For importing medical equipment, devices and other consumables into the UAE spanning both Dubai and Abu Dhabi, there are specific regulations in place. The import and distribution of medical devices is controlled by the Ministry of Health in the UAE. The company importing these devices/equipment should be registered with the Ministry with suitable activities listed on the Trade License from DED (Department of Economic Development). The importer is required to be a legal entity with an establishment in the country or at least a UAE national.
Medical equipment should be registered individually with the Ministry of Health and companies should thus set up a legal entity in the country while applying for registration of the company with the Ministry thereafter. Alternatively, they may engage with local commercial/distribution agents with registration (previously done with the Ministry of Health) for distribution and importation of medical devices/products. The agent will be individually registering products for them in the UAE. The local agent may also own the distribution rights in the country for the company in question.
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Major guidelines and information for Import and Sell Medical Devices in the UAE
There are two activities listed down in the DED guidelines linked to importing and trading of medical equipment, instruments and devices. These include the following:
- Surgical, Medical Articles and Requisite Trading- This covers reselling for specific medical instruments and apparatuses for treating various ailments including batteries for cardiac patients, earphones, pulse regulators, splints for fractures, walking-sticks, artificial limbs, medical shoes and surgical equipment like parts for damaged organ replacement, artificial organs, heart valves, bone joints and suture bandages or plasters.
- Surgical and Medical Equipment along with Instruments Trading- This covers reselling equipment and instruments used across clinics and hospitals for treatment, surgical activity, medicine, diagnosis, blood preservation, waste disposal, X-raying, physical therapy, sterilization and rehabilitation. It also covers manual kits, instruments used for medical check-ups, bandaging, surgical operations and electronic devices with communication technologies.
A single license may be issued for covering both medical device trading operations via an LLC (limited liability company) only. 51% ownership should be under a local entity although activities may be permitted with a 49% foreign party ownership and 51% corporate nominee partner ownership. Commercial agents are not needed for importing these goods and hence foreign parties can retain control safely over the long haul.
MOHAP Registration in UAE
Registration with MOHAP (Ministry of Health and Prevention) requires adherence to these factors:
- MOHAP will be issuing a classification certificate if the product adheres to regulations/rules for importing and selling in the UAE. Every product costs AED 500 for registration purposes. 10 working days may be needed for product registration.
- Product registration is needed for enabling product sale within the UAE. The cost is AED 5,100 (per product) for registration and application. This may require up to 45 working days.
- Companies should be registered as authorized resellers of medical devices.
- A minimum warehousing facility of 2,000 sq. ft. should be present while meeting fire safety requirements along with having air conditioning.
- Companies desiring to use intermediary registered sellers for hospitals/healthcare systems may not have warehouses or registration mandatorily.
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