Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement and Tenders
Government Links
FAQs
U.S. Commercial Service Contact Information
Tab Options
Executive Summary
Market Entry
Current Market Trends
Best Prospects
Market Size
Main Competitors
Current Demand
Registration Process
Reimbursement
Barriers
Procurement and Tenders
Government Links
FAQs
U.S. Commercial Service Contact Information
Executive Summary
Croatia spent an estimated 7% of GDP on healthcare in 2018, equal to $4.3 billion, or $1,031 per capita. This is high compared to the neighboring countries but remains considerably below Western European countries. 77% of this spending was in the public sector ($3.11 billion) and 23% in the private sector ($986 million).
The Croatian government is currently undertaking an extensive reform of the healthcare sector to increase its efficiency and limit spending to more affordable levels. Nevertheless, Business Monitor International forecasts healthcare expenditures to grow by 1.9% in US dollar terms, reaching $4.74 billion by 2022. Private sector expenditure is expected to grow at a rate of 3.1% by 2021.
Croatia is a popular medical tourism destination for dental services, rehabilitation, orthopedics, dermatology, and aesthetic surgery, with a high potential for further growth. Medical tourism already drives a demand for high-quality medical, dental, and pharmaceutical products, and the demand should grow exponentially over the next three years. Additionally, medical tourism creates a demand for hospitality services in the healthcare sector, healthcare software, telemedicine, and accreditation institutions. An overview of medical tourism in Croatia is available in the Croatia Country Commercial Guide .
Croatia is a member of the European Union (EU), and it has fully implemented the new EU Medical Device Regulation.
Market Entry
Medical equipment products exported to Croatia must comply with the following requirements:
CE Certification
Directions for use accompanying the products must be in the Croatian language
The EU common Customs Tariff schedule applies to products exported from non-EU countries. All products, regardless of origin, are subject to the value-added tax (VAT). For medical products embedded in the body by surgical procedure and medical products substituting physical abilities, the VAT is 5%; for all other medical products, it is 25%.
The institutions responsible for regulatory monitoring of market entry rules and laws are the Ministry of Health (www.zdravlje.hr ), the Agency for Medicinal Products and Medical Devices (www.almp.hr ), the Agency for Quality and Accreditation in Health Care and Social Welfare (www.aaz.hr ), and the Croatian Institute for Health Insurance (www.hzzo-net.hr ).
The appointment of a local distributor or the establishment of a representative office is essential to navigate the tendering process and reach end-users throughout the country. Some of the leading local distributors are Medika (www.medika.hr ), Medical Intertrade (www.inel-mt.hr ), and Phoenix Farmacija (www.phoenix-farmacija.hr ).
Current Market Trends
Funding for healthcare in Croatia is done principally through the compulsory health insurance system, which is operated by the Croatian Health Insurance Fund (HZZO). The HZZO collects contributions from the working population and the government makes payments on behalf of those exempt, such as the elderly, the unemployed, and dependents.
The $4.31 billion budget of the HZZO provides treatment for approximately 4.1 million insured persons annually. An aging population, with 20.1% of its people older than 65 years of age, presents challenges for the limited healthcare budget. EU funds are often used for modernization and upgrades of hospital equipment. An estimated $268.5 million in EU funds will be invested in healthcare over the 2014-2020 period.
Upcoming healthcare projects include upgrades of emergency medical services, the introduction of mobile clinics, and delivery of a national cancer prevention plan. Also, a national children’s hospital worth around $120 million will be built in the next several years.
In 2018, the Croatian market for medical equipment and supplies was estimated at $359.8 million, or $86.4 per capita, primarily government-funded. It is expected that the market will expand at a rate of 7.9% per annum, reaching $496.4 million by 2022. The largest product area within the market was consumables, accounting for 22.1% of the overall total market, followed by patient aids, dental products, and orthopedics. Consumables are also a fast-growing area with 21.7% of the overall total market.
Around 95% of the medical device market is supplied by imports. Croatia’s imports of medical devices grew by 72.3% to $491.1 million in 2017, following growth of 16.3% in 2016. Most of the imports come from Germany, Belgium, China, the Netherlands, Italy, and Slovenia, while the United States (U.S.) ranks 12th. Croatia has a small domestic production sector, supplying both the domestic market and other countries of the former Yugoslavia. Exports grew by 157.6% to $169.5 million in 2017, following growth of 76.3% in 2016. This growth is mainly due to the re-exporting of mechano-therapy apparatus.
Pharmaceutical expenditures in Croatia accounted for 32.3% of healthcare expenditure or 2.35% of GDP in 2017. Total drug expenditures in Croatia in 2017 were around $1.3 billion, which represented a 9.1% increase after sharp decline in 2014 and 2015. Croatia’s pharmaceutical expenditure per capita is $311, the seventh highest per capita expenditure in the Central and Eastern Europe (CEE) Region. Prescription drugs accounted for 93% of all pharmaceutical sales.
The Croatian pharmaceutical market is highly competitive, with market share distributed among a large group of multinational and domestic companies. The domestic drug industry currently meets 35% of local demand in terms of value and 50% in terms of volume. The value of imported pharmaceuticals reached $1.34 billion in 2017, with marginal projected growth. Croatia exported $1.13 billion worth of pharmaceuticals in the same year.
Best Prospects
Consumables
Dental products
Orthopedics
Market Size
Healthcare spending (including investment)
4.3 billion (USD)
… as percent of GDP
7.0%
… of which spent on pharmaceuticals/consumables
32.3%
Hospitals, Procedures, Healthcare Professionals UN
Number of hospitals
90
…Public
74
…Private
16
Number of hospital beds
22,626
… available beds per capita
5.4
Number of surgical procedures
203.0/1,000
Physicians
15,246
Nurses
32,117
Dentists
3,830
Demographics
Population
4,179,717
Life expectancy men/women
Female: 81.2 years; Male: 74.7; Total: 77,95
Infant mortality
F: 9.6/1000
M: 9.0/1000
Total: 9.3/1000
Percent of population older than 65
20.1%
…projection, 2028
24.1%
Annual deaths
12.1/1000
…caused by [highest disease burden]
cardiovascular disease
…caused by [second highest]
cancer
Prevalence of [fastest growing disease burden]
Non-communicable diseases- cancer
Main Competitors
Croatia has a small domestic production sector, and there is very little multinational manufacturing activity.
Around 95% of the medical device market is supplied by imports. Market leaders are European and U.S. manufacturers, namely General Electric, Johnson & Johnson, 3M, Bauerfeind, Astra, Drager, etc. Some of these companies have established their own local subsidiaries, while most use third party distributors to supply the market.
Current Demand
The National Healthcare Development Strategy 2012-2020, developed by the Croatian Ministry of Health, will expand health-related IT systems in the country and restructure the hospital sector.
Improving the quality of healthcare and the efficiency of public health services in Croatia has been a government priority for the past three years. In February 2017, the European Regional Development Fund allocated $77.3 million to upgrade infrastructure and the procurement of medical devices at 12 Croatian hospitals. In March 2018, the Ministry of Regional Development signed three EU Fund healthcare grant agreements totaling $28 million. In April 2018, the Ministry of Health announced its goal to implement new clinical trial guidelines that will hasten approval and contracting procedures to increase the volume and improve access to innovative therapies.
In 2018, Croatia had 90 hospitals and most of them are in the public sector. The size of the private healthcare sector is expanding in Croatia, but the greatest increases have occurred in the number of general practitioners’ offices, which do not require as much high-tech equipment as large hospitals. Private clinics and medical practitioners account for approximately 10% of the total services provided in the health sector.
The health and dental tourism sectors are growing in Croatia, presenting high potential to boost high-quality medical equipment and pharmaceutical sales.
Approximately 25% of all drug expenditures are attributed to various groups of cardiovascular drugs. The second highest ranked group is nervous system drugs, followed by immune system/cancer treatment drugs and gastro-intestinal drugs.
Registration Process
Croatia is an EU member, hence all medical devices with CE mark can be placed on the market with simple notification. Notification of placing a medical device on the market should be submitted by a legal and natural person with a Croatian address to the Agency for Medicinal Products and Medical Devices (HALMED) in writing, not later than 15 days from the day of placing the medical device on the market.
More information on registration process is available at the Agency for Medicinal Products and Medical Devices (HALMED) website: http://www.halmed.hr/en/ .
Reimbursement
HZZO oversees pricing and reimbursement within the healthcare sector. Croatia uses the Australian Refined Diagnostic Related Groups (AR-DRG) system for healthcare services, which includes over 650 diagnoses. Pharmaceuticals are reimbursed through the basic or supplementary list. Pharmaceuticals on the supplementary list require sub-payments by the patient and are usually more expensive. Payments to the suppliers are significantly delayed (over 200 days), creating large burden for manufacturers and wholesalers.
The HZZO plans to introduce performance-based payment for primary care, introduce diagnosis-related groups in hospitals, and create one pharmaceuticals list where all drugs would require patients only to pay a VAT of 5% per prescription.
Barriers
Companies exporting medical equipment to Croatia will not encounter any direct trade barriers or quotas. Non-tariff, indirect trade barriers could include the complex system of approval for the government reimbursement list and inefficiency of the health-care system, causing long delays in payments to the suppliers.
Procurement & Tenders
In 2012, the government introduced a joint hospital procurement program for public hospitals to eliminate huge variations in the prices that different hospitals paid for identical products. A decentralized approach was adopted where nine state-owned hospitals and the HZZO were declared as the procurement coordinators and each was assigned a range of products that they would purchase for all participating hospitals. Hospitals that had historically achieved the best value for a category of products became the central purchaser/coordinator for that line of products. The system is only used for purchasing items that account for the largest share of hospitals expenditures, such as medical devices, pharmaceuticals, and energy.
Announced public procurements with full documentation are published on the HZZO website: https://eojn.nn.hr/Oglasnik/ .
FAQs
1. Is CE Mark registration accepted in Croatia? 2. What is the best way to access the market? 3. Who is the main buyer of medical devices in Croatia?
U.S. Commercial Service Contact Information
Name: Nina Cerkez nina.cerkez@trade.gov
