Serbia - 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: 2019-10-13

Overview

The biggest customer for medical equipment and pharmaceutical products in Serbia is the National Health Insurance Fund. In 2019, the Serbian healthcare budget was an estimated USD 340 million. Compared to other countries in the region, Serbia has a relatively high healthcare expenditure ratio of 10 percent of GDP.

The medical equipment and supplies market size is roughly USD 240 million. The market rose 4.5 percent this year, with further growth of three to five percent annual growth expected in the next few years. Imports account for approximately 88 percent of the market, in part because of the implementation of health reforms that increased demand for new equipment. The leading medical equipment suppliers are EU-based manufacturers. Approximately 15 percent of medical equipment imports are from the United States, although the actual share of U.S. imports is higher as some products are shipped from European subsidiaries. Domestic production of medical equipment and devices is small and largely focuses on medical supplies such as bandages and syringes. Chinese firms are increasing their market share, specifically in the area of ultrasound solutions equipment and laboratory equipment. (The above data do not include procurements and expenditures related to the COVID 19 pandemic. The end figures may by significantly different than stated above.)The Serbian government has committed to improving and modernizing the national healthcare system, which is in desperate need of reform. In recent years, the government has overseen an overhaul, with the help of external financing from international organizations, such as the World Bank. Equipment upgrades are part of this goal.

Serbia’s healthcare system is financed by compulsory health insurance contributions comprising 10.3 percent of payroll taxes. The system provides easy access to comprehensive health services for the entire population. A majority of hospitals are public (state-owned).   

Serbia’s private health insurance market had been underdeveloped for some time, with private-sector practices operating mostly on an out-of-pocket basis outside of insurance networks. The private sector is growing however, including major chains like BelMedic, MediGroup, a range of smaller and specialty clinics, as well as laboratory and diagnostic services, growing both with out-of-pocket services and expanding private health insurance options.

The Ministry of Health is the major decision-maker in the Serbian healthcare market.  It develops health policies and budgets, monitors the work of state-owned health institutions, and approves plans for purchases of medical equipment. The Public Procurement Act requires open tenders for all purchases. Most purchases are made by publicly owned institutions. However, private medical practitioners present some opportunities for sales of dialysis and diagnostic-imaging equipment, other medical devices, and consumables.

The Medicines and Medical Devices Agency of Serbia (ALIMS) is in charge of issuing marketing authorizations for medicinal products and medical devices. The Medical Devices Law (2017) regulates the following: conditions for the marketing of medical devices and their use in Serbia; clinical investigation of medical devices; vigilance; monitoring and technical assessment of medical devices on the market; assessment of the compliance of medical devices with essential requirements; advertising; the labelling of medical devices and supervision in this field; as well as other relevant issues.

Though Serbia has adopted most European regulations, the CE mark has not yet been recognized, so medical products from the EU have to pass the marketing authorization process, which is a simpler procedure than the one for products without the CE mark. Companies often express concern regarding delays in registering medical devices.

Leading Sub-Sectors

U.S. medical equipment has an excellent reputation in Serbia for its superior quality and advanced technology. However, U.S. exporters face difficulties ranging from technical specifications written for EU and Chinese manufacturers, to more favorable financing and lower prices for equipment coming from these markets. The best sales prospects for U.S. medical equipment include:

  • linear accelerators
  • cardiovascular diagnostic equipment
  • non-invasive surgical devices
  • anesthesia and intensive care equipment
  • diagnostic imaging (CTs, MRIs)
  • radiation therapy equipment
  • ultrasound equipment
  • urology equipment
  • laboratory and testing equipment
  • tissue and blood bank related equipment
  • ultra-violet/infra-red equipment used in medical, surgical, dental, or veterinary sciences
  • medical lasers

Local distributors indicate that there is a large demand for diagnostic tests for drugs, pregnancy, and various illnesses, with special interest in importing new U.S. products that have no European equivalents. Digitization of various technology processes in hospitals, as well as improvement of IT and management systems in hospitals will gain in importance in the coming years due to the Serbian government’s focus on cross-sector digitalization.

Opportunities

There are opportunities in the Serbian market for U.S. manufacturers of sophisticated diagnostic equipment (e.g., imaging equipment), particularly ultrasonic diagnostic equipment, MRIs, scanners, and endoscopes. Pacemakers, nuclear medical instruments, and clinical laboratory equipment, as well as health informatics equipment, home healthcare and rehabilitation equipment, and patient monitoring systems including intensive care units, are expected to be in high demand in the next few years.

The Ministry of Health and the Health Insurance Fund are looking for innovative ways to work with medical equipment suppliers, including arranging public-private partnerships in which a company would equip and administer a certain medical center or hospital unit.

Medium and long-term procurement opportunities include the following: information systems (to be developed through the National Health Insurance Fund), training, public information and technical assistance, and support for outpatient and inpatient care. Hospitals routinely procure diagnostic equipment, modern patient monitoring systems, and hospital management systems.

Web Resources

For more information on market entry strategies contact:

Belgrade@trade.gov