Buy Medical Equipment in Bulgaria

Public money and the drug agency's list

Public money in Bulgaria comes with a string attached. The health insurance fund, state funds, and hospitals owned by the state or a municipality cannot pay for a medical device missing from the Bulgarian Drug Agency's list. So a public buyer's first check is the list, and the second is the route: a container through Varna, or a lorry over the land border with Romania.

We're MediGear. Quoting, documenting,g and shipping certified equipment is our job as a medical equipment distributor registered in England and Wales, and we do it for healthcare buyers in more than 80 countries. Name the model or the clinical need, and we find verified makers who can supply it. We then check the points a site in Bulgaria will raise and send a quote your clinical and buying staff can use. To send a request, go to our buyers page. Nono accounts are required.

Who we quote for in Bulgaria

These are the kinds of buyers we prepare quotes for in Bulgaria:

• University hospitals in Sofia, such as Alexandrovska, Sveta Ekaterina and Pirogov
• Regional university hospitals, among them Sveta Marina in Varna and Sveti Georgi in Plovdiv
• The Military Medical Academy and its hospitals in Plovdiv, Varna, Sliven and Pleven
• Outpatient medical and diagnostic centres with health fund contracts, and specialist heart clinics
• Private hospitals, for example Eurohospital in Plovdiv
• Dental and veterinary practices with their own X-ray machines
• A wholesaler or medical technologies distributor that holds the drug agency's authorisation to trade in devices

Each part of the health system in Bulgaria buys in its own way. The Bulgarian Ministry of Health is the sector's central buyer, so check whether your purchase goes through the hospital or the ministry. Public tenders for medical devices and consumables run through CAIS EOP, the national online tender system. A dental practice in Burgas that needs one new unit wants a clear quote and a date. We ask how you buy before we quote, because the paperwork follows.

The Bulgarian Drug Agency and its list

Bulgaria applies the EU Medical Devices Regulation alongside its own Medical Devices Act, and the Bulgarian Drug Agency (BDA) watches the market and licenses wholesalers. The act calls for instructions for use in Bulgarian, and the BDA posts its register of authorised wholesalers of medical devices online. A separate BDA database holds the list that decides whether public funds can pay for a device.

For a model not yet on the list, the maker, a person it names, or a wholesaler can apply to add it. Check the point before a public order is placed, because a device outside the list cannot be paid for with health fund or state money. Under the MDR, the importer must also be based in the EU and registered in EUDAMED. A Bulgarian hospital that buys directly from the UK should ask its own advisers who hold that role. We are not a wholesaler or importer in Bulgaria and cannot advise on regulatory questions. Our quote lists each unit's certificates, so your team can check them.

Nuclear Regulatory Agency licences for X-ray

Ionising radiation falls under the Safe Use of Nuclear Energy Act, and the Nuclear Regulatory Agency (NRA) issues the approvals. Medical and veterinary X-ray needs a licence for use, valid for up to ten years, and building, fitting and pre-testing an X-ray room needs a permit. The NRA's guidance on licences and permits also lists an import permit for radiation sources. Dental units for images inside the mouth only need a notice.

For diagnostic radiology in Bulgaria, a Ministry of Health rule from 2018 sets out the tests. The installer runs a first acceptance test, followed by a commissioning test. Still, routine quality checks must be done by testers on the ministry's register, never by the supplier or service firm. Servicing is due at the manufacturer's interval and at least every six months. Engineers who install or service units in Bulgaria need their own NRA registration, so ask early.

Technical points for hospitals in Bulgaria

Getting the specification right at the start of medical equipment supply saves time later. These are the checks we run with the maker for sites in Bulgaria:

• 230 V and 50 Hz. That is the EU's definition of mains, and Bulgarian sockets take type C and F plugs. A 110 V or 60 Hz design may need its own factory build rather than an adaptor.
• Delivery papers. X-ray units must arrive with the maker's technical file, operating papers in Bulgarian, the declaration of conformity and calibration records for any built-in dose meter.
• Parts and software. An X-ray unit may not be put in if the maker does not supply spare parts or software support. Our quote notes which spare parts and consumables fit and can be reordered later.
• Records. Check DICOM and HL7 settings, and any link to the National Health Information System, with your IT team.

Clear up unclear points with the maker first. A question asked now takes far less time than a unit that fails its first on-site test.

Paperwork for shipping medical equipment to Bulgaria

The National Customs Agency clears goods from outside the EU on the declaration and its papers, and every order carries:

• Commercial invoice with a packing list
• A certificate of origin naming the country of manufacture
• The HS code against each invoice line
• Copies of the CE certificates and the declaration of conformity
• Instructions for use and operating papers in Bulgarian

Wooden crates need attention as well. Wood packaging from outside the EU, including the UK, must be ISPM 15 treated and marked under EU plant health rules; in Bulgaria, the Food Safety Agency is the plant protection body. Wood that fails a check can be destroyed, sent back or treated, which is why we ask for treated, marked crates on heavy units from the start.

How an order travels to Varna or the land border

1. Tell us the details. The RFQ form or an email with the model, specification, quantity and the hospital or centre is all it takes.
2. Go through the quote. The product, lead time, certification, and route are all included, usually within 48 hours for catalogue items.
3. Confirm it in writing. We treat nothing as ordered until we receive your written confirmation.
4. Freight by sea or air. Sea freight into Varna, where the Varna-West terminal handles containers with links to rail and road, or air freight for smaller or urgent items.

The import becomes yours at the port or airport you nominate. Your customs representative lodges the declaration with the National Customs Agency, and you arrange the last leg to site. Checks on people at the land border with Romania were lifted in January 2025, and goods from an EU factory cross no customs border.

Small orders, clinic projects and used imaging

A single monitor for a children's hospital or an autoclave for a diagnostic centre is as welcome as a large order, since most catalogue lines can be quoted one at a time. We also quote multi-line requests for a new ward or clinic, whatever types of medical equipment it needs; see clinic setup for that kind of work, and imaging teams can start with Medical Diagnostic Equipment—our refurbished range covers pre-owned units, with conditions here. In addition to the paperwork for new X-ray equipment, a used X-ray unit needs its full service history and a five-year spare parts declaration, and CT and angiography units must be factory-new or factory-refurbished.

Disclaimer

This page is a general guide for buyers in Bulgaria. It is neither an offer to supply nor legal, regulatory or customs advice. Quotes depend on what makers can supply, and an order becomes firm only when both sides agree in writing. Whether a device can be supplied depends on its CE status and intended use; public payment depends on the Bulgarian Drug Agency's list; and X-ray equipment requires Nuclear Regulatory Agency approval. Clearing the goods and confirming the regulatory position are your tasks. We do not act as a Bulgarian wholesaler or importer.