Current Market Trends
Procurement & Tenders
Population: 7.1 million (without Kosovo)
GDP: $39.37 billion (2017 est.)
Currency: Serbian dinar (RSD)
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% of payroll taxes. The system provides easy access to comprehensive health services for the entire population. Despite that, 38% of expenditure for healthcare services in Serbia are paid out of pocket. A majority of hospitals are public (state-owned). However, with the development of a private insurance market, private healthcare services and institutions experienced significant growth for the last ten years. The public healthcare network in Serbia includes a total of 355 healthcare institutions, including 158 primary healthcare entities, 75 secondary level institutions (41 general hospitals and 36 special hospitals and rehabilitation centers), 4 clinical centers and 4 military healthcare institutions. The total number of beds in state hospitals stood at 41,788 at the end of 2016. According to the official statistics, 10% of the total number of medical practicioners are working in the private sector.
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. Private medical practitioners present some opportunities for sales of dialysis and diagnostic imaging equipment. The Medicines and Medical Devices Agency of Serbia (ALIMS) (www.alims.gov.rs) is in charge of issuing marketing authorizations for medicinal products and medical devices.
According to the new Law on Medical Devices, effective as of December 2018, CE mark will be recognized, while other products have to pass the marketing authorization process by ALIMS. Even though Serbia has adopted most of the European regulations, the CE mark has not yet been recognized for innovative pharmaceutical products. All drugs have to pass the marketing authorization process. This procedure is more simplified.
U.S. medical devices and pharmaceutical products have an excellent reputation and a strong market position in Serbia. Best prospects are products and medications for cardiovascular treatments, bone health, orthopedics, cancer treatments, dementia care, and cheaper and more efficient screening and diagnostic technologies, etc.).
The appointment of a local distributor will be essential to navigate the tendering processes, both for medical devices and pharmaceuticals, and reach end-users throughout the country.
Current market trends reflect increasing life expectancy (74.6 years) and unhealthy lifestyles (obesity and heart disease are on the rise) in Serbia. Devices used to monitor symptoms and manage disease are in increasing demand. The most common cause of death is circulatory system problems (heart disease, stroke etc.). Serbs continue to be heavy smokers and the air in many industrial cities is somewhat polluted. Growing interest in innovative diagnostics devices and biological treatments could generate new opportunities for U.S. medical equipment providers, as well as pharmaceutical.
E-health has been a main topic in Serbia for the last five years. The Serbian Ministry of Health introduced basic concept through e-appointments and e-prescription, which should help to establish a program for the national introduction of eHealth in the future. The introduction of eHealth faces challenges including the low motivation of doctors, patient and, state institutions, limited legislation in this area and a lack of financing.
o Linear accelerators
o cardiovascular diagnostic equipment
o non-invasive surgical devices
o anesthesia and intensive care equipment
o diagnostic imaging (CTs, MRIs)
o radiation therapy equipment
o ultrasound equipment
o urology equipment
o laboratory and testing equipment
o tissue and blood bank related equipment
o ultra-violet/infra-red equipment used in medical, surgical, dental, or veterinary sciences
o apparatuses based on the use of X-rays of alpha, beta or gamma radiation treatments
o Medical lasers
Medicines and Medical Devices Agency of Serbia (ALIMS) is in charge of issuing marketing authorizations for medicinal products and medical devices. Although Serbia is not yet EU member, it has adopted most European regulations. For medical devices, EU certificate and approval will be mandatory as of December 2018, Medical Devices Law (2017). The registration process for pharmaceuticals is more complicated and time consuming (ALIMS).
Pricing and reimbursement policies in Serbia are regulated by two acts: Price Decree for Drugs for Human Use and the Decree on the Criteria and Procedure for the Reimbursement List. These decrees established the criteria for setting maximum prices for all medicines, whether reimbursed or not reimbursed/purchased by state. The maximum wholesaler price permitted is set at an adjusted average of wholesaler prices in three reference countries, i.e. Slovenia, Croatia and Italy. Based on the Law on Drugs and Medical Devices, guidelines for the PDL (positive drug list) for the reimbursement of drugs consists of products grouped under their anatomical-therapeutic-chemical (ATC) code.
There are no restrictions on imports, provided the medicines are registered or approved for use in Serbia. The import duties range from 1-5%. Customs duties are not applied to the imports from the countries from the region that Serbia has signed Free Trade Agreements with. According to Serbian tax regulation, all products regardless of origin are subject to a 20% value added tax, which is borne by the final customer (hospital or patient), except orthotic and prosthetic devices and medical devices - products that are surgically implanted in the body, which are subject to an 8% value added tax.
Procurement & Tenders
Name of event: Medident
Date: October 11 – 13, 2018
English language website: www.sajam.rs/en/calendar-2018/medident/
Description: International exhibition of medical, laboratory, dental, veterinary equipment and instruments, pharmaceutical and other equipment and medical services. The Accompanying Programme features up-to-date scientific and expert issues in different fields of medicine, laboratory diagnostics and dentistry.
U.S. Commercial Service Contact Information
Name: Zorica Mihajlovic
Position: Senior Commercial Specialist
Phone: +318 65 384 8990
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.
... as percent of GDP
Hospitals, Procedures, Healthcare Professionals UN:
Number of hospitals
Number of hospital beds
... available beds per capita
5.9 beds per 1.000 population (2016)
...of which in general hospitals
...of which in specialized clinics and rehabilitation centers
Life expectancy men/women
72.8 years / 78.8 years (2017)
5.8 deaths/1,000 live births (2017)
Percent of population older than 65
13.6 deaths/1,000 population (2017)
Diseases of the circulatory system
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