From a strategic location and a robust infrastructure to a supportive business ecosystem and a burgeoning demand for medical innovations, Dubai, UAE, stands as a beacon of opportunity for entrepreneurs in the healthcare industry. One of the most lucrative business ideas in Dubai, UAE is starting a medical device importing and exporting business.
In this article, we’ll go through the intricacies of establishing an import and export business of medical devices in Dubai, UAE.
Importing and Exporting Medical Devices in the UAE: the legalities
The import and export, as well as the distribution of Medical Devices in the UAE, is controlled by the Ministry of Health and Prevention.
Companies wishing to import and sell medical devices within the UAE must be established in the UAE and apply for registration of the devices and equipment with the Ministry of Health.
To import and sell Medical Devices and Equipment in the UAE, there are several requirements:
- the company importing the equipment must be registered with the Ministry of Health with the related activities on the Trade License.
- The importer must be a legal entity established in the UAE or a UAE national.
- The medical equipment must be individually registered with the UAE Ministry of Health.
Alternatively, the company can be engaged with a local distribution or commercial agent, already registered with the Ministry of Health, for the importation and distribution of medical products, who can register the medical products for them.
The DED guidelines list two key activities linked to the importing, exporting, and trading of medical equipment and devices. These include the following:
- Surgical, Medical Articles, and Requisite Trading:
This covers the resale of certain medical treatment instruments, 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 activity includes the reselling of equipment and instruments used in clinics and hospitals for treatment, surgical activity, medicine, diagnosis, blood preservation, waste disposal, X-raying, physical therapy, sterilization, and rehabilitation. This activity also includes covers manual kits, medical check-up instruments, bandaging, surgical operations, and electronic devices with communication technologies.
How to start your importing and exporting medical devices business in Dubai, UAE
- Obtain a commercial license
You will need to obtain a commercial license from the Department of Economic Development (DED) in the Emirate where you plan to operate, or get a free zone commercial license.
- Register with the UAE Ministry of Health and Prevention (MOHAP)
To import and sell medical devices in the UAE, you have to register with the MOHAP, which needs detailed information about your company and the medical devices you intend to import and sell.
- Get a device marketing authorization
You need to obtain medical device marketing authorization from the MOHAP to market your goods.
- Get the necessary certifications
The medical devices you want to import, export, and sell must meet specific regulatory requirements in the UAE, including having certain certifications such as CE or FDA clearance, which prove that these medical devices meet international safety and quality standards.
- Collaborate with a distributor
Work with a distributor with good experience in importing and selling medical devices in the UAE.
- Comply with regulations
To avoid legal complications, make sure to follow the specific regulations and standards for importing and selling medical devices in the UAE.
How SPC Free Zone can help you?
SPC Free Zone promotes entrepreneurship and offers simple and value-added business support services. Whether you need an e-commerce license in UAE, a general trading license, or a professional license, we have it all covered. Additionally, you can apply for a dual-licensing option that provides mainland and free zone on the same license and up to 20 visas. Furthermore, the on-site immigration services allow you to get your license in just 45 minutes, and your UAE residency in 5 working days. Do you want to know how to start your business of importing and exporting medical devices in Dubai, UAE? Contact our team!
