Overview

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 will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022 and introduce 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

The Hungarian medical technology sector employs 13,000 people directly and including suppliers the total number of sector employees is 17,000.  The Hungarian medical technology industry is a relatively small but concentrated sector with 980 manufacturers comprising 4.9% of Hungarian exports.  85% of exports went to foreign markets in 2020.  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 innovations.  The Hungarian MedTech sector includes highly educated background, cutting edge research and development in university spinoffs with research areas in medical imaging, electric and biosensor devices, as well as lab diagnostics. 

Annual local production was valued at USD 1.2 billion in 2020 and consists mainly of electro-medical equipment, ventilators, blood pressure equipment, lab kits, surgical and dental supplies, apnea alarms, incubators, infusion pumps, mechanical medical supplies, maternity products, and specialized x-ray and IVD equipment.  Local production and imports generally complement each other. 

Recurring hospital debt which is financed from the central budget at the end of each calendar year remains the biggest problem in the country’s healthcare system resulting in postponing surgeries and other inevitable treatments.  Hungary’s state-run hospitals generated debt of almost USD 140 million in 2020 and USD 136 million in 2021.  Hungary’s healthcare system has been criticized in several fields calling for system-wide changes including:

• Minimum 90 days wait time for planned surgeries and treatment with special focus on orthopedics, neurosurgery, gynecology, and tonsil surgery.
• 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 and stroke.
• Aging and significant lack of medical professionals: GPs, pediatricians, anesthesiologists, and more importantly nurses.

Hungary spends 6.4% of its national GDP on healthcare according to Eurostat. Most of it is spent on wages, hospital debts and maintenance of hospitals and out-patient clinics; only one third is spent on purchasing innovative medical equipment.  

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 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 yet also strong by international comparison.  Key representatives of international biotech companies present in the market include Richter, Egis, Amgen, Omixon, Biogen, Servier, UD-Genomed, Solvo Biotech, etc.  Hungarian biotechnology companies have also expanded their presence into major European markets.  Expansion is supported by the Government 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 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.  Prominent Hungarian universities including Budapest Semmelweis Medical University and Medical Universities of Debrecen, Pecs and Szeged have active working relationships with international biotech research companies.  

Medical device and pharmaceutical importers have been facing 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 on the reimbursement scheme, paid 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), delaying patient treatment or resulting in occasional approval. 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 the NEAK.

Leading Sub-Sectors

Economic growth and an increase in health spending resulted in a strong demand for medical device imports in the past two years.  Imports from the U.S. amounted to USD 41 million in 2021. (Trade Stat Express)

The majority of 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 and 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.  Due to the ongoing pandemic, healthcare technology has become a priority sector for the Hungarian Government.   

The government allocated USD 34 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 60-200 day 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, refurbishment of healthcare facilities. MedTech includes diagnostic imaging, radiology and emergency room equipment. Digitalization and telemedicine, or telehealth, are also priorities for the sector. The role of e-health will help to meet Hungary’s need to expand the healthcare infrastructure, while improving services and personnel conditions.  Local district governments receive between USD 267,000 and USD 5 million (HUF 80 million and HUF 1.5 billion) in funding.  Procurements are executed through public tenders.

The focus of the new healthcare culture has been shifting to preventative measures and promoting sports and a healthy lifestyle, to extend the average age of Hungarians, which is currently one of the lowest in Europe at 74 years.

Opportunities

Hungary’s local legislation concerning medical devices complies with EU directives.  More information on national requirements can be found at the National Institute of Pharmacy and Nutrition.  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 according to a specific Harmonized Schedule (HS) code and is between 3-11%.

Hungary has market opportunities in the fields of sophisticated health technologies and equipment, dental care equipment and many other devices 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 Cancer detection medical technologies.

Tenders for healthcare public procurements are published in the Supplement to the Official Journal of the European Union (Ted Tenders).

Main Competitors

Hungary’s medical device manufacturing sector is skilled and has been on an increasing trend for manufacturing.  Roughly 60% of the Hungarian medical device market is dominated by imports from EU markets such as Germany, France, Italy, and the UK.  Direct imports from the United States account for about 9%.   High quality and technically sophisticated U.S. medical equipment has the best market potential in Hungary, especially equipment that increases efficiency and reduces occupancy rates in hospitals. 

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