Coronavirus, global pandemic, lock-down, Covid-19, quarantine!
What comes to most peoples’ minds when they hear these words is damage, worry and stress; however, for others it is opportunity, investment and profits. Moreover, this is an opportunity to have a positive impact on this uncontrollable-at-the-moment virus.
In this article we discuss how a foreign entrepreneur can take this opportunity to set up a medical equipment company in Dubai, not just to help deal with the global pandemic and at the same time, the healthcare industry in general.
Healthcare is the most essential sector in the world, and a significant contributor to every country’s economy and overall development. For that reason, the Healthcare business is growing all around the world.
Why Dubai?
The Healthcare sector in UAE has improved significantly in the past few years. It aims to provide high quality diagnostic and treatment facilities to the citizens. The government invests in top class facilities to help their citizens with their health. Based on a survey conducted by the WHO, one in three adults in UAE are obese, and one in five are diabetic, this is due to their hectic work and social life.
UAE’s government aim is not only to support their citizens, but also the medical tourists by providing them with excellent healthcare facilities. Countless of medical tourists are choosing Dubai which leads to a further increase on demand for high-quality medical equipment.
As the government is enthusiastically improving its healthcare sector by building world-class hospitals with the latest technologies to serve the needs of its users, there is an immense opportunity for entrepreneurs to set up their own medical equipment trading company in UAE. Dubai is the main market, as most medical clinics and hospitals are established in this city.
Another reason that makes Dubai an ideal location to open a healthcare business is its tax-free environment, along with its favourable company setup conditions and the populations' strong purchasing power.
Why you should start your Health Care Business now?
It is a great time to start a medical equipment company in Dubai right now because the government is offering different incentives as well as liberalizing its import policies for foreign investors.
Besides that, it is expected that by 2026 the overall medical expense of the country would be 4.6% of its GDP. Adding to this, spending on medical care is expected to top AED100 million by 2021. It has been noticed that most of the growth in UAE comes from a continuous increase in demand and interest on specialist and preventative care.
In light of the current global pandemic, there is a pressing need for necessary medical equipment to help and support medical professions in Dubai. This again makes it the best time for foreign investors and entrepreneurs to open a healthcare company in Dubai now.
Setting up a Medical Equipment Company in Dubai
Setting up your medical business in Dubai is relatively simple. A commercial license is needed for establishing a medical equipment business, with the Department of Economic Development (DED).
There are different kinds of businesses you could open, that includes a healthcare facility, a specialty practice, or a medical instrument importation. Even though these businesses are diverse and require different licensing, many of the steps explained next are the same.
A medical equipment trading company in Dubai is not only in high demand, but it can have a very profitable return for business owners!
Now it’s time to have a look at all the required documents and procedures you need to follow to import medical equipment into Dubai. There are different types of activities permitted for Importing Medical Equipment.
List of Activities for Importing Medical Equipment permitted under DED
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Drug Store
A facility licensed to import and store registered pharmaceuticals, medical supplies, and herbal medicines alternative medicine drugs and distributes the same on wholesale basis.
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Para Pharmaceutical Products Trading
Includes reselling para-pharmaceutical products not directly used for medication or treatment, including plasters, after-shave lotions, creams, anti-smoking products, face masks, tooth pastes, mouth wash and others sterilization products.
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Pharmacy
A specialized facility licensed to sell and prepare registered drugs, pharmaceuticals, medical supplies and dispense herbal and medical drugs against medical prescription, according to the laws and regulations issued by competent authority of UAE. It is supervised by a licensed pharmacist who works permanently in a pharmacy.
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Medical, Surgical Articles & Requisites Trading
Includes reselling of certain instruments and precise medical apparatuses for treating of certain diseases, such as earphones, batteries for cardiac patients, pulse regulators, walking-sticks, splints for bone fractures, medical shoes, artificial limbs, dentures and other medical instruments, also, surgical requisites like artificial organs and parts to replace damaged organs, bone joints, heart valves, in additional to surgical suture bandages and plasters.
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Medical, Surgical Equipment & Instruments Trading
Includes reselling instruments and equipment used in hospitals and clinics for diagnosis, treatment, surgical operations, medicine and blood preservation, X-raying, sterilization, waste disposal, physical therapy and rehabilitation, also, manual kits and instruments used for check-up, surgical operations and bandaging, as well as electronic devices using communication techniques.
Registering a Medical Equipment Company
Now that the activities are clearer, here are the steps involved in the import of medical equipment.
Step 1: Opening an LLC Company in Dubai Mainland
In order to start importing and distributing the medical equipment in Dubai, you must be registered as an LLC Company with DED. Before doing that, you should select the appropriate business activity related to the nature of the business. Then you will be able to register with the customs to get the import/export code for shipping 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. The concerned Health Authorities must approve the business activities and medical products before they can be sold in the UAE. You need to obtain all legal documentation and clearances before conducting trade in the UAE to avoid penalties and legal actions.
Once the product has been registered and classified, the importer has a choice of two options in order to initiate the trade:
Option 1 - Direct Selling:
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If you are wishing to import goods and sell them directly to the hospitals or any health facility you will need to be registered as an authorized reseller of the product. Therefore you will need to register with MOHAP and meet their guidelines which include taking a minimum warehouse space.
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The warehouse facility should be a minimum of 2,000 sqft, meet Fire Safety requirements and also have air conditioning to protect imported medical devices against the heat of storage.
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The warehouse needs to be well-equipped to store the medical devices safely and is required to meet international standards.
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The health facility or hospital has to have a qualified employee to operate the medical devices. As an example, an X-ray machine would require a qualified radiologist to be allowed to purchase/operate the device.
Option 2 - Using an Intermediate Registered Agent
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The company can engage a local distribution agent or commercial agent.
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If a company is using a third-party registered agent there is no requirement of any warehouse space.
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On behalf of the company, the agent will then register the medical products with the Ministry of health.
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The registered agent will act as the authorized reseller and distribute the medical devices on behalf of your company.
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The commercial agency/local agent will own the distribution rights of the product in the UAE.
Summary of documents required
Documents required to start a Medical Equipment Manufacturing or Distribution Business in Dubai, UAE
Before starting the company formation in Dubai, you should ensure that all the medical equipment that you are planning to deal with is approved by the UAE Ministry of Health (MOH) Drug Registration and Control Department. The documents to be submitted include:
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Duly filled application form for starting the business. This should be signed and stamped by an authorized person of the company
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Notarized and authorized letter to a local company. This letter should give authority to the company to submit the registration files on their behalf to the concerned department i.e. the Drug Department & Distribution Rights.
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ISO 13485 certificate. This should be issued by the concerned authority in the country of origin. A separate certificate should be issued for each site that is a part of the manufacturing process of medical devices. (notarized and legalized)
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Company profile in detail.
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A list of the products manufactured or assembled by the site
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Manufacturing license issued to the site by the concerned authority in the country of origin. This license should be legal and valid.
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Once all the documents are submitted, and they are found to be in order, the Ministry of Health, UAE will provide a registration number which is valid for five years.
Registration Process of a Medical Equipment Import Company in the UAE
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First, you need to obtain a medical warehouse license issued by the Ministry of Health
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Before issuing the license, the Ministry of Health will inspect the warehouse.
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Once the inspection is over, the company should provide the below documents to the authority. The documents include
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A proof that the inspection was carried out.
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Details of the medical and pharmaceutical devices which the company plans to import.
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The authority will review the document and will accept or reject it.
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If accepted by the Ministry, the file is passed to a final committee at the Ministry of Health for approval.
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After reviewing, the final committee will provide the import license to the best proposal. For this purpose, the committee meets four times a year.
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If the application is rejected by any chance, the authority will communicate the reason for rejection. The company can then make the necessary changes and resubmit the application.
Conclusion
With its easy registration and setup procedures, UAE is certainly the best destination for setting up a medical trading company. There is ample opportunity to set up a business in the UAE.
If you wish, we can assist you with the incorporation process. This way, you should open your business in Dubai at no time and be part of the massive growth in the healthcare sector in the Emirates!
Contact us directly if you are interested in importing and selling health care products in Dubai.