A licence number before the X-ray leaves
In Finland, a radiation source that needs a licence may be handed over only to an undertaking that holds the right STUK safety licence. The party handing it over must ensure this. The customs declaration for an imported X-ray unit must also include the licence number. From 1 January 2027, a breach of the handover rule falls under the penalty section of the Radiation Act, so expect to share your licence details with the order.
We're MediGear, a medical equipment distributor registered in England and Wales, quoting, documenting and shipping certified equipment. Our healthcare buyers are spread across more than 80 countries. Send a model number or describe the need, and we match verified makers to it. A laboratory can send us its list of clinical diagnostics. Then we check the language, licence and testing points below before the quote reaches your clinical engineers and procurement team. Our buyers page handles requests, and there is no account to open.
Wellbeing counties, HUS and private groups
In the Finnish healthcare system, 21 wellbeing services counties have run public care since 2023. Helsinki health care sits outside them: the city organises its own services, while the HUS Group handles demanding specialised medical care. We quote for all of them alongside private providers:
- HUS Helsinki University Hospital, which covers all medical and dental specialities
- Tays in Tampere, Tyks in Turku, OYS in Oulu and KYS in Kuopio
- Wellbeing services counties buying for regional hospitals and for central ones such as Vaasa Central Hospital
- Private groups such as Terveystalo, with more than 200 locations, Pihlajalinna and Mehiläinen, which offer imaging services
- Dental and veterinary practices, which need STUK safety licences for X-ray
- ÅHS, the health service of Åland in Mariehamn
- Finnish distributors registered with Fimea, and laboratory equipment suppliers sourcing for their customers
Public purchasing follows the Act on Public Procurement and Concession Contracts, reformed with effect from 18 June 2026. Since 1 October 2026, contracts must be split into lots, or the choice not to split must be justified. Joint purchasing runs through Hansel, the state's central buyer, and regional companies such as Tuomi Logistiikka, with notices on HILMA. A private clinic replacing one ultrasound unit needs a clear quote, so mention which healthcare procurement route you're on.
Fimea, section 5 and two national languages
Fimea, the Finnish Medicines Agency, is the device authority, and the Medical Devices Act 719/2021 supplements the EU regulation. Distributors that supply professional users in Finland register with Fimea, although it has said it will not ask for device notifications until further notice. Single-use devices may not be reprocessed or reused in Finland.
Section 5 sets the language. Information the MDR requires may be in Finnish, Swedish or English, but anything needed for safe use must be in Finnish and Swedish. Devices for patients or consumers also need both languages in the instructions. An importer must be based in the EU, and who holds that role when a hospital buys from the UK is for the hospital and its own advisers to settle. Since we are not an importer or distributor in Finland, regulatory advice should come from your own advisers. Each quote lists the unit's certificates.
STUK safety licences and S/5/2019 tests
STUK, the Radiation and Nuclear Safety Authority, licenses the use of radiation under the Radiation Act, and use includes trade, installation, maintenance, import and possession. Medical X-ray has no notification route, so every hospital, clinic or practice running one needs a safety licence. A further X-ray unit is notified to STUK within two weeks of going into service. If it differs from those already licensed or needs new shielding, a licence amendment comes first.
STUK's regulation S/5/2019 requires an acceptance inspection before commissioning. Compliance with the in-service criteria is then checked at intervals of no more than 24 months (12 for CT and fixed interventional fluoroscopy), and veterinary units may go to 36 months; intraoral units are not covered by this check. Image-quality tests run every 6 or 12 months by modality. The appliance's lifetime defect records travel with it, and installers must hold their own STUK licence.
Before the maker builds a Finnish unit
These are the details we confirm in writing:
- Mains. A Finnish socket takes a type C or F plug on 230 V and 50 Hz, so a unit made for 110 V or 60 Hz has to be built differently.
- Handover condition. Whoever installs or services a device must hand it over in the condition the maker intended, servicing it first if needed. This applies to used medical equipment too, so ask for the service manual early.
- Winter stock. Icebreaker restrictions can limit which ships call in winter, so keep probes, filters and cartridges on the shelf, and our spare parts and consumables range covers reorders.
- Kanta links. Kela's Kanta Services carry national health records, so check DICOM, HL7 and any Kanta link with your IT team.
Whatever is still open goes to the maker in writing before we quote, since a licence amendment or a missing Swedish text can delay a quote.
Tulli, EORI and stamped crates
The importer, or a representative it authorises such as a forwarding agency, files the import declaration through Tulli's Customs Clearance Service, and an EORI number is needed first. For an X-ray unit, the declaration states the safety licence number. Our file for each order contains:
- Commercial invoices for the declaration
- Origin documents, where they apply
- HS codes for each line
- Declaration of conformity and any notified body certificates
- Safety information in Finnish and Swedish
ISPM 15 applies to all wood packaging that enters the EU. The Finnish Food Authority and Finnish Customs supervise it, and the authority's page on wood packaging import controls sets out its intensified controls on listed goods from China, Belarus and India. We ask makers for treated, marked crates.
Ordering, harbours and the ice season
- Write to us. Use the RFQ form or email with the model, quantity and site, and add your STUK licence number for X-ray.
- Check the quote. It names the Finnish port and sailing route, as well as the product, lead time and certification, usually within 48 hours for catalogue items.
- Approve by letter or email. The order goes to the maker once we receive those approvals.
- Harbours and air. Sea freight into Helsinki's Vuosaari harbour, HaminaKotka or Rauma, or air freight via Helsinki Airport for smaller items.
In winter, the Transport Infrastructure Agency sets the minimum ice class and size a ship needs for icebreaker help, which can affect sailings. Once the goods reach the port you nominate, your representative files the import declaration, and you arrange the last leg. Åland has its own customs rules for trade with the mainland, so tell us if a unit is going there.
One unit, a new hospital or pre-owned imaging
Most catalogue lines are quoted per unit, so one monitor or autoclave for a health centre is a normal request. Health care in Helsinki is gaining a new hospital, as HUS and the city build the Laakso Joint Hospital in phases to 2030, with the first phase due to begin operations in 2027. We also quote multi-line requests for new hospitals and wards; see hospital setup for larger projects, and women's and children's units can browse Women, Children and Neonatal. We found no national ban on importing refurbished medical equipment, and pre-owned units are in our refurbished range. A used X-ray unit still goes only to a licence holder, with its lifetime defect records, and it needs an acceptance inspection before use.
Disclaimer
For buyers in Finland, this page is a general guide. It does not make an offer to supply, and nobody should treat it as legal, regulatory or customs advice. Makers' stock limits what we can quote, and an order is settled only in writing on both sides. Devices must meet the language rules of section 5, and X-ray equipment can be handed over only to a STUK safety licence holder. You carry the import clearance and the regulatory checks, and we are not a Finnish importer or distributor.
Is your STUK licence to hand?
X-ray apparatus can be handed over only to a holder of a STUK safety licence, and the customs declaration must give that licence number. Send your licence details with the model number, and the quote will set out the CE file and the sailing.
Frequently Asked Questions
No. Requests can come through the RFQ form on the buyers page or by email to connect@medigear.uk; we only need a model number or specification. We quote for wellbeing services counties, such as Varha, which organises public health care in Turku, and for university hospitals, private groups, dental and veterinary practices and distributors.
Information the MDR requires may be in Finnish, Swedish or English, but anything needed for safe use must be in Finnish and Swedish. For devices used by patients or consumers, the instructions must also be in both languages.
Distributors that supply health and care providers and other professional users in Finland register with Fimea, although it has paused device notifications until further notice. The importer must be established in the EU, so a hospital ordering from outside it should check its own position first.
Only appliances of 30 kV or less with a very low dose rate are exempt, so medical and dental X-ray need a STUK safety licence. A further unit is notified to STUK within two weeks of going into service, or needs a licence amendment first if it differs.
Sea freight goes into Helsinki's Vuosaari harbour, HaminaKotka or Rauma, and smaller items can fly into Helsinki Airport. In winter, icebreaker assistance depends on a ship's ice class. Our delivery ends at your chosen port, and the onward leg is yours.
The importer or its representative files it through Tulli's Customs Clearance Service, with commercial invoices and any origin documents, and needs an EORI number. For an X-ray unit, the declaration also gives the safety licence number.
Health centres and other medical practices can order a single unit on most catalogue lines, from medical diagnostic equipment to autoclaves, and we flag any minimum quantity the maker sets. For a long road leg in winter, such as one to Lapland, tell us, and we will request packing that can handle the cold.
As early as you can, since stock, the route, and the licence steps for X-ray set the lead time, and icebreaker restrictions can affect winter sailings. For regular medical equipment supplies in Finland, share your reorder dates so we can plan around the ice. We put the lead time and route in writing and email progress from dispatch.