An Introduction to the United Arab Emirates
The United Arab Emirates (UAE) is a federation of seven emirates – Abu Dhabi, Ajman, Dubai, Fujairah, Ras al-Khaimah, Sharjah and Umm al-Quwain. Located in the eastern part of the Arabian Peninsula, it extends along part of the Gulf of Oman and the southern coast of the Persian Gulf. Neighboring the nation are Saudi Arabia to the west and south, Oman to the east and Qatar to the north.
Of all the emirates that make up the UAE, Abu Dhabi accounts for 87% of the UAE’s total area, while Ajman, the smallest emirate, accounts for less than 1% of the UAE’s total area. The UAE’s total population is 9.6 million, and with about 36% of that in Dubai, it makes it the most populated emirate while Abu Dhabi is the second most populated emirate.
UAE Healthcare Market at a Glance
The UAE healthcare market is expected to experience tremendous growth over the coming years, according to a report by the US-UAE Business Council. In June 2015, RNCOS, a global business consultancy, predicted that the market would grow at a compound annual rate of 7% between 2015 and 2020, but in February 2016, regional investment company Alpen Capital forecasted an annual average growth rate of 12.7% between 2015 and 2020 and estimated that the total UAE healthcare market would reach $19.5 billion by 2020.
Public Sector Healthcare
In the UAE, there is a public healthcare system for Emiratis. Primary healthcare centers provide primary care while hospital care is delivered through general and central specialized hospitals. Abu Dhabi Health Services Company (SEHA), Dubai Health Authority (DHA) and the Ministry of Health and Prevention (MOHAP) are the three public sector institutions that play a major role in the nation’s healthcare provision.
Owned by the government of Abu Dhabi, SEHA is an independent, public joint stock company that manages and develops the public hospitals and clinics of the emirate. The SEHA health system, the largest healthcare network in the UAE, is made up of 12 hospitals, 46 primary healthcare clinics, 10 disease prevention and screening centers, three mobile clinics, one school clinic, two blood banks, four dental centers, two employee healthcare centers and one vaccination center. It’s flagship business entities include the Al Mafraq Hospital, the Al Ain Hospital and the Tawam Hospital.
The Dubai Health Authority’s aim is to provide an accessible, effective and integrated healthcare system, protect public health and improve the quality of life within Dubai. Its mission is to ensure access to health services, maintain and improve the quality of these services, improve the health status of nationals, residents and visitors and oversee a dynamic, efficient and innovative health sector. As well as overseeing Dubai’s health sector, the DHA focuses on providing services through DHA healthcare facilities including hospitals, specialty centers and DHA primary health centers.
The Ministry of Health and Prevention’s mission is to enhance community health by providing comprehensive, innovative and fair healthcare services as per international standards as well as perform its role as a regulator and a supervisor of the healthcare sector through a modern and integrated health legislative system. According to the US-UAE Business Council’s September 2016 report on the UAE healthcare sector, as of June 2014, the then-Ministry of Health oversaw 16 hospitals and 67 clinics across the country.
Private Sector Healthcare
Delivered through clinics, private hospitals and medical cities, the private healthcare services sector is growing rapidly all over the UAE. Private healthcare sector growth has been driven by the needs of large numbers of foreign workers and expatriates who are not eligible to use MOHAP facilities except for in the case of emergencies. Major players in the UAE’s private healthcare sector include NMC Healthcare, Mediclinic Middle East and VPS Healthcare.
NMC Healthcare, the UAE’s largest private healthcare provider, has two main branches of business: NMC Healthcare and NMC Trading. The NMC group currently operates or manages eight hospitals, two day-care patient centers, nine medical centers and 15 pharmacies. It also owns and operates Clinica Eugin, a fertility treatment center in Barcelona, Spain, and owns a 51% shareholding in Fakih IVF Group. Moreover, NMC owns and operates Americare Group, a home care provider in the UAE as well as ProVita, a provider of long-term medical care in the UAE. The group is also a UAE supplier of products and consumables across several key market segments, with the major contribution coming from healthcare-related products.
Mediclinic Middle East is part of Mediclinic International, a private hospital group with three operating platforms in Southern Africa, Switzerland and the UAE, as well as a 29.9% shareholding in Spire Healthcare, a UK-based healthcare group. In February 2016, Mediclinic International combined with Al Noor Hospitals Group, with operations mainly in Abu Dhabi, to create an enlarged Mediclinic group which now boasts 73 hospitals and 43 clinics. Mediclinic Middle East operates six hospitals and over 30 clinics in the UAE.
It is VPS Healthcare’s mission to achieve world-class corporate governance in healthcare, using technology and the latest medical advances to provide services and outcomes that exceed expectations. VPS Healthcare caters for patients from all tiers of society through its healthcare facilities viz. Burjeel hospitals in Abu Dhabi and Dubai, Burjeel clinics, two LLH Hospitals in Abu Dhabi and three Oman-based Lifeline hospitals.
UAE’s Medical Devices Market
All medical devices must be approved by the MOHAP’s Drug Registration and Control Department. They must undergo a classification decision, which will determine if the MOHAP requires full registration or not.
If registration is not required, a waiver letter will be issued, declaring a free importation or importation with certain conditions. Imported medical devices will not be cleared by Customs unless the MOHAP has issued a pre-approval for importation of the consignment. If the exporter company/manufacturer has no legal presence in the UAE., it must appoint a local representative to act on its behalf to register the products. The local representative should be licensed by the MOHAP and must be appointed by written contract stating the appointment of the local authorized representative by the company.
An application to register a medical device must be made by the device manufacturer or its local representative/distributor. The local representative/distributer must be formally authorized by the manufacturer to manage the application process and the manufacturer’s legal obligations and responsibilities related to introducing the product in the UAE market. It is a requirement for the authorized representative/distributer to be available to interact between the medical device manufacturer and the MOHAP.
Medical device regulations are currently based on EU, Australian TGA and US Food and Drug Administration regulations. Products with EU, Australian, Canadian and US approval are eligible for a shortened registration process, and once the exporter company/manufacturer or distributor has been approved by the MOHAP committee, a registration number that is valid for five years will be issued. The application approval issuance depends on the completion of the required documents by the MOHAP.