Ukraine - Country Commercial Guide
Medical Equipment

This is a best prospect industry sector for this country. Includes a market overview and trade data.

Last published date: 2021-09-24

Overview

Data in USD million

 

2020
(estimated)

2021
(forecast)

2022
(forecast)

2023
(forecast)

Total Local Production

165.3

170.2

181.9

200.5

Total Exports

33.0

36.0

42.0

46.0

Total Imports

529.4

536.9

596.3

658.7

Imports from the U.S.

52.9

54.0

60.0

66.2

Total Market Size

661.7

671.1

736.2

813.2

Exchange Rate**: 1 USD

28.3 UAH

28.6 UAH

28.7 UAH

28.9 UAH

  • The 2021 budget expenditures for healthcare are planned at approximately $5.7 billion, 3.5% of country’s GDP, an increase from $4.2 billion in 2020 (2.6% of country’s GDP). Healthcare reform started in 2018, being the first comprehensive change to the country’s health system since independence in 1991. The cost of medical services is covered by payments made to healthcare institutions by the newly created National Health Service (NHS). A list of medical services, medical devices and pharmaceuticals to be provided to patients free of charge is adopted each year as part of the state budget. Introduction of reform led to a decrease of private healthcare expenditures consisting of out-of-pocket payments from about 51% in 2017 to 25% in 2020.Total Market Size = (Total Local Production + Total Imports) – (Total Exports)
  • Data Source: National Sources/BMI; Total Imports and Imports from U.S.: TradeStat Express; Ministry of Economy of Ukraine**
  • *There is no comprehensive statistical data on the size of the medical equipment market available.

The Ukrainian medical device market, estimated at $661.7 million as of 2020, has experienced significant growth over the last several years. While COVID-19 negatively impacted the market in 2020, a series of health finance reforms, the country’s wide-ranging hospital sector, an ongoing World Bank support program, and the Ministry of Health’s expansion plans for rural areas, all expect to contribute to substantial market growth in 2021 and beyond. Recent programs have sought to retool facilities in priority areas for healthcare delivery, such as in imaging, radiation, and robotics surgery technologies. Primary and emergency care facilities in pilot regions have also been retooled for future needs. The biggest portion of the market is via the state-funded centralized procurement program and regionalized programs of healthcare support. As the domestic industry continues to develop and with limited resources, currently up to 80% of medical equipment is imported, providing numerous opportunities for exporters. Major suppliers include China, Germany, and Japan. The U.S. share is about 10 % of total imports, and almost 25 % of orthopedics and prosthetics imports.

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 is estimated at $170.2 million in 2021. Consumables, in particular individual protective products such as masks, contributed to the growth. Historically, exports tended to be largely at the lower end of the technology scale, but since 2018, diagnostic imaging exports account for nearly 40 % 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 are 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

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). 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 the website of the State Service of Ukraine on Medicines and Drugs Control (available only in Ukrainian). 

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
Pulmonary (ventilation machines)
Patient monitoring

Opportunities

Ukraine’s implementation of the 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/.

The World Bank’s $261 million “Serving People, Improving Health” project approved in March 2015 received $135 million of additional financing in April 2020. The additional financing will support improving the efficiency and quality of health services, particularly for non-communicable diseases in line with health sector reforms, and to prevent, detect and respond to the threat posed by COVID-19.

Resources

Ministry of Health of Ukraine

COVID 19 pandemic in Ukraine

Trade Events

Public Health, Ukraine’s major medical equipment & pharmaceutical industries trade show – October 6-8, 2021, Kyiv, Ukraine