Czech instructions and a registered importer
A Czech hospital generally may not use a medical device unless its instructions for use are in Czech, under section 39 of the Medical Devices Act. X-ray apparatus adds one more rule. Anyone importing or distributing a radiation generator must first register with the State Office for Nuclear Safety (SÚJB). Both points shape a quote long before a container is loaded in Hamburg.
We're MediGear, and for healthcare buyers in more than 80 countries, we act as a medical equipment distributor, quoting, documenting and shipping certified equipment and other medical technologies from a company registered in England and Wales. Give us the model or clinical need, and we look for verified manufacturers who can supply it with Czech documentation. A data sheet or brochure collected at medical equipment trade shows is enough to start with. Then we check the Czech manual, notification and SÚJB points below. Your clinical engineers and buying team get a quote they can act on, and our buyers page takes requests without an account.
Faculty hospitals, hospital companies and private groups
Requests from Czechia come from these buyers:
- Faculty hospitals run by the health ministry, such as VFN and Motol in Prague, FN Olomouc and FN Ostrava
- IKEM in Prague and other ministry institutes, such as Na Homolce Hospital
- Hospital companies such as Krajská zdravotní, with sites from Ústí nad Labem to Děčín
- Private groups such as AGEL and Penta Hospitals, and veterinary practices that register their X-ray units with SÚJB
- Dental practices, most of whose X-ray units need a registration rather than a licence
- FN Brno, which is preparing a contractor tender for a new PET/CT pavilion
- Medical device companies in the Czech Republic notified to SÚKL as distributors or servicing firms
A faculty hospital is a contracting authority under Act No. 134/2016 on public procurement. It publishes tenders on certified electronic tools and in the procurement bulletin. NEN, the state's free certified tool, is run under the regional development ministry (MMR). A private clinic replacing one ultrasound unit needs a clear quote, so tell us how you buy.
SÚKL, ISZP and the Czech manual
The State Institute for Drug Control (SÚKL) is the device authority, and Act No. 375/2022 on medical devices sits alongside the EU Medical Devices Regulation. Distributors and servicing firms must notify SÚKL through its ISZP information system before they start, unless they handle only class I devices. These notices have gone to ISZP rather than the older RZPRO register since March 2024.
The manufacturer must supply the instructions for use in Czech, while Czech, Slovak and English are all accepted for the declaration of conformity. The importer's details must appear on the device, its packaging or the instructions, because a delivery note does not count. Who holds the importer role when a hospital buys straight from the UK is for the hospital and its own advisers to settle. We are neither a Czech importer nor a notified distributor, and regulatory advice is outside our remit, though each quote lists the unit's certificates.
SÚJB licences, registration and stability tests
X-ray examinations, like all work with radiation sources, fall under the Atomic Act of 2016 and its decree on radiation protection. Diagnostic and interventional X-ray needs an SÚJB licence, as its page on licences in radiodiagnostics explains, and the same page puts plain radiography and intraoral dental units in veterinary practice under a registration. Most dental X-ray units and bone densitometers also need a registration. Installing, commissioning, acceptance and long-term stability testing, and servicing radiation sources are licensed activities in their own right, separate from the user's licence or registration, with some exceptions.
An acceptance test follows installation. Under the 2016 decree, long-term stability tests are then carried out every 12 months for significant diagnostic sources and every 36 months for simple ones. The licence application sets the scope and frequency of constancy tests. Check the current intervals with SÚJB, as the decree has been updated since. Registration to import a generator needs proof of professional competence and quarterly reports.
Plugs, BTK checks and records
These are the four points we check first:
- Plug type. The IEC lists type C plugs for Czechia, and EU product rules set mains at 230 V and 50 Hz. Ask your engineer to confirm the socket type on site, and flag any 110 V or 60 Hz design early.
- BTK checks. Safety-technical checks follow the maker's scope and interval, and electrical devices without one are checked at least every two years. Radiation tests do not replace them.
- Disposables. Reprocessing single-use devices is banned here, so plan your stock. Tell us whether you want disposables from the Czech Republic or from abroad. Spare parts and consumables can go on the same quote.
- EZKarta and records. The health ministry's EZKarta app shows patients selected results and documents. Ask your IT team to check DICOM and HL7 options before the unit joins the network.
Any remaining details go back to the maker in writing, because a missing manual can stop Czech medical equipment from being used even after it is installed.
The new import system and ÚKZÚZ crate checks
Czech customs moved to a modernised import system on 18 May 2026, with a new web client for import declarations. Each order ships with a file that includes:
- Invoice and packing list, with serial numbers listed
- Origin documents, if your declarant needs them
- The HS code for every unit and accessory
- Declaration of conformity: Czech, Slovak or English
- Instructions for use in Czech
Wood packaging from outside the EU must be ISPM 15 treated and marked, though no phytosanitary certificate is needed. ÚKZÚZ, the agriculture ministry's inspection body, answers the common questions on wood packaging imports. The check happens in the EU country where the goods first enter, such as Germany for a Hamburg routing, so we ask makers for heat-treated, stamped crates.
Hamburg by sea, a Czech terminal by rail
- Start with the model. Use the RFQ form or email with the model, quantity and site, and name your importer.
- Read it through. Expect it usually within 48 hours for catalogue items, with the Czech manual status, certification, lead time and the rail leg from Hamburg.
- Put it in writing. We order from the maker once we receive your written approval.
- By sea and rail. Sea freight into Hamburg and on by rail to a Czech terminal, or air freight into Václav Havel Airport Prague for smaller or urgent items.
Once the goods reach the terminal or airport you nominate, your declarant files the customs declaration electronically with Czech customs, and you arrange the last leg to site. From 1 November to 31 March, winter tyres are required when snow, ice or frost lies on the road or is expected, and lorries over 3.5 tonnes need them on the driven axles.
One unit, a new pavilion or a used X-ray unit
Most catalogue lines can be quoted as a single unit, so a clinic replacing one monitor, one autoclave or a single imaging plate and cassette can order just that. Multi-line work for new pavilions and wards is quoted too; see hospital setup for that kind of project. You will find instrumentation for laboratories under Lab, Pathology and Blood Bank. Pre-owned units come from our refurbished range, and we can't find any Czech law that bans them. A used unit still needs CE marking, Czech instructions, and safety checks; a used X-ray or computed tomography unit needs an SÚJB licence or registration for its new site, and the tests the decree sets after installation.
Disclaimer
Buyers in Czechia should read this page as general information only. We are not offering to supply anything through it, and you should seek legal, regulatory and customs advice elsewhere. Each quote is subject to the maker's availability, and nothing is ordered until both sides agree in writing. A device must carry CE marking and, as a rule, Czech instructions before a provider may use it, and X-ray equipment needs an SÚJB licence or registration. Clearance and your regulatory position remain with you, and we are not a Czech importer or notified distributor.
Need instructions in Czech?
Hospitals in the Czech Republic generally may not use a device without Czech instructions, so we check manuals first. Email a model number or data sheet, name the site, and we'll reply with the CE file, the manual languages and the rail route in.
Frequently Asked Questions
Email connect@medigear.uk with the model or specification, or fill out the RFQ form on the buyer's page; neither requires an account. We quote for publicly owned hospitals in the Czech Republic, private groups, dental and veterinary practices, laboratories and research sites, and distributors, and every reply comes by email.
Generally not. A provider may not use a device without instructions for use in Czech, except some class I or IIa devices that the maker supplies without them. The rule covers imports as well as devices made in Czechia. For the declaration of conformity, Czech, Slovak and English are all accepted.
Distributors and servicing firms notify SÚKL through ISZP before they start, unless they deal only in class I devices, and for higher classes the notice includes the device's Basic UDI-DI. Importers and manufacturers also register in EUDAMED, so both systems matter.
Diagnostic and interventional X-ray needs an SÚJB licence, while most dental X-ray, bone densitometers and plain or intraoral veterinary X-ray need a registration. Installing, testing and servicing are licensed activities too, and importing a generator needs its own registration, so check with SÚJB which applies to your room.
Large items, including electromedical imaging equipment, can go by sea into Hamburg and then by rail to a Czech terminal. In contrast, smaller or urgent items can fly into Václav Havel Airport Prague. We deliver to the terminal or airport you nominate, and your declarant handles the last leg from there.
Czech customs runs a modernised import system, live since 18 May 2026, with a web client for declarations. Your declarant uses it, and we provide the invoice, packing list, origin documents, HS codes and CE papers for each consignment of medical products and disposables.
Yes. Most catalogue lines are quoted per unit, whether you need one monitor or one piece of laboratory equipment, and any minimum order quantity set by a manufacturer is flagged at once. If the last leg is a long road haul in winter, please tell us, and we will ask for packing to suit.
The maker's stock, whether the unit is new or refurbished, the sea and rail legs and, for X-ray, the SÚJB steps. You will find the lead time and the rail route in the quote, and we send updates by email once it ships.