The Pharma and Medical Equipment industry is one of the fastest-growing sectors in Dubai. UAE has about 18 Multinational Companies in the Medical Devices business.
The regional distribution network for Medical Devices and Pharma is very robust and extensive in Dubai.
Export of Medical Devices from Dubai
The top destinations of Medical Device exports from Dubai are to the USA (26%) and KSA (23%).
Major export items are laboratory machines, medical equipment, instruments and appliances for medical, surgical, dental use, & medical furniture
The Growing Healthcare Sector in the UAE
The Healthcare sector in the UAE is very mature and robust. The network of Hospitals and Health Centers are growing significantly to cater to various patient requirements.
A rise in Demand for Medical Devices and Equipment
Considering the current situation of the global pandemic, the importation and buying of the medical device have become significantly a mainstream requirement for healthcare clinics and hospitals.
It has become a need of the hour to meet the rising demand for various equipment such as testing kits, PPE suits, ventilators, and more medical devices.
Import of Medical Devices in the UAE
To import Medical Devices, Medical Equipment, and related medical consumables into UAE, there are certain requirements.
Ministry of Health governs the distribution and import of Medical Devices and Equipment in UAE.
There are strict regulations in place regarding the import and distribution of medical items in the UAE. Any default in the licensing procedures will be incurring huge fines and legal actions.
Steps Involved in the Import of Medical Devices in the UAE
1. Forming an LLC Company with DED
To initiate the import and distribution of medical devices in the UAE, register an LLC Company with the Department of Economic Development (DED).
Select the right activity list related to the nature of the business. while registering the company, it is a crucial step.
The company has to register with the Customs to get the import/export code for shipping in the medical devices into the UAE.
2. Registering the Medical Product with the Ministry of Health
Also, the company’s medical product has to be registered with the Ministry of Health. Concerned Health Authorities must approve the right business activities, medical products before selling them in the UAE
Obtain all legal documentation and clearances prior to conducting trade in the UAE to avoid penalties and legal actions.
3. Working with a Local Distribution Agent
Alternatively, the company can engage a local distribution agent or commercial agent.
The local distributor/agents are registered with the Ministry of Health for carrying out imports and distribution of medical products in the UAE.
On behalf of the company, the agent will then register the medical products with the Ministry of health.
The commercial agency/local agent will be owning the distribution rights of the product in the UAE.
Activities Listed in the Dubai DED under Medical Devices Trading & Importing
Following activities are listed in the Dubai DED related to the Trading and Importing of Medical Equipment, Instruments, and Devices:
1. Medical, Surgical Articles & Requisites Trading
Instruments & precise medical apparatuses used for the treatment of specific diseases can be imported under the activity license
- Earphones for hearing aids
- Batteries for cardiac patients
- Pulse regulators
- Walking sticks
- Splints for bone fractures
- Medical shoes
- and many more.
To know more about the specific activities listed, reach out to our expert Business Consultants. We will share with you the complete activity list and scope of company formation in the UAE.
2. Medical, Surgical Equipment & Instruments Trading
Imports and reselling of instruments and equipment used in hospitals and clinics for the following medical use are grouped under the specific business activity.
- Surgical Operations
- Blood Preservation
- And many more
Medical Device Trading Company Setup in UAE
LLC Company Formation for Medical Devices Trading Activities & Imports to UAE
To cover more medical devices, equipment trading activities under the same Trade License, applying for an LLC Company is a preferable option.
Both the trading of medical equipment and the import of equipment can be included in the same license while forming an LLC Company.
Corporate Sponsors for LLC Company Formation in UAE
Corporate partners are also a popular way of assigning local sponsors in the mainland company setup.
The corporate sponsor will come handy if the investment is for a long term and foreign investor wants to own total control of the management and operations.
Product Registration with the Ministry of Health and Prevention (MOHAP)
The product has to be submitted to the authority for inspection, testing, and issuing the certificate of classification. It makes the product eligible to import and sell in the UAE.
It will approximately take 30-45 days to complete the test and issue the certificate to import and sell.
Company Registration with the Ministry of Health and Prevention (MOHAP)
As the product is registered with the authority and classified, the importer has two options to initiate the trade.
Option -1 Direct Selling
Take a minimum warehouse space and register as an authorized reseller of the devices from the Dubai Economy (form an LLC Company in Mainland of UAE).
Warehouses with International Standard for storing Medical Devices Safely
The warehouse has to be equipped to store the medical devices safely and has to be meet international standards. It will enable you to directly sell to hospitals or any health facility.
The health facility or hospital has to have a qualified employee to operate the medical devices.
Option -2 Using an Intermediate Registered Agent
If a company is using a third-party registered agent there is no requirement of any warehouse space. The registered agent will act as the authorized reseller and distribute the medical devices on behalf of your company.
Documents Required to Start a Medical Device Manufacturing or Distribution Business in Dubai, UAE
- Application form from the Department of Economic Development (DED) to register the business
- Notarized and authorized letter to be submitted to the Ministry of Health for getting the required clearance for the imports of medical devices.
- ISO 13485 certification issued for the manufacturing unit of medical devices in the country of origin.
- Company profile in detail
- List of products manufactured and imported to the UAE
- Manufacturing license of the company in the country of origin.
To know more about the process of importing and selling Medical Devices in the UAE, talk to our experts!
Contact: Aurion Business Consultants