Healthcare is a vital sector in every part of the world. It is a significant contributor to the economy and overall development of a nation, and in this race, the medical industry of Dubai is not behind. There is a very robust and mature healthcare sector here. The government is actively working to improve its healthcare services and to increase them.
It is establishing world-class hospitals, installing state-of-art medical equipment, laboratories and using the latest technology to cater to the needs of its users, which is why there is an enormous opportunity for setting up a medical laboratory company in the UAE and specifically in Dubai because many laboratories and medical clinics are being established in this area.
The UAE Ministry of Health and Prevention maintains a list of all pharmaceutical goods and medical laboratories. Federal law specifies that only licensed drugs, supplies, and other prescription products can be sold throughout the country. Consequently, only licensed goods can get permission to import. Any business that wants to establish a medical laboratory must also register itself with the UAE Ministry of Health and Prevention and the equipment that it intends to sell.
Why is there a Rise in Demand for Medical Devices and Laboratory in Dubai?
Considering the current COVID-19 situation, the global pandemic, the importation, and procurement of the medical device have become substantially an everyday necessity for health clinics, laboratories, and hospitals. To meet the rising demand for multiple laboratories for testing different samples, blood, PPE suits, ventilators, and more medical equipment, it has become an hourly requirement.
License Required to Set Up a Medical Laboratory in Dubai
You'll need a business license to set up any business in Dubai. You need to apply for a license agreement with the Department of Economic Development (DED) to set up your medical laboratory. And you can only register your business as a Limited Liability Company ( LLC) if you are a foreign national. For setting up an LLC in Dubai, it is mandatory to partner with a local sponsor who will be a 51% shareholder in the company while the remaining 49% will be owned by the non-UAE national partner / s.
List of Activities Permitted for Importing Medical Equipment under DED
The following are the tasks listed for trading and importing Medical Equipment, Devices and Tools under DED Dubai.
Medical, Surgical Articles and Requisites Trading
Tools & precise medical devices used to treat specific diseases can be purchased 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 Instrument Trading
Imports and resale of the equipment and materials used in hospitals and clinics for subsequent medical use are listed under separate business activities.
- Surgical Surgery
- Blood Preservation
- Sterilization, and many more
Steps Involved in the Import of Medical Laboratory in Dubai
The UAE government provides numerous opportunities to raise the country's healthcare quality to develop the sector and liberalize its import policies. The country's total medical cost is projected to be 4.6 percent of its GDP by 2026. It is the right time to set up if you want to start a medical equipment import or distribution company. Let us look at the documents required and the process to follow to start a medical laboratory business in Dubai.
Step 1 - Start an LLC Company in Dubai Mainland
To start your medical device import and distribution operations in Dubai, you have to register with the DED as an LLC Firm. You must pick the correct business operation for this application, relevant to the nature of the company. Then, register with the customs to get the import/export code for shipping into the country in the medical devices.
Stage 2: Register medical goods with the health ministry
Medical products from the company have to be licensed with the Dubai Ministry of Health. The health authorities concerned must authorize the correct business practices, pharmaceutical products, before selling them at the UAE. Obtain all legal paperwork and clearances to escape restrictions and enforcement proceedings before conducting trade in the UAE.
Step 3: Collaborating with a Nearby Dealer
The business, on the other hand, may hire a local distribution agent or a commercial agent. Local distributors/agents are registered with the Ministry of Health to import and to sell medical products in Dubai, UAE. The agent must then register the medical products with the Ministry of Health, on behalf of the company. The sales agency / local agent will own the product's licensing rights in the UAE.
Documents needed to complete the enrollment process
- MOHAP gives warehouse license
- Pharmacist's license in charge of the warehouse
- Legal warehouse exchange license
- Certificate of Minimal Product Variability, if any
- Data, catalog, and photographs of each product according to the invoice
- Guarantee of product registration, if any;
- Free-sales certificate issued by the country of origin
- Guarantee of Good Quality (GMP)
- Purchase invoice including country of origin and the production and expiry dates
- Certificate of Product Quality (C.E. – ISO-Certificate of FDA)
These procedures might seem a little tough for you. That is where we come into the picture. Our business setup consultants in Dubai are so well-versed with the legalities of setting up a medical laboratory and can assist you from start to finish.
Commitbiz Consultants acts as a leading consultant dedicated to providing dedicated customers with the best enterprise incorporation services. Our business professionals take every care to provide the best services that suit their business needs.
At Commitbiz, we help many firms established in Dubai and the UAE and can provide invaluable guidance and expertise in navigating the business environment. For support and guidance in setting up a medical laboratory in Dubai, or to grow a global business
Contact us today – we’d be glad to help you.
What is the renewal fee for a DHA license?
6000 AED is the renewal fee of the DHA license.
Will my medical laboratory in Dubai be verified before opening?
Yes, DHA verifies the blueprint of your laboratory and a final inspection after execution will also be done
What is the cost of setting up a medical laboratory in Dubai?
It depends on the speciality you choose, the location and the scale of your set-up.
Can an individual apply for a laboratory license in Dubai?
Yes, you will need approvals from DDA.
Dubai medical laboratory license will be issued by?
Department of Economic Development of Dubai issues the license.