Current Market Trends
Procurement and Tenders
Population: 42.6 million
GDP (Purchasing Power Parity): int. $352.6 billion
Language: Ukrainian, Russian
Local tax revenues are the primary source of funding for healthcare in Ukraine. Ambulatory and hospital services are provided predominately by facilities at the regional, district or municipal levels. Healthcare expenditures in Ukraine were $4.7 billion in 2016 and are projected increase by 4.1 percent in 2017 in local currency terms (-2.3 percent in US dollar terms). Private expenditures represent around half of total health care expenditures, and 94 percent of these payments are paid out-of-pocket.
In April 2017, Ukraine's Cabinet of Ministers approved a legislative package for healthcare system reform. These laws are now under consideration by Parliament. If the package is adopted, it will take three years to launch the new healthcare system fully. Under this new system, a new health insurance system would cover a broad range of services, while a new national purchasing agency will help prevent corruption in the healthcare system.
There is no accurate statistical data on the size of the Ukrainian medical equipment market. According to the BMI forecast, the Ukrainian medical device market will record double-digit growth over the 2015-2018 period, expanding moderately in U.S. dollar terms due to local currency depreciation. In 2016, the Ukrainian medical device market was worth $288 million, a 3.7 percent increase over 2015. Multiple factors are driving growth: extra funding allocated for the purchase of cardiology equipment in the 2017 national budget; an ongoing World Bank project approved in March 2015; Japanese grants for modernization of medical equipment at several hospitals; the Ministry of Health's plans to expand the network of clinics in rural areas; and the need to rebuild or re-equip healthcare facilities that were destroyed during the conflict in eastern Ukraine.
Imports account for 90 percent of medical device sales in Ukraine. Major trade partners in this segment include:
U.S. - particularly strong in the supply of orthopedics and prosthetics, and diagnostic imaging equipment
China - strong in the supply of consumables and patient aids
Germany – the leader in dental imports
Japan – strong in imaging equipment imports
The U.S. was the second leading supplier (after China) in 2016, with imports worth $32.8 million, or 12.6 percent of total sales. The U.S. accounted for almost 25 percent of orthopedics and prosthetics sales.
The Ukrainian market is open to advanced medical equipment, offering ease of use and cost savings. Receptivity to used medical equipment is average. On one hand, there is a demand from end-users, but on the other hand, used equipment cannot be purchased through government tenders. However, private hospitals and clinics are in the market for used medical equipment.
U.S. companies entering the Ukrainian market should approach the market with a long-term perspective. Business in Ukraine is often based on relationships, so selecting a good local partner and/or establishing a local office are crucial to minimizing risk and long-term success. To find a potential partner, we recommend using the U.S. Commercial Service’s International Partner Search and/or Gold Key programs to conduct initial screening for prospective partners. (For more information please refer http://www.export.gov/ukraine ) U.S. companies should use appropriate due diligence in selection of partners and should be mindful of the parameters of the Foreign Corrupt Practices Act.
Kyiv is not the only trade hub in Ukraine. Look for distributors that have nationwide capabilities, including those located in the cities of Dnipro, Lviv, Odessa, Zaporizhzhya, and Kharkiv. These regions are considered important industrial centers in Ukraine and are densely populated. Covering the Ukrainian market from regional offices in Poland or Russia is not an effective approach. Ukrainian buyers are reluctant to go through regional offices, preferring to order direct for the manufacturer/wholesaler. On-the-ground presence is very important to successful business development in Ukraine.
Joining the American Chamber of Commerce and obtaining experienced legal and accounting support are other important considerations when considering doing business in Ukraine.
Public health priorities as announced by the GOU include strengthening primary health care, optimizing the number and the structure of hospitals in Ukraine, responding to disease outbreaks, providing vaccinations, diagnosing health threats, providing water and food safety, and providing a safe living environment.
In this context, the Ministry of Health is highlighting ten key healthcare reform priorities:
Though Ukraine has a strong scientific research base, capable of developing highly advanced treatments and products, it lacks an accompanying strong manufacturing sector. Domestic manufacturers produce a limited range of equipment including radiology, electrocardiography and ultrasound machinery, refrigeration and cryogenic equipment, specialized medical furniture, orthopedic appliances, respiratory anesthetic equipment, hearing aids, surgery and dentistry tools, sterilizing equipment, electro-diagnostic equipment, and electrical stimulators.
About 250 companies are developing and producing medical equipment in Ukraine. Domestic medical device production was worth over $57.9 million in 2016. Historically, exports tended to be largely at the lower end of the technology scale, but in 2016, diagnostic imaging exports accounted for nearly 40 percent of the total. Around half of exports are destined for other former Soviet countries.
As indicated, imports account for 90 percent of medical device sales in Ukraine. The major suppliers are China, the U.S., Germany, and Japan. The U.S. was the second leading supplier in 2016 (after China), with imports worth $32.8 million, or 12.6 percent of total sales.
Ukraine is moving towards harmonization with EU standards in the field of medical equipment/devices. In July 2015, a new national conformity assessment procedure governing the registration of medical devices was introduced. New products can enter the Ukrainian medical device market if they conform to the technical regulations, which are based on the EU Directives for medical devices. The new system introduces the following requirements for Ukrainian medical device registrations:
Although the new Ukrainian registration system bears many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are planned for devices already approved or cleared for sale in major markets such as Europe or the US. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities, even if those sites are already ISO 13485-compliant.
Documentary expertise, on-site manufacturing inspections and testing of samples of medical devices is being performed by national authorized bodies (analogue of notified bodies in EU). A list of state and private bodies that have been granted accreditation from the National Accreditation Administration of Ukraine and the Ministry of Economic Development and Trade can be found at http://www.moz.gov.ua/docfiles/an_20150724_0_dod2.pdf (in Ukrainian)
Self-declaration is applied to:
Conformity assessment involving authorized body is required for:
The conformity assessment procedure with the involvement of an authorized body may be conducted using one of the following routes:
1. In form of assessment of the Quality Management System at the manufacturing site (the on-site inspection), which results in issuing of the conformity certificate for medical devices valid for 5 years related to the quality management certificate valid for 3 years.
2. In form of conformity assessment of each batch, which implies issuing of the certificate for the certain batch (shipment) of medical devices after documentary expertise and sample examinations.
In April 2017, the Cabinet of Ministers of Ukraine approved a package of four bills on healthcare system reform, which is to be considered by Parliament. A major part of the healthcare reform revolves around the long-awaited introduction of a public health insurance system. The MOH plans to implement it over a three-year period, creating a system that would finance primary care by mid-2017, secondary care by 2018 and tertiary care by 2019.
Acting Health Minister Ulana Suprun noted that the MOH will set the tariffs for secondary-level medical services using a Diagnostic Related Groups (DRG) system. The government is currently determining the minimum group of health services that will be available to all patients under the insurance system. Patients will need to make co-payments for specialized treatments, complex or expensive surgeries or specific types of therapy.
The current healthcare system is largely funded by general government revenues raised through taxation. Ukrainian citizens are entitled to a comprehensive guaranteed package of healthcare services, provided free of charge at the point of use in public healthcare facilities: emergency care; outpatient polyclinic care; inpatient care for acute conditions and emergencies requiring intensive treatment and first aid for the rural population. However, in practice, patients need to pay out of pocket to access services due to insufficient government financing of the health system. Private expenditure represents around half of total healthcare expenditure, and 94% of this consists of out-of-pocket payment.
Although the new Ukrainian registration system will bear many similarities to the CE Marking process for medical devices in Europe, no simplified or expedited market pathways are available for devices already approved or cleared for sale in major markets such as Europe or the U.S. Manufacturers should also be aware that Ukrainian regulations will require inspection of facilities even if those sites are already ISO 13485-compliant.
According to current regulations, government tenders are to be non-discriminatory against foreign bidders.
Procurement and Tenders
Ukraine’s implementation of an e-procurement system in August 2016 presents opportunities for American companies to participate in Ukrainian public tenders.
American suppliers interested in current public procurement opportunities in Ukraine may register for notifications at the Ukrainian Public Procurements Official National Web Portal PROZORRO: https://tender.me.gov.ua/EDZFrontOffice/ and at the PROZORRO website http://prozorro.org/.
Name of event: Public Health
Location: Kyiv, the International Exhibition Center
Dates: October 3-5, 2017
English language website: http://www.publichealth.com.ua/eng/index.php
Description: Public Health is a medical equipment (including dental, clinical laboratory and optical) and pharmaceuticals trade show in Ukraine. Public Health is held annually in October. The show organizer for Public Health is Premier Expo, a part of the International Trade Exhibitions Group, UK.
U.S. Commercial Service Contact Information
Name: Olena Stephanska,
Position: Commercial Specialist
Healthcare spending (including investment)
... as percent of GDP
5.04% (2016 est); 7.1% (2014)
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
Number of hospital beds
... available beds per capita
7.43 per 1000 inhabitants
Number of surgical procedures
2,973,790 (2016 est.)
213,477 (2016 est.)
42,584,542 (as of January 1, 2017)
Life expectancy men/women
7.4 deaths/1,000 live births
Percent of population older than 65
14.7 deaths/1,000 population (2016)
...caused by [highest disease burden]
Heart and Vascular Diseases
...caused by [second highest]
Prevalence of Heart and Vascular diseases
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