licensing and office sourcing to MOHAP/DHA registration and product filing.
- Sector-Specific Expertise: Our team has in-depth experience in the healthcare sector and understands the nuances of medical device regulations.
- Time and Cost Efficiency: We streamline the process, avoiding costly delays and rejections by ensuring all submissions are complete and compliant.
- Dedicated Consultant: You will have a single point of contact, providing clear communication and support at every step.
Ready to launch your venture in one of the world’s most dynamic markets? Contact Shuraa today for a free, no-obligation consultation.
Call: +97144081900 | WhatsApp: +971507775554 | Email: info@shuraa.com
Frequently Asked Questions (FAQs)
1. Do I need a license to sell medical supplies in the UAE?
Yes. You need a commercial trade license from the DET to operate the company. Crucially, you also need to register your company and products with MOHAP and other health authorities (like DHA) to legally sell to healthcare facilities.
2. How much does it cost to start a medical supply business?
Costs start from approximately AED 20,000 but can rise significantly based on office/warehouse space and the number of products you register with MOHAP. It’s best to get a customized quote based on your specific business plan.
3. Is selling medical equipment a good business in Dubai?
Absolutely. The continuous expansion of the UAE’s healthcare infrastructure and its focus on becoming a global medical hub create a sustained and high-demand market for quality medical equipment.
4. Can I own 100% of my medical equipment trading company?
Yes. Under the updated UAE Commercial Companies Law, 100% foreign ownership is permitted for mainland companies in the medical equipment trading sector, allowing you full control and profit share.
Conclusion
Starting a medical equipment trading company in Dubai represents a strategic entry into one of the world’s most dynamic and rapidly growing healthcare markets. While the process involves multiple crucial steps—from securing your DET trade license and 100% company ownership to navigating MOHAP and DHA product registrations—each phase brings you closer to establishing a compliant and profitable business.
The key to success lies in understanding the regulatory landscape, preparing thorough documentation, and maintaining strict compliance with UAE’s healthcare standards. While the path may seem complex, the potential rewards of operating in this premium market make the effort worthwhile.
With Dubai’s healthcare sector continuing its expansion toward 2026 and beyond, there has never been a better time to establish your presence in this vital industry. By following this comprehensive guide and leveraging expert support from Shuraa Business Setup, you can confidently navigate the setup process and position your company for long-term success in the heart of the UAE’s medical trade landscape.
Read Also
- 100% Foreign Ownership in UAE Mainland
- Free Zone vs Mainland Dubai: Explained
- How to Get a UAE Residence Visa in 2026
- Trade License in Dubai: A Complete 2026 Guide
Disclaimer: The information provided in this blog is for general guidance and informational purposes only. It does not constitute legal, financial, or professional advice. While we strive to keep the content accurate and up-to-date, UAE business regulations are subject to change. We recommend consulting with our expert consultants at Shuraa Business Setup for the most current advice tailored to your specific situation before taking any action.
