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Healthcare Resource Guide: Croatia

Croatia Statistics

Summary Market Entry
Current Market Trends

Main Competitors

Current Demand

Registration Process Barriers
Trade Events

CS Contact

Capital: Zagreb

Population: 4.238 Million

GDP*: $57.11 (2014 *Market prices)

Currency: Croatian Kuna

Language: Croatian

Summary

In July 2013, Croatia became the 28th member of the EU. On the accession date new medical device legislation was introduced, replacing the previous Medical Devices Act of 2008.

According to the data provided by the World Health Organization (WHO), Espicom estimates that Croatia spent an estimated 6.7% of GDP on healthcare in 2015, equal to $3.14bn (USD), or $742 (USD) per capita. Around 7% of this was spent on medical equipment. Most of the medical equipment in Croatia is imported from EU countries and the United States.

Consumables, dental products, orthopedics and prosthetics, and diagnostic imaging are product areas with the best prospects. Health IT sector will also present great opportunities in the upcoming years.

Market Entry

Medical equipment products exported to Croatia have to comply with the following requirements:

  • CE Certification
  • Directions for use accompanying the products must be in 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 body by surgical procedure and medical products substituting physical disabilities the VAT is 5%, and for all other medical products 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).

In 2012, the government introduced a joint hospital procurement program for public hospitals in order 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 money for a particular 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.

The appointment of a local distributor will therefore be 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

In 2015, the Croatian market for medical equipment and supplies was estimated at $211 million, or $50 per capita, primarily government funded. The largest product area within the market was consumables, accounting for 27% of the overall total, followed by dental products and orthopedics with a market share of 16% and 14% respectively. Approximately one-fourth of this market is new medical equipment. It is expected that the market will expand at a rate of 5% per annum, reaching $296 million by 2018.

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. Health IT is an important part of the strategy, and some of the goals have already been achieved - the implementation of a prescription system, followed by an e-waiting list, and a centralized information system. Even though informatization of healthcare has been in place for 10 years, it is expected that it will be fastened with use of EU funds available to Croatia. The strategy also anticipates the reorganization of health institutions, integrating local clinics, family practitioners, hospitals and specialized hospital services.

Improving the quality of healthcare and the efficiency of public health services in Croatia has been the main priority in 2014 and 2015. In May 2014, the World Bank approved a USD103.5 million project with main objectives to improve the healthcare delivery system, rationalize the hospital network, strengthen the government's capacity to develop and monitor effective health sector policies and promote effective public health. The closing date of the project is June 2018. Moreover, Ministry of Health conducted health technology analysis during 2014, where the priorities aimed for attaining the EU quality level of service were set. As a result, the Ministry allocated USD 36 million for acquisition of new equipment, including CT and MRI devices. In addition to improvements of the existing hospitals, construction and equipping of additional hospital centers in Pula, Rijeka and Bjelovar are planned for 2016-2017.

Main Competitors

Croatia has a small domestic production sector and there is very little multinational manufacturing activity.

Around 92% 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 companies will use third party distributors to supply the market.

Current Demand

Croatia imported medical devices valued at $222 million in 2015; this represented an increase of 6% compared with 2014. Croatia has a small domestic production sector, supplying both the domestic market and other countries from the former Yugoslavia. Imports fell in all products areas except for consumables and dental products. Even though imports have fluctuated in recent years, the general trend has been upward, from USD 109.2 million in 2002.

Funding for healthcare in Croatia is principally through the compulsory health insurance system. It was introduced in 1993 and is operated by the Croatian Institute for Health Insurance (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 USD 3.3 billion budget of the HZZO provides treatment for approximately 4.2 million insured persons annually in 49 public health centers, 22 general hospitals, 12 clinics, 40 special hospitals and 363 polyclinics.

Total spending on medical equipment, surgical instruments, accessories, laboratory equipment and various supplies in Croatian hospitals amounts to USD 200 million, of which approximately USD 45 million is spent on medical equipment. Clinical centres in Zagreb and Rijeka are the most active buyers. The most prospective product areas of the medical device market are orthopaedics and prosthetics, diagnostic imaging, and consumables.

Registration Process

The Agency for Medicinal Products and Medical Devices (HALMED) is responsible for placing medical equipment on the Medical Devices and Homeopathic Products Register. All applications submitted to HALMED are preceded in accordance with EU legislative. In order to register a medical device, manufacturers should submit a written application to HALMED, accompanied by the extensive documentation.

More information on registration process is available at www.almp.hr.

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 approving for government reimbursment list or inefficiency of the health-care system causing long delays in payments to the suppliers.

Trade Events

None

Government Links:

Healthcare Procurement:

https://eojn.nn.hr/Oglasnik/

Government Health Plans:

https://zdravlje.gov.hr/javna-nabava-1473/1473

U.S. Commercial Service Contact Information

Name: Nina Radicevic

Position: Commercial Assistant

Email: nina.radicevic@trade.gov

Phone: +385 1 6612090


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