Serbia - Medical Equipment Serbia – Medical Equipment
Overview
In 2016, the Serbian market for medical equipment and supplies was estimated at $ 220 million, or USD 27 per capita. The market rose 4.5 percent compared to the previous year. Further growth of three to five percent annually between 2016 and 2020 is expected, reaching USD 300 million. 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 10 percent of medical equipment imports are from the United States, although the actual share of U.S. imports is higher as some is shipped from their European subsidiaries. Domestic production of medical equipment and devices is small and largely covers medical supplies such as bandages and syringes, as well as low-tech and small amounts of hi-tech medical equipment.The Medical Device Market (In mill. USD)
| Medical Devices | 2015 | 2016 | 2017 (e) | 2017 (e) |
| Total Local Production | n/a | n/a | n/a | n/a |
| Total Exports | 12.000 | 13.000 | 14.000 | 14.000 |
| Total Imports | 195.000 | 200.000 | 200.000 | 210.000 |
| Imports from the US | 26.000 | 26.000 | 30.000 | 30.000 |
| Total Market Size | 210.000 | 220.000 | 220.000 | 230.000 |
| Exchange Rate: 1 USD | 110 | 120 | 125 | 130 |
Source: Serbian Bureau of Statistics and independent experts EPISCOM Report: The Medical Device Market: Serbia
The Serbian government has committed to improving and modernizing the nationalized healthcare system, which is in desperate need of reform. In recent years, the government has undertaken an extensive program of renovation, with the help of external financing from international organizations, such as the World Bank. Equipment upgrades are part of this goal.
The healthcare system in Serbia is financed by compulsory health insurance contributions, based on 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). Owing to Serbia’s underdeveloped insurance market and state healthcare policy, the private sector share is minimal. The public healthcare network in Serbia includes a total of 344 healthcare institutions: 210 primary healthcare entities, 76 secondary level institutions (40 general hospitals and 36 special hospitals and rehabilitation centers), and 29 tertiary care institutions. The total number of beds in state hospitals stood at 38,200 at the end of 2014.
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.
In accordance with the Medical and Medical Devices Law, the Medicines and Medical Devices Agency of Serbia (ALIMS) is in charge of issuing marketing authorizations for medicinal products and medical devices, performing laboratory quality control of medicinal products and medical devices, collecting and processing statistical data on trade, and consumption of medicinal products and medical devices.
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 complain that they have to wait a very long time to register medical devices.
Leading Sub-Sectors
U.S. medical equipment has an excellent reputation in Serbia for state of the art technology, quality, and reliability. However, technical assistance concerns (both real and perceived) are seen as obstacles to the growth of U.S. imports. The medical equipment market is price-sensitive. 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
- apparatuses based on the use of X-rays of alpha, beta or gamma radiation treatments
- Medical lasers
- endoscopes
Opportunities
There are opportunities in the Serbian market for U.S. manufacturers of sophisticated diagnostic equipment such as imaging equipment, especially 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 become good opportunities for U.S. companies in the next few years.The Ministry of Health is looking for innovative ways to work with medical equipment suppliers and is considering the creation of PPPs in which a company would equip and administer a certain medical center or hospital unit. This is in the conceptual stage, and the Ministry and the Health Insurance Fund are willing to listen to different proposals.
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
- Ministry of Health of the Republic of Serbia
- Health Fund of the Republic of Serbia
- Medicines and Medical Devices Agency of Serbia
- Association of Medical Devices Distributors in Serbia
- Institute of Public Health of Serbia