Healthcare is the booming sector all over the world. People in the UAE, one of the fastest growing economies, lead a busy lifestyle. According to a survey conducted by WHO, a third of the adults in UAE are obese, and one out of five people live with diabetes. Thus, providing top-class healthcare facilities is a major priority for Dubai government and, as a result, the sector has improved and expanded significantly during the past few years.
The UAE government is working towards attracting medical tourists coming to the UAE by providing world-class healthcare facilities and infrastructure. The country has a robust transportation and well-built logistics and is strategically located to be the centre of a transportation network that connects the people from the different nation. These factors, in addition to its innovation-driven approach towards the healthcare industry, make the country an attractive location for setting up a medical equipment business.
Supplies and Importation of Medical Equipment in UAE
The UAE government is offering incentives and liberalizing its policies to seek the attention of foreign investors in order to improve healthcare standards and boost the healthcare industry. The overall medical expenditure of the UAE is expected to account for 4.6 percent of a country’s GDP by 2026. Thus, this is the right time for anyone to start a pharmaceutical equipment distribution or importation business in Dubai. Here are the documents required and the procedure for incorporation of a medical equipment business in UAE.
Requirements to Start a Medical Equipment Manufacturing or Distribution Business in Dubai, UAE
- All the medical devices must be approved by the UAE Ministry of Health (MOH) Drug Registration and Control Department
- Filled application form, signed and stamped by an authorized person in the company
- Issuing notarized and authorized original letter to a local establishment, giving an authority to submit the registration files on their behalf to the Drug Department & Distribution Rights
- Valid ISO 13485 certificate issued by the corresponding authority in the country of origin for each site involved in the manufacturing process of medical devices (notarized and legalized)
- Detailed company profile
- Products list manufactured or assembled by the site
- Legal and valid manufacturing license issued by the competent authority in the country of origin
- Once the procedure is completed UAE, Ministry of Health provides a registration number with the 5-year validity
How to Get a Medical Equipment Importation Company Registration in UAE?
- No imported medical devices will clear the customs unless the pre-approval is issued by the UAE Ministry of Health
- One needs to get a medical warehouse license from the Ministry of Health
- The UAE Ministry of Health will inspect the warehouse prior issuing the license
- Once the location and warehouse have been inspected, the company must provide the relevant documents to the authority. The required documents are:
- Proof of the inspection
- Information relating to the medical and pharmaceutical devices that the company intends to import
- Once the documents have been reviewed, the authority has the right to accept or reject the proposal
- If the Ministry accepts the file, it is passed to a final committee at the Ministry of Health
- The final committee meets four times a year to review all the proposals, and the best one is given the import license
- If the application is rejected, the authority will provide the reason as to why. This permits the company to make the necessary adjustments and apply again for the same.
If you are planning to set up any medical equipment related entity, be it a pharmacy, a hospital or a clinic in UAE – great! The requirement of medical devices has been increasing day by day in UAE due to the increased healthcare facilities. The world-class standards and quality-driven healthcare infrastructure in Dubai is welcoming people from all over the globe. So, take a step forward to contact business consultants to get guidance in starting your business in UAE.
Commitbiz Management Consultants can familiarize you with the business environment of the UAE. We help our clients in company incorporation process, taxation, accounting, bookkeeping, intellectual property protection, and other value-added services. For any business help or guidance on how to start your medical business in Dubai or the rest of the UAE, feel free to contact us – it’d be our pleasure to assist and be a part of your incorporation journey.