Equipping hospitals and practices in Belgium
Under a 2019 law, every Belgian hospital belongs to a locoregional clinical network. Whoever is buying must answer the same two questions early on. Can the device be made available in Belgium under the national rules for medical devices, with the right languages on the label? And will it reach a hospital in Leuven or a practice in the Ardennes on time?
We're MediGear, a distributor of medical equipment, registered in England and Wales. We quote, document, and ship certified equipment for healthcare buyers in more than 80 countries. Behind each quote are verified makers who can supply the unit, along with a checklist of the points that matter for a Belgian site, set out so your clinical and procurement teams can use it. You can send a request from our buyers page without opening an account.
Who in Belgium asks us for quotes
These are the types of hospitals and other buyers we quote for, with examples:
- University hospitals such as UZ Leuven, UZ Gent, UZA in Edegem and CHU de Liège
- Public and non-profit hospitals in the locoregional clinical networks, such as CHU Saint-Pierre in Brussels
- Private groups and day hospitals, for example CHIREC in Brussels and Braine-l'Alleud
- Veterinary practices, which have their own royal decree for X-ray work
- Dental practices that take dento-maxillofacial radiographs
- Humanitarian suppliers such as MSF Supply, which equips medical aid organisations
- The Defence medical service, which runs the Military Hospital at Neder-Over-Heembeek
Each one works to its own process. A university hospital buying for a new wing may run a formal tender under the Law of 17 June 2016 on public procurement, and the quote then has to slot into that dossier. A vet in the Ardennes comparing X-ray generators wants a clear answer and a delivery date. We find out which of these you are before we start, because it changes what the quote has to show.
FAMHP, the 2020 law and the three languages
The Law of 22 December 2020 on medical devices gives effect to the EU Medical Devices Regulation in Belgium. It names the Federal Agency for Medicines and Health Products (FAMHP) as the competent authority. The 2020 medical devices bill also addresses language. Information supplied with a device in Belgium must be in Dutch, French and German. Where only healthcare professionals use a device, it may come in English, but the user can still ask for a national language.
The distribution of medical devices is handled separately. A 2013 law required a distributor making devices available in Belgium to register with FAMHP before starting, and a firm based outside the EU reaches the market through an importer established in the Union. So ask FAMHP whether the Belgian distribution rules still apply to your purchase before you sign. We are neither a Belgian importer nor a registered distributor, and we cannot give regulatory advice. Our quote states each unit's certification, so your team can check it against the rules that apply to you.
FANC and the rules for X-ray rooms
Radiation protection is federal in Belgium. The Federal Agency for Nuclear Control (FANC) works under the radiation protection law of 15 April 1994, the general regulation of 2001 and a royal decree of 13 February 2020 on medical exposures. FANC's technical regulation of 19 February 2020 sets acceptability criteria for equipment used in simple dental radiography. Separate FANC technical regulations set acceptability criteria for CT and for fluoroscopy equipment.
FANC-recognised bodies carry out physical control of installations, and the general regulation sorts facilities into classes with different obligations. The steps for your room depend on the class and the modality, so ask FANC or your recognised body what is needed before the unit arrives. If the order is a CT scanner, a C-arm or a cone-beam dental unit, raise it while the quote is still open. We'll send the technical data on request.
What to check before a unit is built for Belgium
These are the specification points Belgian buyers ask us to settle with the maker most often:
- Mains supply. EU product rules define mains as 230 V at 50 Hz, but confirm the socket type with your technical department. Equipment built for 110 V or 60 Hz may require a separate factory build, which takes longer than fitting an adaptor.
- FANC acceptability. Medical X-ray equipment in use has to meet FANC's acceptability criteria. Ask for the unit's test data and service manual early.
- Consumables for life. Probes, electrodes, filters and cartridges should stay available for as long as you run the unit. We confirm compatibility and which spare parts and consumables you can reorder from us.
- eHealth links. The federal eHealth platform carries secure data exchange between care providers. For diagnostic imaging, your IT team should settle DICOM and HL7 settings before the unit joins the hospital network.
Where a detail is unclear, we raise it with the maker before quoting. It is much easier to settle a socket or software question now than on installation day.
Papers that travel with Belgian orders
When equipment comes from outside the EU, Belgian Customs works from the declaration and the documents behind it, so every order ships with:
- A commercial invoice and a packing list itemised by crate
- Proof of origin for the goods
- HS code classification line by line
- CE certificates alongside the maker's declaration of conformity
- Labels and instructions in the languages the Belgian rules require
Timber gets checked as well. Wooden crates and pallets coming from outside the EU fall under the EU plant health regime, which requires ISPM 15 treatment and marking. In Belgium, plant protection rules are set by the federal public health department, and AFSCA checks them in the field. We ask for treated, clearly marked crates from the outset whenever medical and precision equipment is packed in wood. Wood that fails the check can be destroyed, sent back or specially treated.
Ordering and shipping into Belgium
- Share the requirement. Give the model, specification and quantity, and name the hospital or practice, through the RFQ form or by email.
- Review a documented quote. You'll see the product, lead time, certification and the Antwerp-Bruges or Liège route, usually within 48 hours for catalogue items.
- Sign it off in writing. No order exists until you have confirmed it in writing.
- Sea or air into Belgium. Sea freight into the Port of Antwerp-Bruges, or air freight through Liège Airport (open 24/7 with customs on site) or Brussels Airport for smaller or urgent items.
Delivery is to the port or airport you nominate, and the onward leg is yours. For goods from outside the EU, your customs agent or representative lodges the import declaration electronically with Belgian Customs and you arrange clearance and transport to site. A unit shipped from a factory elsewhere in the EU crosses no customs border, so tell us where your stock is likely to come from.
One unit, a new wing or a tender
You don't need to order in bulk, and most catalogue lines can be quoted as a single unit, for example, one patient monitor or one autoclave for a practice. We also quote multi-line requests for new wings, day hospitals and lab builds, including public tenders; see government tender for that work. On a lab build, one quote can cover the full list, and a laboratory equipment supplier can send us its schedule in the same way. Theatre teams can look at Surgical and Therapeutic Equipment, and our refurbished range covers pre-owned units. A refurbished X-ray unit still has to meet FANC's acceptability criteria once it is in use.
Disclaimer
Everything on this page is general information for Belgian buyers. It makes no offer to supply and gives no legal, regulatory or customs advice. Quotes depend on what makers can supply, and an order only becomes firm when both parties have agreed it in writing. Whether a device can be made available in Belgium depends on its CE status, intended use and the language rules of the 2020 law, and X-ray equipment is subject to FANC's separate radiation rules. You remain responsible for import clearance and for the regulatory status of what you buy. We do not act as an importer or registered distributor in Belgium.
Is a replacement on your list?
Email the model number, or a data sheet or photo of the old unit, with the name of your hospital or practice in Belgium and any medical consumables to add. The quote covers CE status, the three label languages and freight into Antwerp-Bruges or Liège.
Frequently Asked Questions
No. Whether you work in health care in Brussels, Flanders or Wallonia, there is nothing to register for. Email connect@medigear.uk or complete the RFQ form on the buyers page with the model or specification. We quote for university and general hospitals, private groups, day hospitals, dental and veterinary practices, humanitarian suppliers and laboratory equipment suppliers.
Information supplied with a device in Belgium must be in Dutch, French and German. Devices used only by healthcare professionals may be supplied in English, but the user can still request a national language. The same rules apply whether the device is made in Belgium or abroad. We check what each maker provides.
A 2013 law required a distributor making devices available in Belgium to register with FAMHP, and a firm based outside the EU reaches the market through an importer established in the Union. Under EU regulations, medical device distributors and importers each have their own checks, so ask FAMHP or an adviser about your purchase.
FANC's technical regulations set acceptability criteria for medical X-ray equipment, with separate texts for dental radiography, CT and fluoroscopy. You can send us an offer from X-ray systems suppliers in Belgium, and we will quote the same specification. Recognised bodies carry out the physical control of installations. Ask FANC or your recognised body about your room before you order.
The Port of Antwerp-Bruges handles sea freight, and air freight goes into Liège Airport or Brussels Airport. We deliver to whichever of these you nominate. From there, clearance and the final leg to your hospital or practice are your responsibility.
That falls to you, usually through a customs agent or representative who lodges the declaration with Belgian Customs. We provide the commercial invoice, packing list, proof of origin, HS codes and the CE documents, so the declaration has what it needs.
No, one unit is fine on most catalogue lines. If a maker sets a minimum order quantity, we'll tell you right away. Tell us about the site too, such as a village practice with no loading bay, and we will ask for suitable packing.
That depends on the maker's stock, whether the unit is new or refurbished, where it ships from, and whether it travels by sea, air, or road from within the EU. Each quote gives the lead time and route, and we send updates by email from dispatch until it arrives.