Ukraine - Medical EquipmentUkraine - Medical Equipment
Overview
Data in USD thousands
|
2017 |
2018 |
2019 | 2020 (forecast) |
Total Local Production |
72.7 |
81.7 |
95.7 | 97.0 |
Total Exports |
30.0 |
33.0 |
36.0 | 42.0 |
Total Imports |
332.1 |
397.1 |
465.0 | 494.6 |
Imports from the U.S. |
39.4 |
55.4 |
58.0 | 60.0 |
Total Market Size |
374.8 |
405.8 |
524.7 | 549.6 |
Exchange Rate: 1 USD |
27.2 UAH |
29.3 UAH | 29.5 UAH | 30.8 UAH |
Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
Data Source: National Sources/BMI; Total Imports and Imports from U.S.: TradeStat Express*There is no accurate statistical data on the size of the medical equipment market. On January 1, 2018, new healthcare reform laws became effective in Ukraine. These reforms are the first comprehensive change to the country's health system since independence in 1991. This program was launched on the primary medical care level starting from July 1, 2018 and will be fully implemented on all levels of medical care beginning January 1, 2020. The cost of medical services is covered by payments made to healthcare institutions by the newly created National Health Service (NHS). As of the beginning of 2019, 97% of healthcare facilities had switched to the new financing model, and around 20% of these were private institutions. The NHS paid $128.6 million to healthcare facilities in 2018, and $49.6 million in January 2019.
Under the new system, patients can choose their own doctor, and they are now in the process of signing declarations that will be included in the electronic health database. As of April 2019, 26 million people, equal to nearly 60% of the population, had signed declarations with family physicians, therapists or pediatricians.
A list of medical services, medical devices and pharmaceuticals to be provided to patients free of charge will be adopted each year as part of the state budget. The costs of emergency, primary, secondary, tertiary and palliative care, including services and medications, will be fully covered by the state under the healthcare guarantees program. At least 5% of GDP will be allocated each year for the healthcare guarantees program.
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, in local currency terms, over the 2018-2020 period.
In 2019, the Ukrainian medical device market was worth $524.7 million, and is projected to reach $549.6 million in 2020 (Source: National Sources/BMI). Multiple factors are driving the growth: new healthcare legislation, which changes the way healthcare is financed; comprehensive reforms in the hospital sector; an ongoing World Bank project that was approved in March 2015; and Ministry of Health plans to expand the network of clinics in rural areas.
In 2019, imports accounted for 90 percent of medical device sales in Ukraine. Major suppliers were China, the U.S., Germany, and Japan. The U.S. share was about 12 percent of total imports, and almost 25 percent of orthopedics and prosthetics imports.
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 $95 million in 2019. Historically, exports tended to be largely at the lower end of the technology scale, but in 2018, diagnostic imaging exports accounted for nearly 40 percent of the total. Around half of exports are destined for other former Soviet countries.
Ukraine continues to move towards harmonization with European standards in the field of medical equipment/devices. In July 2015, a national conformity assessment procedure governing the registration of medical devices was introduced. New products can enter the Ukrainian medical device market if they conform with the technical regulations that based on the EU Directives for medical devices. The new system introduces the following requirements for Ukrainian medical device registrations:
- Foreign registrants must appoint Authorized Representatives based in Ukraine
- Expanded list of documentation and sample submissions required for registrations
- Manufacturing site inspections for Classes I, IIa, IIb and III
- Special symbols of national conformity are required for medical devices imported into Ukraine
- National conformity certifications are valid for five years
Leading Sub-Sectors
Diagnostic imaging equipment (ultrasound, computer tomography, magnetic-resonance tomography)- Laser surgery devices
- Stents, pacemakers, and other equipment used in the treatment of heart conditions
- Orthopedics and prosthetics
Ukraine’s implementation of 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 and at PROZORRO.
The World Bank’s $261 million “Serving People, Improving Health” project approved in March 2015 runs until September 2020. The project provides financing for medical infrastructure aimed at the prevention, early detection, and treatment of cardiovascular diseases and cancer in eight regions across the country. The project will also finance activities clustered around five thematic areas: payment system reform, e-Health, public health, information and communications, and capacity building.
Web Resources
Trade Events- Public Health, Ukraine’s major medical equipment & pharmaceutical industries trade show – October 1-3, 2019, Kyiv, Ukraine