Business Setup

Dubai in 2026 is one of the most attractive places in the world to build a medical trading and healthcare support business, thanks to strong demand, clear regulations, and full foreign ownership in key activities.

Why Dubai’s Medical & Healthcare Support Sector Is So Attractive

The UAE’s healthcare sector continues to expand with new hospitals, clinics, and specialized centers, driving constant demand for medical devices, consumables, and technical support services. The medical devices market alone was valued at USD 3.8 billion in 2024 and is projected to grow at a CAGR of around 8.87% through 2030, giving serious investors a long runway for growth.

For medical trading specifically, Dubai offers:

• A healthcare hub serving both residents and medical tourists.
• 100% foreign ownership for mainland medical equipment trading companies.
• Strategic access to the Middle East, Africa, Asia, and Europe via world-class logistics networks.
• The ability to command premium margins on certified, advanced equipment and specialist services.

For healthcare support businesses (maintenance, IT, EMR support, remote monitoring, etc.), this same ecosystem creates recurring, long-term B2B opportunities with hospitals, clinics, labs, and wellness providers.

The New Regulatory Reality: The EDE Era (2026)

From 2 January 2026, the Emirates Drug Establishment (EDE) will become the centralized federal authority for medical products, replacing and consolidating previous MOHAP functions. Under Federal Decree-Law No. 38/2024, EDE is responsible for: 

• Medical product approvals and imports.
• Pharmacovigilance and post-market surveillance.
• Risk-based device classification (Class A–D). 

For you as an entrepreneur, this means you must plan your setup around EDE requirements from day one, especially if you are trading or distributing medical devices. 

Action point: Ensure your business is ready with ISO 13485:2016 and full GSDP (Good Storage and Distribution Practices) compliance so that company and warehouse approvals are not delayed in 2026.

What Type of Business Can You Build?

You can position yourself anywhere along the value chain, or combine models for better revenue diversification:

• Medical equipment and device trading (capital equipment, diagnostic devices, ICU/OR equipment, home‑care devices).
• Medical disposables and consumables trading (surgical disposables, lab consumables, dental supplies, single-use items).
• Healthcare support services (equipment installation, calibration, maintenance contracts, biomedical engineering support, IT/EMR implementation, coding and billing support).
• Hybrid models that blend trading with after-sales service and technical support to build long-term contracts.

The core compliance framework (DET trade license, EDE registration, DHA registration, where applicable, warehouse compliance) applies to medical trading businesses, but many healthcare support activities can be added under compatible license structures when planned properly.

Step-by-Step: How to Launch a Medical Equipment Trading & Healthcare Support Company

Below is a practical, 2026-ready roadmap based on how we structure setups for clients.

Step 1: Business Registration and Licensing with DET

Your first task is to obtain a trade license from the Department of Economy and Tourism (DET). Typically, you will:

• Choose a legal structure – usually a mainland LLC with 100% foreign ownership for medical equipment trading. 
• Select and reserve a trade name with DET.
• Apply for initial approval for your chosen activity.
• Secure a physical office in Dubai (mandatory for licensing).
• Plan for a GSDP-compliant warehouse if you will import and store devices (minimum around 2,000 sq ft with temperature and humidity control, security, and proper layout).

Once your documents and tenancy contracts are complete, DET issues the trade license.

Professional tip: Choose the precise activity wording carefully (e.g., “Medical, Surgical Equipment and Instruments Trading” vs “Medical, Surgical Articles and Requisites Trading”) so it matches your actual product range and future regulatory requirements.

Step 2: Obtain and Finalize Your DET Trade License

At this stage, you:

• Finalize all incorporation documents, shareholder details, and tenancy contracts.

Pay DET fees and receive your official trade license.

This license is the basis upon which all EDE and DHA approvals will sit.

Step 3: Secure Regulatory Approvals & Company Registration (EDE + DHA)

This is the most compliance-heavy phase, and where many entrepreneurs need expert guidance.

• Register your company with the Emirates Drug Establishment (EDE) before importing or selling any medical device.
• Obtain and legalize an ISO 13485:2016 certificate (attested if issued abroad); this is mandatory for EDE company registration.
• Prepare your warehouse for a GSDP inspection; EDE will inspect your facility for storage, environment, security, and documentation standards.
• Once you pass, EDE issues a warehouse license, allowing you to hold and distribute medical products.
• Register with the Dubai Health Authority (DHA) if you plan to sell medical products within Dubai or integrate with clinical operations; other emirates will rely on their own health authorities.

If you are also offering technical or healthcare support services attached to equipment (maintenance, calibration, training), these can be layered into your structure depending on your chosen activities and contracts.

Step 4: Product Registration and Market Entry

With your company and warehouse approved, the focus shifts to your products and market launch.

• Prepare detailed product dossiers for each device, including intended use, CE/FDA approvals, Free Sale Certificates, risk classification, and technical documentation (all properly legalized and attested).
• Submit devices to EDE for risk‑based review (Class A–D); low‑risk devices may see approval in 1–3 months, while higher‑risk items can take up to 6 months.
• Complete any associated DHA product registrations where required by your target customer segment in Dubai.
• Register with Dubai Customs and obtain an import/export code to start importing and re‑exporting products regionally.

Once approvals are in place, you can begin selling to hospitals, clinics, labs, pharmacies, and other healthcare operators.

Documents and Budget You Should Plan For

Key Documents Required

To avoid delays, prepare your documentation early:

• Passport copies of all shareholders.
• Visa copies (if you reside in the UAE).
• Company profile and business plan.
• Detailed list of products you plan to trade.
• Tenancy contracts for your office and warehouse
• Legalized/attested ISO 13485:2016 certificate (especially if issued abroad).
• Attested product certificates: CE, FDA, Free Sale Certificates, etc.
• Product liability and public liability insurance policies.

UAE PASS credentials to manage e‑submissions to authorities.

Realistic Startup Costs

A realistic baseline to start a medical equipment trading company in Dubai is around AED 25,000–60,000, excluding warehouse rent and multi-product registration fees.

Typical cost components include:

DET trade license: approx. AED 21,000–25,000 (depending on structure and add-ons).

• EDE fees per device: around AED 5,000–5,500 plus classification costs.
• Certification and attestation: from AED 5,000 upwards.
• Consultancy and professional fees: approx. AED 5,000–10,000, depending on scope.
• Warehouse rent for a GSDP-compliant facility: from about AED 50,000 per year and above (often excluded from initial licensing estimates).

Building a parallel healthcare support function (e.g., maintenance contracts, IT support) will require additional staff and possibly specific professional backgrounds but does not dramatically change the licensing cost framework if structured correctly.

Common Pitfalls – And How to Avoid Them

Drawing from typical cases in this sector, three issues come up again and again:

• Product registration rejection
  • Cause: Incomplete, non-attested, or inconsistent technical documentation from manufacturers.
  • Solution: Pre‑audit all files with your manufacturer and a consultant before submission; ensure every certificate is properly legalized and matches the device configuration you will import.​
• Warehouse compliance failure
  • Cause: Leasing a generic warehouse that cannot meet GSDP standards (temperature control, security, layout, monitoring).
  • Solution: Either lease a pre‑approved medical warehouse or design your facility with GSDP in mind from day one, working with a specialist to pass inspection on the first attempt.
• Confusion between authorities (EDE vs DHA and others)
  • Cause: Misunderstanding which approvals relate to products, which relate to facilities, and which relate to professionals.

Solution: Use a clear regulatory map for your specific model (trading, support services, or hybrid) and sequence approvals correctly so you are not blocked at customs or during tenders.

How Gulf Central can Helps You Win

In a tightly regulated space like medical trading and healthcare support, a 15-year‑experienced consultant’s role is not just form-filling; it is strategic design and risk reduction.

A good consultant will:

• Help you pick the right activities, structure, and jurisdiction so your license supports both medical trading and healthcare support services without future restructuring.
• Plan your EDE, DHA, and DET steps so you do not pay twice or wait unnecessarily.
• Guide you on ISO 13485, GSDP warehouse standards, and documentation so your company and products can clear approvals smoothly.
• Build a realistic budget and timeline specific to your product portfolio, markets, and growth plans.