This is a best prospect industry sector for this country. Includes a market overview and trade data.
The creation of a world-class healthcare infrastructure is a top priority for the government of the United Arab Emirates (U.A.E.) and, as a result, the sector has advanced and expanded significantly during the past few years. The World Health Organization determined that a third of adults in the U.A.E. are obese, and one out of five people live with diabetes. As the incidences of lifestyle diseases increase, these populations, supported by relatively high levels of income, will demand greater quality of healthcare. The government’s focus is on developing a healthcare infrastructure to address this demand. Healthcare is regulated at both the federal and emirate levels. Federal-level legislation dates back to the 1970s and 1980s and there are pending legislative reform initiatives to facilitate the development of the healthcare industry.
Currently, bed occupancy in the U.A.E. is under capacity by an estimated 80 percent. Healthcare expenditure as percentage of GDP represented an estimated 3.9 percent in 2015, a value of AED 54.56 billion ($14.85 billion), equating to $1, 622 per capita. In 2016, the expectation is for health expenditure to increase by 6 percent in local currency terms, reaching AED57.81 billion ($15.75 billion). Overall healthcare spending is expected to account for 3.82 percent of the country’s GDP by 2020, down slightly from 3.90 percent in 2015.
In June 2015, the U.A.E. government launched a new health insurance program in Dubai to support nationals not covered under any other government funded health insurance scheme. This scheme is expected to benefit 130,000 by offering healthcare at 23 private hospitals and more than 500 medical clinics in and around Dubai. The Dubai Health Authority (DHA) announced in June 2016, that all Dubai residents should be covered by health insurance that will be tied to the renewal and issuance of their U.A.E. residence visas.
The U.A.E. government wants to boost the number of medical tourists coming to the U.A.E. by establishing Dubai as a center of healthcare excellence in the region. The country has a robust transportation and logistics infrastructure and is geographically well positioned to be the center of a transportation network that links the economies of India and China to Europe and the United States. These factors also make the country an attractive location for establishing a regional distribution center for medical devices. While the U.A.E. is a zero tax country, the government is expected to implement 5 percent value added tax (VAT) in 2018.
According to investment experts, some of the biggest U.A.E. opportunities are likely to be found in healthcare projects. For instance, “Unison”, a public-private partnership between GE Healthcare, the U.A.E. Ministry of Health (MOH) and Abu Dhabi International Medical Services (ADI) aims to bring together the best of healthcare technology, hospital management, and patient care into one group of eleven radiology departments spread across the U.A.E. These types of partnerships are emblematic of the government’s efforts to privatize the public healthcare sector in the country.
As a general rule, a foreign company intending to conduct business in the U.A.E. must do so either by:
- Incorporating a local entity “Onshore”
- Incorporating an entity in one of the UAE’s many free zones
- Establishing a branch of representative office (either “onshore” within the UAE, or in one of the free zones
- Establishing a Local commercial agent
- Restrictions on foreign ownership limit foreign companies’ participation to a maximum of 49 percent of the equity in a U.A.E. “onshore” company.
- While an entity within one of the UAE’s free zones can be wholly owned by a foreign company.
Definition: any product, including accessories, used in healthcare for diagnosis, prevention, monitoring or treatment of illness or handicap excluding drugs. Medical devices can be consumables, diagnostic imaging, dental products, orthopedic & prosthetic products, and patient aids.
All medical devices must be approved by the U.A.E. MOH Drug Registration and Control Department. Imported medical devices will not be cleared by Customs unless a pre-approval for importation of the consignment is issued by MOH.
If the exporter company/manufacturer has no legal presence in the U.A.E., it will have to appoint a local representative to act on its behalf to register the devices. The local representative must be appointed by written contract stating the appointment of the local authorized representative by the company. The local representative should be licensed by the MOH.
Qualification of Registration of Medical Devices
An application to register a medical device in the U.A.E. must be made by the device manufacturer or its local representative/distributor. The local representative/distributer must be formally authorized by the manufacturer to handle the application process and the manufacturer’s legal obligations and responsibilities with regard to placing the medical device in the U.A.E. market. The authorized representative/distributer must be available to interact between the medical device manufacturer and the MOH.
Supporting Documents Required by the Medical Devices Committee
The applicant (exporter company/manufacturer or distributor) must provide the committee with the following documents:
- The application form duly filled, signed and stamped by the responsible person in the company
- Notarized letter issued by the company on its original letterhead, signed and stamped by the responsible person in the company, authorizing a person or a local establishment to submit the registration files on their behalf to the Drug Department & Distribution Rights
- Notarized Valid ISO13485 certificate issued by the competent authority in country of origin for each site involved in the manufacturing process
- Legal and valid business licenses ( manufacturing license issued by the competent authority in country of origin and attested true by the U.A.E. Embassy in Washington, DC) for legal manufacturer, final releaser & assembling site, if the site different than legal manufacturer
- List of the products manufactured and/or assembled by the site
- Detailed company profile
Medical Device Registration Process
Current U.A.E. medical device regulations are based upon EU, Australian TGA and U.S. (FDA) regulations. Products with EU, Australian, Canadian, and U.S. approval are eligible for a shortened registration process in the U.A.E. Furthermore, once the exporter company/manufacturer or distributor has been approved by MOH committee, a registration number will be given that is valid for five years. The application approval issuance depends on the completion of the required documents by MOH.
- Registration: The U.A.E. Commercial Companies Law requires that each company established in the U.A.E. have one or more U.A.E. national partner(s) who hold at least 51 percent of the company’s capital. Foreign companies may engage in a commercial agency arrangement whereby a foreign company is represented by a U.A.E. agent to distribute, sell, offer, or provide goods or services within the U.A.E. The agent must either be a person holding U.A.E. nationality or a company that is 100 percent owned by U.A.E. nationals.
- Customer Price Sensitivity: Most patients who travel to the U.A.E. for healthcare are from the Middle East and North Africa, Jordan, Thailand and India – all of which are cheaper healthcare destinations than the U.A.E. The U.A.E. maintains an advantage over these competitor nations vis-à-vis middle-to-high income patients. The U.A.E. must attract patients from the wealthy upper tier of Africa, the Middle East and Asia, which is not easy as many of them can afford to go to Europe for treatment. Where U.A.E. will be able to outperform European providers is in offering culturally-suitable care for Muslim patients and high quality specialized services.
In 2016, the major players in the private healthcare market in the U.A.E. are Al-Noor Medical Company, Al-Zahra Group, Belhoul Lifecare, Emirates Healthcare, Gulf Healthcare International, Gulf Medical Projects Company, Zulekha Hospital, Saudi German Hospital Group, GE Healthcare and Aster DM Healthcare.
Sub-Sector Best Prospects
The medical device market will register a 2015-2020 Compound Annual Growth Rate (CAGR) of 8.2 percent in U.S. dollar terms, down from a 2010-2015 CAGR of 11.2 percent, which will make the value AED5.3 billion ($1.4b billion). Slower growth is due lower oil prices, which will also slow medical device consumption over the forecast period. From a healthcare perspective, the U.A.E. is relatively well provided for in terms of hospitals and hospital beds, although it does suffer from a shortage of trained medical personnel. There are numerous hospital construction and renovation programs underway as a result of public and private investment. A growing medical tourism sector is generating demand for modern facilities with state-of the-art medical equipment. Medical device production will continue to be low, and only limited to basic items such as various types of syringes, and IV sets.
- The U.A.E. relies heavily on importing medical devices versus local production. Between 2005 and 2015 imports have increased by double digits.
- Dubai lunched a 3D printing strategy for medical devices to position that emirate as the manufacturing hub for 3D printing of medical devices by 2030. It will need internal and external investment to realize this goal.
- Use of mobile medical devices is growing in the U.A.E. There is demand for innovative technology to facilitate remote treatment of patients and medical device e-commerce. For example, AlMazroui Medical Group and Chemical Supplies started the first online store for medical equipment and supplies in U.A.E., called “Hejama,” in 2016.
Trade Shows & Exhibitions:
|Arab Health||30th of Jan – 2nd of Feb 2017||www.arabhealthonline.com|
|MED LAB||6th – 9th of Feb 2017||www.medlabme.com|
|OBS – GYNE||2nd – 7th of Apr 2017||www.obs-gyne.com|
|Hospital build||June 2017||http://buildinghealthcare-exhibition.com/|
- U.A.E.-Ministry of Trade: www.moft.gov.ae
- Ministry of Health: www.moh.gov.ae
- Health Authority Abu Dhabi: www.haad.ae
- Dubai Health Authority: www.dha.gov.ae
- Business Monitor International – Q3 2016
- Gulf News: http://gulfnews.com/news/uae/health/dubai-health-authority-to-fully-implement-mandatory-health-insurance-by-june-1.1713672
U.A.E. Government Health Care Links:
- Dubai Health Authority: www.dha.gov.ae
- Dubai Ministry of Health: www.moh.gov.ae
- Dubai Healthcare City (Free Zone): www.dhcc.ae
- Abu Dhabi Health Authority: www.haad.ae
- Abu Dhabi Health Service Company: www.SEHA.gov.ae
- Sharjah Heath Care City: www.shcc.gov.ae
U.A.E. Government Health Care Procurement
- Tejari Solution: www.esupply.dubai.gov.ae
- Emirates Medical Association: www.ema.ae
- Dubai Autism Center: www.dubaiautismcenter.ae
- Emirates Autism Center: www.emiratesautism.ae
Prepared by our U.S. Embassies abroad. With its network of 108 offices across the United States and in more than 75 countries, the U.S. Commercial Service of the U.S. Department of Commerce utilizes its global presence and international marketing expertise to help U.S. companies sell their products and services worldwide. Locate the U.S. Commercial Service trade specialist in the U.S. nearest you by visiting http://export.gov/usoffices.