Buy Medical Equipment in Romania

An ANMDMR aviz before import

Anyone who wants to import, install, or service medical devices in Romania, or be a distributor in Romania, needs an operating permit (aviz) from ANMDMR. ANMDMR is the National Agency for Medicines and Medical Devices, and the aviz must be held by a person or firm based in Romania. Firms that work lawfully in another EU or EEA state are exempt, but that rule does not reach a UK firm. Since 17 August 2026, an importer also needs an EUDAMED importer number before it can get or change an import aviz. So a quote for Romania starts with the importer that holds the permit.

We are MediGear, a medical technologies distributor and marketplace registered in England and Wales, not a distributor in Romania. For healthcare buyers in more than 80 countries, we prepare the quote, export documents,s and freight booking. For Romania, we look for verified manufacturers of medical systems and devices that can provide labels and instructions in Romanian, and, for X-ray units, the technical file in Romanian as well. We clear up the points below before your engineers and buyers see a quote. The buyers page takes your request, and you do not need an account.

Emergency hospitals, institutes and private networks

We quote for hospitals in Romania, from public institutes to private networks, such as:

• The Fundeni Institute and emergency hospitals in Bucharest
• County emergency hospitals in Cluj-Napoca, Iasi and Timișoara
• The cancer institutes in Cluj-Napoca and Iasi
• Private networks such as MedLife and Regina Maria, and heart surgery teams
• Dental clinics with intraoral, panoramic or CBCT units
• County councils that buy for their hospitals
• Romanian importers that hold an ANMDMR aviz

The Ministry of Health publishes a list of hospitals in Romania, and those on it are among the hospitals we quote for. Tenders for Romanian public hospitals run under Law 98/2016 on SEAP, the national e-procurement system, and county councils run them to equip hospitals in their counties. CNAS runs social health insurance for healthcare in Romania. In Cluj, a new regional centre for cerebrovascular disease and neurosurgery, paid for through the recovery plan, was handed over on 29 August 2026 with imaging systems: MRI, CT and an angiograph. A private hospital in Iasi can start with the model number alone, as can any practice that needs one unit.

ANMDMR advice, Romanian labels and periodic checks

Title XX of Law 95/2006 sets the national rules alongside the EU regulation. Under 2020 norms, an ANMDMR operating permit covers import, distribution, and installation or maintenance. It lasts three years; the firm needs a person in charge of regulatory compliance, and you apply online. Users must have installation, upkeep and repair done by firms that hold an aviz, and they must keep their devices under periodic checks.

Romanian medical technology equipment must carry labels and instructions in Romanian, with English only by ANMDMR exception. That exception requires written agreement from health staffing, applies only in exceptional cases,s and lasts for a set time. Holding no Romanian aviz ourselves, we give no regulatory advice, but every quote names the certificates the unit carries.

CNCAN registration, authorised suppliers and yearly bulletins

X-ray and other radiological equipment fall to CNCAN under Law 111/1996 and a 2022 order on diagnostic and interventional X-ray. Every practice must be notified. Dental X-ray, general X-ray and fluoroscopy, mammography and bone density units need registration with CNCAN, while fixed CT and angiography need authorisation in phases. X-ray units must be bought from authorised suppliers, carry the CE mark and a notified-body certificate, and come with technical documents in Romanian.

Under CNCAN Order 155/2018, a supplier of X-ray units needs a supply authorisation and may sell only to buyers who prove they comply, and shipments to or from non-EU states need an import or export authorisation. We have not confirmed how the supply rule applies to a UK seller. Only firms authorised by CNCAN may install, repair and test the units. After each repair, and at least once a year, such a firm issues a test report, called a verification bulletin. ANMDMR also checks X-ray and MRI units every three years, or every two years once a unit is more than 15 years old.

230 V, Romanian documents and unit age

Before we quote, the manufacturer confirms four things:

• Mains and connectors. Romania uses 230 V at 50 Hz, and the IEC tables list type C and F plugs, so we check the power module.
• Romanian documents. Labels, instructions and X-ray technical files must be in Romanian, so we ask the manufacturer for them early.
• Authorised servicing. Installation and upkeep need a firm with an ANMDMR aviz, and for X-ray one with CNCAN approval too, while spare parts and consumables can ship with the unit.
• Year of manufacture. A used unit needs proof of its age, so the year it was made appears in our papers.

We put open questions to the manufacturer in writing first, since the CNCAN file and the ANMDMR checks both rely on the papers we send.

Customs, CNCAN import papers and ANF wood checks

Romanian customs is the Autoritatea Vamală Română, but we could not open its site. EU rules apply, so the declarant or agent must be based in the EU and hold an EU EORI number. For each order, we send:

• Invoice and packing list for the customs entry
• Transport papers for Constanța or Otopeni
• Origin documents on request
• One HS code per invoice line
• The CE certificate and the year of manufacture

The plant health body, ANF, applies the EU rule that wood packaging from outside the EU must carry the ISPM 15 mark and the number of the unit that treated it. Its border posts include Constanța Nord, Constanța Sud-Agigea and Henri Coandă Airport. Crates from the manufacturer should therefore be heat-treated and stamped.

Constanța by sea, Bucharest by air

1. Model and aviz holder. Send the model, quantity and site by RFQ form or email, and name the importer that holds the ANMDMR aviz.
2. Quote and documents. Expect a catalogue quote within 48 hours as a rule, with certification, lead time, the route and the Romanian papers.
3. Confirmation in writing. The maker receives the order once you confirm the quote in writing.
4. Black Sea or air. Sea freight goes to the Port of Constanța, where DP World runs the Constanța South Container Terminal, and air freight goes to Henri Coandă Airport in Bucharest.

Our delivery ends at the gateway you name, and your declarant then clears the goods with Romanian customs. The road to site is yours.

Single units, new regional centres and second-hand rules

Single units are fine on most catalogue lines, so a clinic in Brașov can ask for just one ultrasound scanner. Larger projects, such as a diagnostic imaging suite, can start from hospital setup, and neonatal units can browse Women, Children and Neonatal. Our refurbished range can serve Romania under the second-hand rules. A used unit must carry the CE mark, and it may be used only after ANMDMR has tested its performance and issued an aviz. When it first comes onto the Romanian market, it must have at least three years left of its normal working life, and its age must be on file.

Disclaimer

This page is a planning aid for Romanian buyers. It contains no offer to supply, and none of it is legal, regulatory or customs advice. Quotes follow what makers can supply, and an order exists only when both sides agree to it in writing. Devices need Romanian labels and an importer with an ANMDMR aviz, and X-ray units need CNCAN registration or authorisation. You and your importer handle clearance and the regulatory steps, as we do not hold a Romanian aviz.