Healthcare Resource Guide: Croatia

 

Croatia Statistics

Summary
Market Entry

Current Market Trends

Main Competitors


Current Demand
Barriers

Registration Process

Trade Events

Government Links

CS Contact

Capital: Zagreb

Population: 4.475 million
GDP*:
USD 87.67 (2014 PPP*)

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 8.4% of GDP on healthcare in 2014, equal to $4.7bn (USD), or $1,087 (USD) per capita. Around 5% of this was spent on medical equipment. Most of the medical equipment in Croatia is imported from EU countries and the United States.

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).

Small purchases of medical equipment and supplies are usually made directly by hospitals and local health authorities, while for larger items; a tender is issued by the Institute for Health Insurance. 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 2014, the Croatian market for medical equipment and supplies was estimated at $214.3 million, or $50 per capita, primarily government funded. The largest product area within the market was consumables, accounting for 27.7% of the overall total, followed by diagnostic imaging with a market share of 13.5%. Approximately one-fourth of this market is new medical equipment. It is expected that the market will expand at a rate of 5.0% per annum, reaching $295.6 million by 2018.

The government aimed to bring the performance of the healthcare system into line with that of other EU member states through the National Health Strategy 2006-2011 and National Healthcare Development Strategy 2012-2020. 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 structural funds now available to Croatia. The strategy also anticipates the reorganization of health institutions, integrating local clinics, family practitioners, hospitals and specialized hospital services. One of the projects is construction of new facilities at the Clinical Hospital Centre Rijeka through private-public partnership that will be worth USD 500 million. The new hospital will contain 1,000 beds, as well as polyclinic, diagnostic and therapeutic facilities.


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 $210 million in 2014; this represented an increase of 6% compared with 2013. 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 4.46 billion budget of the HZZO provides treatment for approximately 4.36 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 208 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.

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 subvention list or inefficiency of the health-care system causing long delays in payments to the suppliers.

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.

Trade Events

 

None

 

Government Links

Healthcare Procurement

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

Government Health Plans

http://www.zdravlje.hr/natjecaji_i_javna_nabava/javna_nabava/plan_nabave_narucitelja


U.S. Commercial Service Contact Information

Name: Nina Radicevic
Position:
Commercial Specialist
Email:
nina.radicevic@trade.gov

Phone: +385 1 6612090


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