Hungary Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in hungary, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
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Medical Technologies
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Overview

The Hungarian medical technology industry is a relatively concentrated sector with almost 180 enterprises engaged in export-driven manufacturing, comprising 5.3% of Hungarian exports.  The life sciences sector employs 53,000 people in Hungary. Some of these Hungarian companies have wider portfolios, such as 77Elektronika, Mediso, Sanatmetal, Innomed Medical Zrt., Lasram Engineeing Ltd.  The country has a solid base for manufacturing a range of medical devices, however, given the small market, it is challenging for domestic production to compete with Western quality and innovation.  The Hungarian MedTech sector includes cutting-edge research and development partnerships with universities with research areas in medical imaging, electric and biosensor devices, as well as lab diagnostics. 

Local production consists mainly of electro-medical equipment, ventilators, blood pressure equipment, lab diagnostic kits, cardiology and radiology devices, surgical and dental supplies, apnea alarms, incubators, infusion pumps, mechanical medical supplies, maternity products, surgical laser, X-ray, CT, and IVD equipment.  Local production and imports generally complement each other. 

Over the past decade, over 8,000 health professionals have left Hungary for other European countries. Currently Hungary has one of the lowest ratios of doctors per inhabitant in the EU. Despite government efforts, Hungarian doctors are leaving the country for better pay and working conditions in Western Europe, leaving the country’s healthcare system to deal with understaffed facilities and longer waiting periods. In 2022, more than 800 Hungarian doctors requested a certificate to practice outside of the country.  This could lead to a disastrous situation in a country with just over 33,000 doctors for 9.7 million population, or roughly 3.5 doctors per 1,000 inhabitants, which is lower than the average of 3.9 for the EU. In 2022, departments of Hungarian hospitals were shut for a total of over 46,000 days due to lack of staff or shortage of necessities.  According to data by a health insurance company, around 40,000 people in March 2023 were in line for surgical procedures and waiting times had reached all-time highs.  Observing discrepancies between Hungary and its neighbor Austria is illustrative.  The biggest difference is the patient and nurse ratio. In Austria, one nurse would take care of one or two patients, while in Hungary, there could be four or five patients.  Between 2011 and 2021 Hungarian doctors moved mostly to the UK, Germany, Austria, and Sweden. In 2020, the government spent only 7.3% of GDP on healthcare, compared to a 10.9% EU average. The state rolled out an 11% pay-raise for healthcare professionals in February 2023, meaning doctors are now paid a gross of EUR 1,800 per month.  Working conditions, including the availability of equipment also influence doctors’ decisions to leave Hungary. 

The largest private institutions now offer a comparable work environment and a similar level of quality as the best Austrian or German private hospitals. The return of Hungarian doctors who previously worked abroad primarily strengthens the medical groups of the market-leading private providers. Private healthcare providers offer a wide range of services for relatively high prices, e.g., cardiology consultation for EUR 90 and arthroscopic knee surgery starting at EUR 1,000. These prices are often out of reach for the average Hungarian as the median salary is EUR 950 per month. Patients in state healthcare, meanwhile, may have to wait over a year for knee surgery.  As the pay in the private sector is significantly higher than in state hospitals, the gap between public and private care is widening with a relatively small portion of the population being able to access private healthcare.

Hungary’s bidding system, requiring manufacturers to submit blind price reductions to the National Health Insurance fund every six months in order to keep consumer prices low, delays launching of new medicines and limits their availability.  During the COVID pandemic, the government granted a compulsory license for a treatment despite having access to the medicine via the EC’s Joint Procurement Agreement with the patent holder. In legal proceedings, the government rejected the patentee’s standing to challenge this, raising rule-of-law concerns and damaging the investment environment.  In 2022, the government also raised pharmaceutical distributors and manufacturer’s windfall tax from 28% to 40%, on top of the already existing claw-back system.  Frequent such changes in the taxation system create an uncertain business environment. 

Recurring hospital debt, which is financed from the central budget at the end of each calendar, year remains the most significant problem in the country’s healthcare system, resulting in delaying surgeries and other necessary treatments.  Hungary’s state-run hospitals estimated debts of almost USD 300 million by the end of 2023 and USD 221 million in 2022.  Observers have severely criticized Hungary’s healthcare system and noted the following significant shortfalls:  

  • Minimum 90 days wait time for planned surgeries and treatments with special focus on neurosurgery, cholecystectomy, gynecology, and tonsil surgery. The wait time for orthopedic surgeries with knee or hip replacement can be up to 24 months in public hospitals.
  • Underuse of diagnostic examinations such CT or MRI due to capacity and lack of personnel.
  • High ratio of death or serious impact caused by cardiovascular diseases, stroke, lung and colon cancer and chronic obstructive pulmonary disease.
  • Prevalence of type 2 diabetes and obesity for both adults and children.
  • Aging and significant lack of medical professionals: GPs, pediatricians, anesthesiologists, and nurses.

Hungary spends 4.2% of its national GDP on healthcare.  Most of it is spent on wages, financing hospital debts, and maintenance of hospitals and out-patient clinics; only one third is spent on purchasing innovative medical equipment.   Per capita health expenditure was EUR 1,500 in 2022 in Hungary while the EU average was EUR 3,400 in 2022.

Hungary is working to achieve a globally significant position in certain sectors where its infrastructure and know-how are strong, such as clinical trials of innovative drugs, the development of biopharmaceuticals, in-vitro diagnostics, animal biotechnology, molecular medicines, and the use of bioreactors.  The historically strong Hungarian pharmaceutical industry has an established knowledge base and skilled workforce, which has enabled the creation of a red biotech subsector (such as gene therapy, stem cell research, and genetic engineering) adept at developing therapeutics, unique in the CEE region and strong by international standards.  Key representatives of international biotech companies present in the market include Richter, Amgen, Omixon, Biogen, Servier, UD-Genomed, and Solvo Biotech.  Hungarian biotechnology companies have also expanded their presence into major European markets.  The government supports such expansion via the National Research, Development and Innovation Office, which regards biotechnology as a strategic area for development. Significant results have been achieved in nanotechnology, molecular chemistry, and biotechnology services.  Red biotechnology – also known as biopharmaceuticals – is a highly prosperous sector in Hungary and market players are seeking opportunities to intensify their activity in the international arena.  The Hungarian Biotech Association plays a key role in conducting biotech research.  Hungarian universities including Budapest Semmelweis Medical University and Medical Universities of Debrecen, Pecs, and Szeged have active working relationships with international biotech research companies.  Pharma companies conduct around 300 clinical trials in Hungary every year.  Oncology, Neurology, Gastroenterology, and Hematology account for most clinical trials. Innovative pharma companies invest over HUF 28 billion (USD 82 million) in clinical trials in Hungary annually with an approximate 17,000 patients involved.

Medical device and pharmaceutical importers have faced serious challenges obtaining approval for placement on insurance reimbursement lists, including significant delays of up to 24 months (a common challenge among Central and Eastern European countries).  If a product is not included in the reimbursement scheme or paid for by insurance companies, the market for the product is limited or an exception needs to be requested.  Such ‘exceptions’ are preceded by lengthy negotiations between the company and the National Health Insurance Fund (NEAK), often delaying patient treatment. The catalog of reimbursed operations, medical aids, and pharmaceuticals is reevaluated every six months by law.  Drug categorization takes place on a bi-monthly basis.  Drug price referencing is executed twice yearly by NEAK.

The public health center NNK was merged with the drug supervisory OGYEI in a new entity, the Pharmaceutical and Food Safety Authority (NNGYK) in August 2023.  The new authority is overseen by the Interior Ministry and is responsible for coordinating the pharmaceutical market.  Its portfolio focuses on issuing licenses for the domestic distribution and manufacture of medicines. The new authority also supervises places of manufacture, oversees clinical trials, and analyses side-effects related to the products.

Leading Sub-Sectors

Most medical equipment suppliers in Hungary are EU-based manufacturers (primarily German, Italian, and French). Major U.S. medical suppliers, such as GE Healthcare, Medtronic, Johnson & Johnson, Varian, and Becton Dickinson, also have direct representatives or subsidiaries in Hungary.  The most promising subsectors are biomedical devices, diagnostic equipment, post-surgery recovery, therapeutic products and systems, imaging technologies, and dental equipment/supplies.  Investments in new medical equipment within the healthcare sector are expected to increase as both public hospitals, out-patient clinics, and private healthcare services are expected to grow.  In recent years healthcare technology has become a priority sector for the Hungarian Government.   

The government is implementing the “Healthy Hungary” program for the 2019-2030 timeframe.  There are five program elements: the National Cancer Program, the National Cardiovascular Program, the National Locomotion Program, the National Mental Hygenic Program, and the National Pediatric Program.  The government allocated USD 30 million (HUF 10.2 billion) from the central budget to healthcare service providers to improve services and medical technology in public healthcare institutions in Budapest between 2021-2024.  The funding is aimed at improving basic healthcare service and outpatient services to reduce wait times for certain medical interventions. The funding will be distributed among in- and outpatient clinics and hospitals around Budapest. Areas to be covered are MedTech-related developments, digital healthcare, and refurbishment of healthcare facilities. MedTech includes diagnostic imaging, radiology, and emergency room equipment.

Hungary has not had a dedicated Ministry of Health for the past ten years and healthcare policy is managed only at the State Secretary level within the Ministry of Interior.  Hungary is planning to develop basic healthcare services even in the absence of EU funds, according to the State Secretary

Telemedicine also is also a priority for the sector. The role of e-health will help to meet Hungary’s need to expand healthcare infrastructure, while improving services and personnel conditions.

A 120% wage increase has been implemented for doctors and nurses between 2019-2023. Another pay rise for doctors will be implemented in March 2024.  The average base salary for medical doctors is HUF 2.2 million (USD 6000) monthly.  

The focus of the new healthcare culture has been shifting to preventative measures and promoting sports and a healthy lifestyle.  The life expectancy of Hungarians is one of the lowest in Europe at 74.3 years while the EU average is 80.6 years.

Opportunities

Hungary’s local legislation concerning medical devices complies with EU directives.  Foreign producers that wish to export medical devices to Hungary are recommended to establish a contract with a local importer, who can help the company fulfill regulations such as the CE mark or the Medical Device Directive (MDD), Declaration of Conformity, and translation of directions and manuals into the Hungarian language.  Medical devices and pharmaceuticals are subject to a customs duty and VAT of 27%.  The duty for medical technologies imported from the United States ranges between 0-7% according to a specific Harmonized Schedule (HS) code under Chapter 90.

Specific MedTech items including ventilators, medical pumps and tubes, syringes, ECGs, and ultrasound scanners can be imported free of any tariff as of March 2020.  The specific HS codes and listings of these items are available at: https://net.jogtar.hu/

Hungary has market opportunities in the fields of sophisticated health technologies and equipment, dental care equipment and many other types of equipment that increase efficiency and reduce occupancy rates in hospitals. Products with the best sales potential in Hungary include but are not limited to:

  • Electronic Medical Records (EMR) systems
  • Patient monitoring and diagnostic systems
  • Mini invasive surgery (MIS) and day surgery equipment
  • CT and MRI equipment
  • Video endoscopes
  • Digital image processing and picture archiving 
  • Any related device and technology that advances Health IT, eHealth development
  • Skin and Breast Cancer detection medical technologies  

Procurements are mostly executed through public tenders.  Tenders for healthcare public procurements are published in the Supplement to the Official Journal of the European Union (Ted Tenders). The EU’s revised Medical Device Regulation and in Vitro Diagnostic Device Regulation went into effect in May 2021 and in May 2022 respectively.  The In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) establishes a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices.

The IVDR replaced the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022 and introduced substantial changes in the sector. The Regulation aims to ensure a high level of protection of public health, patients and users and the smooth functioning of the internal market considering the high number of small and medium-sized enterprises (SMEs) active in this sector. European Commission.

Main Competitors

Hungary’s medical device manufacturing sector is skilled and has enjoyed an increasing trend toward manufacturing. The number of innovative start-up companies is significant for MedTech solutions. More than half of the Hungarian medical device market is dominated by imports from EU markets such as Germany, France, Italy, and the UK. The total imports of MedTech products reached USD 2.2 billion in 2021.  Direct imports from the United States accounted for USD 220 million in 2021.   High-quality and technically-sophisticated U.S. medical equipment has the best market potential in Hungary. 

U.S. Embassy - U.S. Commercial Service  
Csilla Viragos, Commercial Specialist  
Budapest, Hungary  
Tel:  +36 1 475 4250  
Email: csilla.viragos@trade.gov