Healthcare is an essential sector in every part of the globe. It is a significant contributor to a nation’s economy and its overall development, and the UAE’s medical sector is not behind in this race. The healthcare sector here is very robust and mature. The government is actively working towards improving and increasing its healthcare offerings. It is building world-class hospitals, installing state-of-art medical equipment, and using the latest technologies to cater to the needs of its users, which is why, there is an immense opportunity for starting a medical equipment trading company in the UAE and specifically in Dubai, since many hospitals and medical clinics are being set up in this city.
The UAE Ministry of Health and Prevention preserves a register of all medical equipment and pharmaceutical products. The federal law says that only registered medicines, equipment, and other pharmaceutical products can be distributed within the nation. Hence, only registered products will receive import permission. Any company that wants to trade in medical equipment must also register itself and the equipment it wishes to trade with the UAE Ministry of Health and Prevention.
Why is there a Rise in Demand for Medical Devices and Equipment in Dubai?
Considering the current situation of COVID-19, the global pandemic, the importation, and buying of the medical device have become a mainstream requirement for healthcare clinics and hospitals significantly. It has become a need of the hour to meet the rising demand for numerous equipment such as testing kits, PPE suits, ventilators, and more medical devices.
License Required to Set Up a Medical Equipment Company in Dubai
To set up any business in Dubai, you need a business license. For establishing your medical equipment business, you need to apply for a commercial license with the Department of Economic Development (DED). And if you are a foreign national, you can only register your business as a Limited Liability Company (LLC). To set up an LLC in Dubai, it is obligatory to partner with a local sponsor who will be a 51% shareholder in the company while the non-UAE national partner/s will hold the remaining 49%.
List of Activities Permitted for Importing Medical Equipment under DED
The following are the activities listed under the DED Dubai for trading and importing of Medical Equipment, devices, and instruments.
Medical, Surgical Articles and Requisites Trading
Instruments & precise medical apparatuses used for the treatment of specific diseases can be imported under the activity license. It includes -
- Earphones for hearing aids
- Batteries for cardiac patients
- Pulse regulators
- Walking sticks
- Splints for bone fractures
- Medical shoes and many more
Medical, Surgical Equipment and Instruments Trading
Imports and reselling of instruments and equipment used in hospitals and clinics for the following medical use are grouped under specific business activity.
- Surgical Operations
- Blood Preservation
- Sterilization and many more
What are the Steps Involved in the Import of Medical Equipment in the UAE?
To improve the healthcare standard of the country and boost the sector, the government of UAE is offering different incentives and also liberalizing its import policies for foreign investors. It is expected that by 2026 the overall medical expense of the country would be 4.6 percent of its GDP. Thus, if you are looking to start a medical equipment import or distribution business, this is the right time to start. Let us have a look at the documents required and the procedures to follow to start a medical equipment business in Dubai.
Step 1: Opening an LLC Company in Dubai Mainland
To start your operations of import and distribution of medical devices in Dubai, you must register as an LLC Company with the DED. For this registration, you must select the appropriate business activity related to the nature of the business. Then, register with the customs to get the import/export code for shipping in the medical devices into the country.
Step 2: Register the Medical Products with the Ministry of Health
The company’s medical products must be registered with the Ministry of Health in Dubai. Concerned Health Authorities must approve the right business activities, medical products before selling them in the UAE. Obtain all legal documentation and clearances before conducting trade in the UAE to avoid penalties and legal actions.
Step 3: Working with a Local Distribution Agent
On the other hand, 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 Dubai, 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 own the distribution rights of the product in the UAE.
Documents Required to Complete the Registration Process
- The license of the medical warehouse issued by MOHAP
- The license of the pharmacist in charge of the warehouse
- Valid trade license of the warehouse
- Product Minor Variation Certificate, if any
- Information, catalog, and pictures of each product as per the invoice
- Product Registration Certificate, if any
- Certificate of free sale issued by the country of origin
- Good Manufacturing Certificate (GMP)
- Purchase invoice and include the country of origin and dates of production and expiry
- Product Quality Certificate (C.E. – ISO – FDA Certificate)
The steps might seem a little complicated for you. That is where we come into the picture. Our business setup consultants in Dubai are well-versed with the legalities of setting up a medical equipment business and can assist you from start to finish. Contact us today – we’d be glad to help you.
1. Which authority maintains a register of all medical equipment and products in the Emirates?
The UAE Ministry of Health.
2. Do we need a local sponsor to set up a medical LLC company in Dubai?
3. Which license is required for a medical equipment company in Dubai?
4. Which authority provides the license for a Dubai medical devices and equipment business?
Department of Economic Development.
5. Do we require a ‘Goods Manufacturing Certificate’ for a medical product company in Dubai?