Starting a medical equipment trading company in Dubai involves obtaining a DET trade license, securing approvals from MOHAP/EDE 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. Valued at USD 3.8 billion in 2024, the medical devices market is projected to grow at a CAGR of 8.87% through 2030, fueling massive demand for advanced medical equipment. 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 medical tourism sector aiming for 1 million visitors by 2030 — ensuring consistent, high-value demand.
- 100% Foreign Ownership: UAE law allows 100% foreign ownership for mainland companies in this sector.
- Strategic Global Location: Access to Middle East, Africa, Asia, and Europe via world-class logistics.
- High-Profit Margins: Premium pricing for certified, advanced equipment.
Critical Regulatory Update for 2026: The EDE Era
Under Federal Decree-Law No. 38/2024, a major change is underway. After the grace period ending on January 2, 2026, the Emirates Drug Establishment (EDE) will be the centralized federal authority for:
- Medical product approvals and imports.
- Pharmacovigilance and post-market surveillance.
- Risk-based (Class A–D) classification.
Action Item: Prepare now with full ISO 13485 and GSDP (Good Storage and Distribution Practices) compliance to ensure a smooth transition and avoid delays.
Step-by-Step Process to Launch Your Company (2026 Ready)
Follow this linear process to establish your compliant medical equipment trading company.
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 a Legal Structure: Typically, a Limited Liability Company (LLC) with 100% foreign ownership.
- Select and Approve a Trade Name: Secure a unique name with the Department of Economy and Tourism (DET).
- Apply for Initial Approval: Submit your preliminary application to the DET.
- Secure a Physical Office and Warehouse: A commercial office is mandatory. For product registration, you will need a GSDP-compliant warehouse (minimum ~2,000 sq ft, with temperature/humidity control, security, etc.).
- Obtain Your Trade License: Finalize all documents, including the tenancy contract, and pay the fees to receive your license.
Step 2: Obtain Your DET Trade License
Finalize your documents (including tenancy contracts) and pay the required fees to receive your formal trade license from the DET.
- Professional Tip: Choose your business activity carefully (e.g., “Medical, Surgical Articles and Requisites Trading” vs. “Medical, Surgical Equipment, and Instruments Trading”).
Step 3: Secure Regulatory Approvals & Company Registration
This is the most critical phase for compliance.
- Register with EDE (formerly MOHAP): Register your company and all medical devices with the EDE before any import or sale. This requires an attested ISO 13485:2016 certificate.
- Obtain a Warehouse License: Your facility will undergo a GSDP compliance inspection by the EDE. Upon passing, you will receive a warehouse license.
- Register with Dubai Health Authority (DHA): This is mandatory to sell your products within the Emirate of Dubai. (Note: Other emirates have their own health authorities).
Step 4: Product Registration and Market Entry
With your company approved, the focus shifts to your products.
- Prepare Product Dossiers: Compile detailed technical files for each device, including intended use, CE/FDA certificates, Free Sale Certificates, etc. (all legally attested).
- Submit for EDE and DHA Approval: The EDE review is risk-based (Class A–D). Low-risk approvals take 1-3 months; high-risk can take up to 6 months.
- Register with Dubai Customs: Obtain your import/export code to begin logistics operations.
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 (office + warehouse)
- Legalized/attested ISO 13485:2016 certificates (by UAE Embassy if foreign issued)
- Attested product certificates (CE, FDA, Free Sale Certificate, etc.)
- Product liability and public liability insurance
- UAE PASS login credentials (for e-submissions)
Cost of Starting a Medical Equipment Trading Company in Dubai
A realistic starting budget is AED 25,000 – 60,000 (excluding warehouse rent and multi-product registrations)
| Item | Approximate Cost (AED) |
|---|---|
| DET Trade License | 21,000* – 25,000* |
| MOHAP/EDE Fees (per device) | 5,000 – 5,500 + classification |
| Certification & Attestation | 5,000 + |
| Consultancy Fees | 5,000* – 10,000* |
| Warehouse Rent (GSDP-compliant) | 50,000+ per year (excluded above) |
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 or non-attested technical files.
- Solution: Pre-audit all documents with your manufacturer and a consultant before submission.
Issue 2: Warehouse Compliance Failure
- Cause: Failing GSDP standards (temperature control, size, security).
- Solution: Lease a pre-approved medical warehouse or work with an expert to ensure your facility meets all requirements before inspection.
Issue 3: Confusion Between Authorities
- Cause: Overlapping mandates between EDE (federal) and DHA (local).
- Solution: Partner with a consultant who can map the exact requirements for your target markets.
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
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/EDE 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 AED 25,000* to 60,000*, depending on office/warehouse space, number of products, and EDE fees. 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 gives you strategic entry into one of the world’s fastest-growing healthcare markets. With full EDE implementation under Federal Decree-Law No. 38/2024 by the end of 2026, the process is becoming more centralized and efficient — provided you meet the enhanced compliance standards from day one.
By following this 2026-ready guide and partnering with experts like Shuraa Business Setup, you can establish a fully compliant, profitable business in the heart of the UAE’s medical trade landscape.
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
Disclaimer: Information is accurate as of November 2025 and reflects ongoing implementation of Federal Decree-Law No. 38/2024 (full transition by January 2026). Regulations can change; always consult Shuraa Business Setup for the latest tailored advice before proceeding.
