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In Poland, X-ray units and rooms need a permit from the regional state sanitary inspector before start-up, and healthcare providers that import devices for their own use enter them in a URPL database. Our quotes for Poland set out the certificates, the Polish documents and freight to Gdańsk, Gdynia or Katowice.
In Poland, the Act of 7 April 2022 on medical devices applies alongside the EU regulation, and the President of URPL, the registration office, is the competent authority. A healthcare provider that brings devices into Poland for its own use has medical device obligations, including entering the devices in a URPL database. An X-ray unit also needs a permit from the regional state sanitary inspector before it is started up. A unit shipped from Great Britain is a non-EU import, so a medical equipment supply to Poland needs the paperwork for both steps.
Requests from healthcare buyers in more than 80 countries reach us at MediGear, a medical equipment distributor registered in England and Wales. We respond to each with a quote, documents, and freight for medical equipment and supplies. For Poland, we look for verified makers that can supply labels and instructions in Polish or English, and the Polish technical documents and X-ray permit file needed. Nothing reaches your engineers until the points below are settled with the maker. Requests reach us through the buyers page, and nobody needs an account.
NFZ, which pays for publicly financed care, has 16 regional branches, and we quote for health care in Poland at places such as:
A public hospital contract awarded by tender follows the Public Procurement Law of 2019. Procedures are published on the e-Zamówienia platform, which has included the Public Procurement Bulletin since January 2022. University hospitals also post their own tender pages and plans. Government programmes from February 2026 fund oncology centres at USK Wrocław (radiotherapy) and in Zielona Góra (nuclear medicine). A hospital outside that group, such as a municipal hospital or a nonpublic hospital, can name the model and site in its request. An exclusive distributor for one maker can do the same. Clinics that need a single unit of medical diagnostic equipment can start with just the model number.
A medical technologies distributor with a seat in Poland that makes available devices from another EU state joins URPL's distributor list within seven days of the first device. A healthcare provider or other business that brings a device into Poland for its own use instead enters it in URPL's database for importing entities. The entry carries the Basic UDI-DI, maker and importer details, label and instructions. For a unit bought from the UK, who holds the importer's role is a question for your own advisers.
Labels and instructions for professional devices may be in Polish or English, but anything meant for patients must be in Polish or use harmonised symbols. Devices for professional use may not be advertised to the public, and reprocessed single-use devices may not be made available in Poland. We do not sit on the distributor list or act as importer, and we give no regulatory advice, though each quote shows the unit's certificates.
The Atomic Law gives the National Atomic Energy Agency (PAA) charge of most radiation permits. Medical X-ray units and rooms, however, are permitted by the regional state sanitary inspector (PWIS). The permit file holds the room design with shielding calculations, a QA programme, the radiation protection inspector's opinion and Polish-language technical documents. X-ray diagnostic services also need PWIS consent, though intraoral dental and densitometry-only units are exempt.
Under sanitary guidance, the X-ray supplier should present its permit to start up the unit, or the hospital applies for start-up itself. Acceptance tests follow soon after installation, with the supplier's or installer's representatives taking part. Specialist tests then run at least once every 12 months for radiography, fluoroscopy, CT, and mammography, with basic tests monthly or every six months, and daily for mammography. Under Polish X-ray rules, a new unit owner needs its own permit.
Four answers we need from the maker before quoting:
Points still open go to the maker in writing before the quote, because the permit file names the exact unit, including its production year.
KAS, the National Revenue Administration, runs customs. Declarations for release for free circulation go through the PUESC services and AIS/IMPORT PLUS, and EORI numbers are issued there too. The paperwork we prepare for a Polish order:
Wood packaging imported into the EU, including Poland, must carry the ISPM 15 mark, as PIORiN, the plant health inspectorate, sets out. Border plant-health units check it, and customs officers may too. Wood that fails can be refused, sent back outside the EU, treated or destroyed, so we ask makers for heat-treated, stamped crates.
Once the goods reach the port or airport you choose, your agent files the customs declaration on PUESC, and the last leg to site is yours. Katowice Airport handled 28,356 tonnes of cargo in the first half of 2026.
Dental practices in Poznań and elsewhere can order a single intraoral unit, since most catalogue lines, X-ray equipment included, are quoted per unit. For tendered projects, see private tender, and physiotherapy teams can browse Physiotherapy and Wellness Equipment. We found no Polish ban on used or refurbished capital equipment, so our refurbished range can serve Poland, including refurbished medical imaging equipment. The same rules apply as for a new medical device: EU conformity on first placing in the EU, URPL data entry for a provider's own imports, and for X-ray, a PWIS permit and acceptance tests. Reprocessed single-use devices are banned.
The notes on this page are general and meant for planning by Polish buyers. They do not form an offer to supply and are not legal, regulatory or customs advice. The maker's stock decides what can be quoted, and no order exists until both sides confirm it in writing. Devices need Polish or English labels, with patient information in Polish or harmonised symbols, and X-ray units need a PWIS permit and acceptance tests. Your agent and installer handle clearance, start-up and the regulatory side, since we are not a Polish importer or distributor.
Sanitary inspectors expect an X-ray supplier to show its start-up permit, or the hospital applies itself, and the file needs Polish technical documents. Tell us the model and site, and the quote will set out the certificates, documents and route.
Yes. Any Polish hospital, such as UCK WUM in Warsaw, can send a model number or specifications via an RFQ form or email, and we reply in the same way. We quote for university and private hospitals, dental clinics, military units and Polish distributors.
Yes, if you bring the device into Poland for your own use. Healthcare providers and other businesses that bring in a device for their own use enter its data in URPL's database. Distributors with a seat in Poland that make available devices from another EU state join URPL's distributor list within seven days instead.
Yes, for devices meant for professional users: labels and instructions may be in Polish or English. Anything meant for patients must be in Polish or use harmonised symbols, and devices for lay users need Polish texts throughout.
The regional state sanitary inspector (PWIS) permits medical X-ray units and rooms. PAA handles most other radiation permits, and military units have their own issuer. The file includes shielding figures, a QA programme and Polish technical documents. Diagnostic X-ray services also need PWIS consent.
Acceptance tests come soon after installation, and after any repair that may affect image quality, with the supplier's or installer's representatives taking part. Specialist tests then run at least every 12 months for radiography, fluoroscopy, CT, and mammography, and basic tests monthly or every six months.
Through KAS's PUESC services, where the importer or its agent lodges the declaration for release for free circulation in AIS/IMPORT PLUS. EORI numbers are also issued through PUESC. Our papers for medical and surgical equipment cover the invoice, the waybill, the HS codes and the CE file.
Yes. Most catalogue lines are quoted per unit, and our first reply notes any minimum order from the manufacturer. Intraoral dental units need a PWIS permit but no separate consent for X-ray services and no radiation protection inspector, as the quote says.
Usually the X-ray file: the start-up permit, the Polish technical documents and the acceptance test with the installer. URPL data entry for your own imports and wood without the ISPM 15 mark can also hold things up, and the quote gives the lead time and route.