This is a best prospect industry sector for this country. Includes a market overview and trade data.
The EU’s revised Medical Device Regulation went into effect in May 2021. The revised In Vitro Diagnostic Device Regulation is set to go into effect in May 2022 (although an extension is being sought on the grounds that the European Union has not named a sufficient number of notified bodies to meet the demand for certifications caused by this regulation). In addition, restrictions put into place due to the COVID-19 pandemic have prevented many audits from taking place to certify device requirements under the Medical Device Regulation. The European Commission has published an official notice allowing notified bodies to conduct initial audits of medical device quality management systems virtually, which includes audits of manufacturers’ suppliers and subcontractors to verify their manufacturing and other processes, but this applies to the Medical Device Regulation and not the In Vitro Diagnostic Device Regulation.
The Hungarian medical technology sector employs 13,000 people directly and including suppliers the total number of employees in the sector is approximately 30,000. The Hungarian medical technology industry is a relatively small but concentrated sector with 980 manufacturers comprising 4.9% of Hungarian exports. 85% of exports go to EU countries. 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 strong academic 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 Billion in 2019 and consists mainly of electro-medical equipment, 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 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 190 Million in 2019. 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 and neurosurgery.
- Underuse of diagnostic examinations such CT or MRI.
- High ratio of death or serious impact caused by cardiovascular diseases and stroke.
- Aging and lack of certain medical professionals: GPs, pediatricians, anesthesiologists, and nurses.
Hungary spends 9.9% of its national GDP on healthcare according to Eurostat. Most of it is spent on wages and maintenance of hospitals and out-patient clinics and only a small portion 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 is 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 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, Solvo Biotechnology, etc. Hungarian biotechnology companies have also expanded their presence into major European markets. Expansion is supported by the Government of Hungary since the National Research, Development and Innovation Office 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 led by the Budapest Medical University (SOTE) and Medical Universities of Debrecen, Pecs and Szeged have active working relationships with international biotech research companies listed above.
Medical device and pharmaceutical importers may face challenges obtaining approval for placement on insurance reimbursement lists, including significant delays (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. The catalog of reimbursed operations, medical aids and pharmaceuticals is reevaluated every six months. Drug categorization takes place on a bi-monthly basis. Drug price referencing is executed twice yearly by the National Health Insurance Fund.
Economic growth and an increase in health spending resulted in a strong demand for medical device imports in 2020. Imports from the U.S. were USD 35.4 Million in 2020 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, and Becton Dickinson also have direct representations 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.
Budapest healthcare service providers will receive HUF 10,2 Billion (USD 34 Million) funding 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 in the 23 districts of Budapest. Areas to be covered will be 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 will receive between HUF 80 Million and 1,500 Million funding (USD 267,000 and 5 Million). Procurements will be 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.
As a member of the EU, 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 highly 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 systems
- Mini invasive surgery (MIS) and day surgery equipment
- Ambulance cars and related equipment
- CT and MRI equipment
- Video endoscopes
- Digital image processing and picture archiving
- Any related device and technology that advances Health IT, eHealth development.
Tenders for healthcare public procurements are published in the Supplement to the Official Journal of the European Union Ted Tenders
Hungary’s medical device manufacturing sector is skilled yet remains relatively small. Thus, more than 70% of the Hungarian medical device market is dominated by imports from European Union 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
Tel: +36 (30) 940-4039