Buy Medical Equipment in Hungary

KTR registration for Hungarian healthcare tenders

Since 1 February 2025, the winner of a device tender run by a state health institution must register itself and its products in OKFŐ's KTR database before signing. So for medical equipment companies bidding on Hungarian healthcare tenders, the paperwork behind a quote matters from the start. Any X-ray order from Hungary for a new unit carries a second deadline: the unit must pass its NNGYK acceptance test before its first patient and no later than 90 days after installation.

We're MediGear, a distributor of certified medical equipment for healthcare buyers in more than 80 countries, and we're registered in England and Wales. We quote, document and ship items across our catalogue, from monitors to laboratory systems. Send the model or the clinical need. We look for verified manufacturers who can supply it with Hungarian documents, and then we check the points below. Your engineers and buying staff get a quote they can work from, and our buyers page takes the request with no account.

Clinical centres, state hospitals and Medicare

Across public and private healthcare in Hungary, requests come from four university clinical centres and well beyond:

• Semmelweis University in Budapest, with nearly forty patient-care units
• The clinical centres of the universities of Debrecen, Szeged and Pécs
• State hospitals under OKFŐ, which coordinates a national CT and MR replacement programme
• Private networks such as Medicare, formerly Medicover, whose services include diagnostic imaging and endoscopy
• Dental practices with intraoral X-ray units
• Veterinary practices, which fall under the same radiation decree
• Companies on the national NOR register

KEF is the central buyer for state health institutions, which must use its system, and OKFŐ signs off on what they plan to buy. Tenders run on EKR, the electronic public procurement system, and bidders must register there first. A private clinic buying new diagnostic equipment, such as one ultrasound unit, wants a clear quote and a date. We'll follow whichever route you are on. If you are comparing quotes from imaging companies in Hungary, ours sets out the documents line by line.

NNGYK, the 2009 decree and Hungarian labels

NNGYK, the national public health and pharmacy centre, is the device authority. It works under Decree 4/2009 on medical devices, which was brought into line with the MDR. The label and instructions must reach the end user in Hungarian. A distributor based in Hungary must notify NNGYK before it starts to sell a device. The notice includes the Hungarian instructions, the declaration of conformity, and, for class I devices, the certificate.

A Hungarian distributor, including one that wants to expand distribution in Hungary, goes on the national NOR register, not EUDAMED, and must report any change within 90 days. The UK is outside the EU, so who acts as the importer when a hospital buys directly from us is for the hospital and its advisers to determine. We act as neither a Hungarian importer nor a distributor, and we do not give regulatory advice. Your team gets the certificate list with every quote.

OAH licensing and NNGYK acceptance tests

Radiation safety is the job of the OAH, the national atomic energy office. It works under the Atomic Energy Act of 1996 and Decree 2/2022. The licence holder names a radiation protection officer in writing, and training certificates are valid for five years.

A 2018 health decree sets the tests: NNGYK runs the acceptance test before first clinical use, no later than 90 days after installation. A status test then follows every two years. At the same time, dental units for images inside the mouth, ward and mobile units and bone density scanners are tested every four years, and any unit is tested again after work that affects how it runs. Only new X-ray machines get an acceptance test, and a used unit put back into service gets a status test instead. The licence holder also runs daily, weekly and monthly checks.

Annex 13 inspections and other details

Here is what we settle with the maker before quoting:

• Power. For a 230 V, 50 Hz supply and type C or F sockets, a unit built for 110 V or 60 Hz needs a different factory build, so we check the rating first.
• Safety checks. Bodies approved by NNGYK inspect the devices in Annex 13. Interventional X-ray, ventilators and defibrillators are inspected each year; monitors and infusion pumps every two years; and ultrasound every three. A used device gets its first inspection when it is commissioned.
• Supplies. Wear items such as probes and filters need replacing, so we can include spare parts and consumables in the first order.
• EESZT links. The EESZT platform connects providers' systems for e-prescriptions, referrals and records, so check HL7 support with your IT team, and DICOM for imaging equipment.

We settle open points with the maker in writing first, because the KTR entry and the inspection records both depend on exact product data.

eVÁM AIS and NÉBIH wood checks

Since 1 December 2023, imports can only be declared in eVÁM AIS, the system run by NAV, Hungary's customs authority. You can use a customs representative based in Hungary. Every consignment carries:

• Invoice and packing list, matched to the KTR product entries
• Proof of origin for the consignment
• HS codes, one per product line
• The declaration of conformity and, above class I, the certificate
• Hungarian instructions for use, with an English copy for the NNGYK notice

Wood over 6 mm thick in packing from outside the EU (Switzerland excepted) must meet ISPM 15, as NÉBIH's wood packaging leaflet sets out. A mark with any part missing is not accepted. Under EU rules, wood that fails is destroyed, sent back or treated, so we ask makers for crates with the full stamp.

Koper, Budapest and the last leg

1. Describe the unit. Send the model, quantity and site by RFQ form or email, and say whether the purchase is a state tender.
2. Check the documents. For catalogue items, the quote usually follows within 48 hours, and includes the product data a KTR entry needs.
3. Sign it off. Your written approval, by email or letter, starts the order with the maker.
4. Koper and the rail leg. Sea freight into Koper in Slovenia, then rail to Budapest, or air freight into Budapest for smaller items.

Delivery ends at the terminal or airport you choose. From there, your customs representative files the import declaration in eVÁM AIS, and you arrange the trip to the hospital.

A single unit, a ward refit or a used scanner

A clinic in Győr replacing one monitor, autoclave or medical imaging machine can order just that unit on most catalogue lines. Multi-line requests for wards and departments are quoted too, and if you are planning a Budapest health scheme, send the equipment list for a quote; see government tender for state tenders, and theatre teams can browse Sterilisation and Disinfection. For pre-owned units,,we offers our refurbished range, and Hungarian rules do not ban them, as far as wecan telld. A used Annex 13 device has its first safety inspection at commissioning, and a used X-ray unit needs an NNGYK status test before use.

Disclaimer

This page sets out general information for Hungarian buyers and nothing more. Use it as a starting point: it is not an offer to supply and should not be relied on for legal, regulatory or customs decisions. Quotes follow what makers can supply, and no order exists until both sides sign off in writing. Devices need user information in Hungarian and, for distributors based here, an NNGYK notice. X-ray units also fall under OAH radiation rules and NNGYK tests. Import clearance and the regulatory status of your purchase are your responsibility, and we are not a Hungarian importer or distributor.