TRW & Co · Healthcare market entry
Medical Equipment Trading Licence in Dubai
A medical equipment trading licence Dubai companies need is a stack of approvals: a trade licence for the right activity, an Emirates Drug Establishment licence to store and distribute medical products, and a marketing authorisation for each device. This guide, current as of October 2026, explains the sequence, the choice of jurisdiction and the duties that continue after launch.
Key pointSettle who holds each device registration before anything is filed: if a distributor registers devices in its own name and the relationship ends, the manufacturer may be shut out of the market until the file is transferred.
At a glance
EDE is the regulator
The Emirates Drug Establishment grants medical device marketing authorisations and licenses pharmaceutical establishments across the UAE, including in free zones.
2024 law applies
Federal Decree-Law No. 38 of 2024, in force since 2 January 2025, treats medical equipment as medical products needing approval before import or sale.
Trade licence comes first
A mainland licence from the Department of Economy and Tourism or a free zone licence is needed, but it does not authorise selling regulated devices.
Free zones still regulated
Free zone companies need the same EDE approvals; the location mainly changes customs treatment and how onshore customers can be supplied.
Post-market duties continue
Vigilance reporting, recalls, traceability, advertising approval and renewals continue for as long as the devices are on the UAE market.
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Medical equipment trading licence Dubai: the short answer
A medical equipment trading licence Dubai businesses need is really a stack of permissions, not one document. First comes a trade licence for the right activity, issued by the Dubai Department of Economy and Tourism for a mainland company or by a free zone authority. Second, the company must be licensed by the Emirates Drug Establishment (EDE) as a pharmaceutical establishment that may store and distribute medical products. Third, each device must hold an EDE marketing authorisation before it is imported or sold. Import permits, storage standards and post-market duties then apply for as long as the products are on the market.
The commercial licence is usually the fastest step. The regulatory steps take longer and decide whether the business can actually trade. Many founders discover this only after leasing premises and hiring staff, which is why the sequence matters.
This guide, current as of October 2026, explains the legal framework, the choice between mainland, Dubai Healthcare City and other free zones, the licensing and registration process, distribution agreements and the obligations that continue after launch. It reflects the 2024 medical products law, under which the EDE replaced the Ministry of Health and Prevention (MOHAP) as the federal regulator of medical devices.
The legal framework for a medical equipment trading licence Dubai
The 2024 medical products law
Federal Decree-Law No. 38 of 2024 governs medical products, the pharmacy profession and pharmaceutical establishments. It came into force on 2 January 2025 and replaced Federal Law No. 8 of 2019, with a transition period for existing businesses to comply. The law treats medical equipment, including wearable and AI-based products, as medical products. The core rule is that medical products may not be imported, manufactured or sold for circulation without marketing approval.
The law also licenses the businesses in the supply chain. Medical warehouses, storage facilities and marketing offices are pharmaceutical establishments that need a licence, and the law sets duties for vigilance, recalls and advertising.
The Emirates Drug Establishment
The Emirates Drug Establishment was established in 2023 as the federal authority for medical and pharmaceutical products, including medical devices. Its service catalogue covers marketing authorisations for medical devices, renewals, amendments to registered data and manufacturer registration. It regulates across the UAE, including free zones, and has progressively taken over services previously provided by MOHAP. Our guide to medical devices regulation in the UAE explains the approval route in detail.
Other regulators
- Dubai Health Authority. The DHA licenses health facilities and professionals in Dubai. It does not register devices, but hospitals and clinics buying equipment must meet its facility standards.
- Dubai Healthcare City Authority. Regulates healthcare activity inside Dubai Healthcare City, a free zone with its own licensing regime.
- Federal Authority for Nuclear Regulation. FANR licenses equipment that emits ionising radiation, such as X-ray and CT systems, in addition to any EDE approval.
- Customs. Dubai Customs issues the importer code and clears shipments, checking the permits each consignment needs.
Commercial law
Company formation follows the Commercial Companies Law, amended by Federal Decree-Law No. 20 of 2025, in force since late 2025. Foreign investors can generally own mainland trading companies outright, subject to the activity list. Distribution relationships are shaped by Federal Decree-Law No. 3 of 2022 on commercial agencies where an agency is registered, and by general contract law, including the new Civil Transactions Law, in force from 1 June 2026.
Mainland, DHCC or another free zone
The first strategic decision is where to incorporate. The EDE licence and product registrations apply wherever the company sits, so the choice turns on customers, premises and cost.
| Route | Licensing body | Selling to UAE customers | Typical fit |
|---|---|---|---|
| Dubai mainland | Department of Economy and Tourism | Can sell directly to hospitals, clinics, pharmacies and government buyers onshore | Distributors serving the local market and public tenders |
| Dubai Healthcare City | Dubai Healthcare City Authority | Healthcare-focused free zone; onshore sales usually need a mainland channel or the zone's specific permissions | Businesses wanting to sit inside a healthcare cluster |
| Logistics free zones (for example Jebel Ali or Dubai South) | The zone authority | Strong for storage, re-export and regional distribution; onshore sales generally through a mainland distributor | Regional hubs serving the GCC, Africa and South Asia |
| Business and science free zones | The zone authority | Suits regional offices and scientific or marketing functions; onshore supply through licensed importers | Manufacturers' regional offices that appoint local distributors |
A free zone company is not outside the medical products law. It still needs the EDE establishment licence for any regulated storage or distribution, and devices still need marketing authorisation before they are placed on the UAE market. What changes is customs treatment and who can sell to whom onshore. Our pages on free zone company formation and mainland company structures compare the structures generally.
Selecting the activity
Trade licence activity descriptions vary by authority. Choose an activity that clearly covers trading in medical, surgical and laboratory equipment, and add related activities such as maintenance, installation or import and export where the business will do them. An activity that is too narrow can block a later registration; an activity that is too broad may trigger extra approvals.
The licensing process step by step
- Confirm the product scope. List the devices, their classification, the manufacturers and whether any emit radiation or connect to networks. This decides which regulators are involved and how long registration will take.
- Incorporate and obtain the trade licence. Reserve the name, choose the activities and obtain the commercial licence from the Department of Economy and Tourism or the free zone authority.
- Secure compliant premises. Lease a warehouse or store that can meet good storage and distribution standards, including temperature control where products require it. Do not fit out before checking the regulator's current requirements.
- Appoint qualified staff. Pharmaceutical establishments must be run by a qualified, licensed responsible person. Check the EDE's current requirements for the establishment type before recruiting.
- Apply for the EDE establishment licence. Submit the application with the trade licence, lease, layout, staff credentials and procedures, and prepare for inspection.
- Register the importer with customs. Obtain an importer code from Dubai Customs so the company can clear shipments in its own name.
- Obtain marketing authorisations. File each device with the EDE, usually supported by the manufacturer's quality certification, free sale evidence, declaration of conformity and technical documentation.
- Import, sell and monitor. Apply for import permits for each consignment, keep traceability records and run vigilance and recall procedures.
Timelines depend heavily on the device class and the completeness of the manufacturer's file. Higher-risk devices need more evidence and take longer. A realistic plan treats the first legal sale as months, not weeks, after incorporation.
Budgeting for a medical equipment trading licence Dubai launch
Government fees are only part of the cost. A realistic budget for a medical equipment trading licence Dubai launch also covers rent on compliant premises while applications are pending, salaries for the responsible person and technical staff before revenue starts, warehouse fit-out and monitoring equipment, legalisation and translation of manufacturer documents, registration fees for each device, insurance, and the cost of training customers and servicing installed equipment. Because devices cannot be sold until registered, working capital is usually the constraint. Sequence registrations so that the products with the clearest files and strongest demand are filed first, and agree with the manufacturer who pays for each filing and renewal.
Lenders and investors will ask for the same timeline. A business plan that assumes revenue from the first month, before marketing authorisations are granted, tends to be rejected or, worse, funded on a basis that later causes a cash crisis. Model a conservative case in which the slowest registrations take longer than expected.
Device registration and documents
For most applicants, device registration is the longest part of the medical equipment trading licence Dubai process. Registration is product by product. The marketing authorisation holder is responsible for the file, and the relationship between the foreign manufacturer and the UAE company should be settled before filing. Typical evidence includes:
- a letter of authorisation from the manufacturer appointing the UAE company;
- quality management certification for the manufacturer;
- evidence that the device is approved or freely sold in a reference market;
- a declaration of conformity and technical documentation, including labelling and instructions for use;
- clinical or performance evidence proportionate to the risk class; and
- legalised or attested documents where the regulator requires them.
Who holds the registration is a commercial question. If the distributor registers devices in its own name and the relationship ends, the manufacturer may be unable to supply the market until the file is transferred. Our page on pharmaceutical registration and distribution discusses the same issue for medicines.
Negotiate file ownership before you file. The distribution agreement should state who holds each marketing authorisation, who pays for it, and how it is transferred or cancelled when the agreement ends. Without that clause, a manufacturer can find its own products locked in a former distributor's name.
Distribution and agency agreements
Most medical equipment traders act for foreign manufacturers. The contract shapes everything from exclusivity to recall costs, so it deserves as much attention as the licence.
- Agency or distribution. A registered commercial agency gives the agent statutory protection under the commercial agencies law, while an unregistered distribution agreement is governed mainly by its own terms. See our pages on commercial agencies and distribution and agency agreements.
- Territory and channels. Define whether the UAE company covers all emirates, free zones, public tenders and other GCC states, and whether the manufacturer can sell directly to key accounts.
- Regulatory responsibilities. Allocate registration, vigilance reporting, field safety notices, recalls, storage standards and training between the parties.
- Service and spare parts. Hospitals expect installation, calibration and maintenance. The contract should secure parts, training and technical support for the life of installed equipment.
- Exit. Cover termination notice, buy-back of stock, transfer of registrations and continuity of service for existing customers.
Post-market obligations
A medical equipment trading licence Dubai companies hold is only as secure as their compliance after launch. The 2024 law strengthened post-market duties and penalties, which can include fines, suspension and withdrawal of products.
- Vigilance. Adverse events and incidents involving devices must be monitored and reported to the EDE, and manufacturers' field safety notices must reach the right customers.
- Recalls and traceability. Keep records that link batch or serial numbers to customers, so that a recall can be executed quickly.
- Changes to registered devices. Significant changes to a device, its labelling or its manufacturer need regulatory approval or notification before the changed product is supplied.
- Advertising. Promotion of medical products needs regulatory approval and must stay within the approved claims. Our guide to healthcare advertising rules explains the limits.
- Renewals. Marketing authorisations and establishment licences have fixed terms. Track renewal dates centrally.
Tax points
Tax registration is not part of the medical equipment trading licence Dubai process itself, but it follows quickly once trading starts. VAT on medical products depends on Cabinet decisions listing zero-rated items. Cabinet Decision No. 149 of 2026 merged the separate medicine and medical equipment categories in the VAT Executive Regulation into one category of medical products, with most amendments in force from 1 October 2026, so traders should check each product against the current list on the Federal Tax Authority's legislation page. Corporate tax applies to trading profits in the normal way, and free zone companies should not assume that onshore sales qualify for the 0% rate.
An illustrative scenario
Illustrative only; the parties are generic. A European manufacturer of patient monitors wants to enter the UAE. A local entrepreneur offers to act as distributor and proposes to register the monitors in the distributor's own company name to save time.
Before signing, the manufacturer asks three questions. Can the distributor's company actually hold the establishment licence and meet storage standards? Who will own the marketing authorisations? And what happens to installed monitors if the relationship ends? The resulting agreement makes the distributor responsible for the establishment licence, customs and vigilance reporting, keeps the manufacturer's control over transfer of the registrations, sets performance targets for exclusivity, and requires the distributor to maintain spare parts and service for installed equipment for an agreed period after termination.
The distributor sets up on the mainland because its main customers are private hospitals and public tenders, and uses a logistics free zone warehouse for regional re-exports.
Risks and common mistakes
Assuming the trade licence is enough
A trade licence listing medical equipment trading does not authorise the company to import or sell regulated devices. Without the EDE establishment licence and a marketing authorisation for each device, shipments can be held at the port and sales are unlawful. Build the regulatory timeline into the business plan before committing to stock, staff and premises, and plan cash flow for several months without revenue.
Leasing premises before checking storage standards
Warehouses for medical products must meet storage and distribution standards, including temperature and humidity control where products require it, segregation of quarantined goods and proper documentation. Premises leased without checking these requirements may need costly modification or may not be licensable at all. Review the regulator's current requirements and, if possible, have the layout reviewed before signing the lease.
Giving away control of registrations
Manufacturers sometimes let a distributor register devices in its own name. If the relationship later breaks down, the manufacturer may be unable to appoint a new distributor until the registration is transferred, and the former distributor holds leverage. Agree in writing who holds each registration, how it is transferred and what happens on termination. Where a commercial agency is registered, take advice on the statutory protections that follow.
Forgetting radiation and connectivity approvals
Imaging equipment and other devices that emit ionising radiation need FANR licensing in addition to EDE approval. Devices with radio or network connectivity may need telecoms type approval. Devices that store or transmit patient data raise health data obligations for the facilities that use them. Identify these layers early, because they can add significant time to the launch plan.
What to do next
Before you apply for a medical equipment trading licence Dubai authorities will issue, confirm your product list and its classification, choose the route that matches your customers, check premises against storage standards, and settle the manufacturer agreement, including registration ownership. Then run the commercial and regulatory applications in parallel where the rules allow.
TRW & Co advises manufacturers, distributors and investors on market entry, distribution and agency agreements, regulatory strategy and disputes. Our healthcare regulation practice works with regulatory consultants on filings where needed. To discuss your plans, contact our Dubai team at info@trw.co or +971 58 942 1012.
Frequently asked questions
01Who issues a medical equipment trading licence in Dubai?
Two layers of authority are involved. The commercial licence comes from the Dubai Department of Economy and Tourism for a mainland company, or from the relevant free zone authority. The regulatory approvals come from the Emirates Drug Establishment, which licenses pharmaceutical establishments such as medical stores and warehouses and grants marketing authorisations for each device. Other regulators may be involved for specific equipment, such as FANR for devices that emit radiation. All the layers must be in place before devices are imported or sold.
02Do I need to register every medical device separately?
In general, yes. Each medical device needs marketing authorisation from the Emirates Drug Establishment before it is imported, manufactured or sold for circulation in the UAE. The evidence required increases with the risk class of the device. Changes to registered devices, their labelling or manufacturer may need approval or notification. Plan registrations product by product and agree with the manufacturer which company holds each authorisation.
03Can a free zone company sell medical equipment to Dubai hospitals?
A free zone company still needs the EDE establishment licence and device marketing authorisations, so the regulatory work is the same. The difference is commercial and customs-related: many free zone companies cannot sell directly onshore and instead supply through a mainland distributor, or hold a mainland licence as well. Dubai Healthcare City has its own regime. Check the specific zone's rules and the customs treatment before choosing a structure.
04Can a foreigner own 100% of a medical equipment trading company in Dubai?
Generally yes. Since the Commercial Companies Law was liberalised, foreign investors can own mainland companies outright for most trading activities, subject to the activity list and any specific conditions. Free zone companies have long allowed full foreign ownership. Ownership does not remove the regulatory requirements: the company must still hold the EDE establishment licence, employ qualified staff and register its devices.
05How long does it take to start trading medical equipment in Dubai?
The trade licence can often be obtained quickly, but the regulatory steps take longer. The EDE establishment licence depends on compliant premises, qualified staff and inspection, and each device registration depends on the class of device and the quality of the manufacturer's documentation. Higher-risk devices take longer. Most new entrants should plan for several months between incorporation and the first lawful sale, and budget accordingly.
06Is VAT charged on medical equipment in the UAE?
Some medical equipment is zero-rated, but only items within the Cabinet decision listing zero-rated medical products. Other items are taxed at the standard 5% rate. Cabinet Decision No. 149 of 2026 merged the medicine and medical equipment categories in the VAT Executive Regulation into a single medical products category, with most amendments in force from 1 October 2026. Traders should check each product line against the current list rather than assume all their products qualify.
Sources and official materials
- Emirates Drug Establishment — Federal regulator for medical products, devices and pharmaceutical establishments
- Federal Decree-Law No. 38 of 2024 on medical products, the pharmacy profession and pharmaceutical establishments — Marketing approval, establishment licensing and vigilance
- Dubai Healthcare City — Healthcare free zone and its licensing regime
- Dubai Customs — Importer registration and clearance of regulated goods
- Federal Authority for Nuclear Regulation — Licensing of radiation-emitting equipment
- Dubai Health Authority — Licensing of health facilities and professionals in Dubai
- Federal Tax Authority: Legislation — VAT Executive Regulation and zero-rating of medical products
General information only, current as at 27 October 2026. It is not legal advice and does not create a lawyer–client relationship. UAE law differs between the onshore jurisdiction, the DIFC, ADGM and the free zones, and changes frequently; check current official sources and take advice on the facts of your matter.
