Buy Medical Equipment in Italy

Diagnostic imaging in Italy: dose rules for CT since 2020

Under Italy's 2020 radiation decree, a CT or interventional unit purchased after 27 August 2020 must display the dose at the end of each exam. It must also have systems to optimise dose and send dose data to the exam record. A practice must notify its medical X-ray equipment at least 10 days before it starts. Each X-ray unit is reported to ISIN, the national radiation inspectorate. These points shape a quote for X-ray and CT units in medical imaging, and they matter most for a pre-owned scanner.

We're MediGear, and we distribute medical equipment. Because our company is registered in England and Wales, we are not part of Italian hospital distribution: we quote supply from outside the EU. We work with healthcare buyers in more than 80 countries, from quote to freight. From a model number or clinical need, we find verified manufacturers that can supply hospital equipment in Italy with Italian documentation. Your engineers and procurement office see the quote only after we check the points on this page. The buyers page is where anyone buying for healthcare in Italy sends a request, and it requires no account.

Hospital types in Italy: IRCCS, university trusts and private groups

Requests for Italy hospital supplies reach us from public trusts, research hospitals and private groups:

• Policlinico Gemelli in Rome, which opened two new CT rooms in October 2026
• Niguarda Hospital and the Policlinico di Milano, where a new hospital is being built
• Turin's Città della Salute, where works on the 1,040-bed Parco della Salute should start in early 2027
• Private groups such as Humanitas, with 11 institutions, and day surgery units
• IRCCS Policlinico di Sant'Orsola in Bologna and other university hospitals
• Dental and veterinary practices, which report their X-ray units in STRIMS
• Medical device distributors in Italy registered in the Ministry's national database

Under the 2023 procurement code, public procurement has used digital platforms since 1 January 2024. Consip runs Acquisti in Rete, which includes MePA, and most regions have their own central buyer. Publicly owned hospitals in Italy buy directly or through one of them. A private practice replacing a single ultrasound unit asks for a quote and compares, like any other buyer in the Italian healthcare system.

The Ministry, the national database and Italian texts

The Ministry of Health is the competent authority under Decree 137/2022, which brought Italian law into line with the EU Medical Devices Regulation. Information and instructions for users and patients must be in Italian when the device is delivered to the end user. Implant-card instructions must be in Italian and English. A distributor making devices available in Italy must register in the Ministry's national database, update changes within 30 days and confirm its data every two years.

Economic operators also register in EUDAMED. Under the regulation, the importer's role must be held in the EU, so who holds it when an Italian hospital buys straight from a UK supplier like us is for the hospital and its own advisers to determine. We are not an Italian importer or registered distributor, and we do not advise on regulation. Every quote still lists the certificates the unit holds.

Notice: STRIMS and the 2020 decree

Decree 101/2020 applies the EU safety standards, and ISIN, the national inspectorate for nuclear safety and radiation protection, runs the STRIMS register. A practice with medical X-ray equipment must notify the fire brigade, health-service bodies and the regional environmental agency at least 10 days before it starts. A prior authorisation, the nulla osta, applies to radiotherapy, nuclear medicine and mobile X-ray units of 200 keV or more.

Holders report the start and end of holding each unit through STRIMS. Medical users may report starts quarterly and ends once a year. Acceptance tests come before first use, then checks at regular intervals and after relevant maintenance, under a protocol from the medical physics specialist. Fluoroscopy without image intensification or dose-rate control is banned.

Sockets, dose indicators and the FSE

For diagnostic imaging devices, we ask the maker to confirm, in writing:

• Sockets and mains. Plugs are type C or F under the IEC tables, and the supply is 230 V at 50 Hz. A unit designed for 110 V or 60 Hz needs another build, so we raise it with the maker first.
• Dose display. Interventional, CT and specialist X-ray units acquired after 27 August 2020 must show and record dose data, so check the data sheet.
• Service parts. Tubes, probes and filters wear out, and spare parts and consumables can ship with the unit.
• FSE links. Reports go into the Fascicolo sanitario elettronico 2.0, the national e-health record, so agree the data links with your IT team early.

We put open questions to the maker in writing before quoting. A missing dose feature is hard to add once the unit is installed.

ADM declarations and plant health posts

Customs is run by the Agenzia delle Dogane e dei Monopoli (ADM), under Decree 141/2024, which replaced the 1973 customs act in October 2024. An importer declares personally or through a customs representative, such as a registered customs broker. An operator not established in the EU must be represented by one that is. The documents per order:

• The commercial invoice, plus a packing list
• Origin proof, if the declaration calls for it
• HS codes for every item
• The CE file, including the declaration of conformity
• Information and instructions in Italian

The Servizio Fitosanitario Nazionale checks plant goods at 34 border control posts, 25 at ports and 9 at airports, and timber at most of them. Wood packaging from outside the EU must carry the ISPM 15 mark, and under EU rules, wood that fails is destroyed, sent back or treated. That is why we ask makers for crates marked to ISPM 15.

Genoa, Gioia Tauro and the islands

1. Model, quantity, site. Send them by RFQ form or email, and say whether the unit is new or pre-owned.
2. Read the dose notes. Catalogue quotes usually arrive within 48 hours, with the certificates, lead time, the port and, for CT, the dose features.
3. Written approval. The maker receives the order only after you approve the quote in writing.
4. Ports and cargo cities. Smaller items fly into Malpensa or Fiumicino, while sea freight goes into Genoa, La Spezia, Livorno or Gioia Tauro.

Our delivery point is the port or airport you nominate, where your customs representative handles the import declaration on your behalf, and the last leg is yours. Sicily and Sardinia have their own entry ports, such as Palermo, Catania and Cagliari.

Italy refurbished medical equipment and used CT rules.

A practice in Naples ordering one autoclave gets the same documented quote as a trust ordering forty, on most catalogue lines. A hospital opening a new ward can follow hospital setup, and labs can browse Lab, Pathology and Blood Bank for laboratory equipment. Pre-owned units are in our refurbished range. We found no Italian rule that bans refurbished medical devices, though the 2020 decree still sets conditions. A CT or interventional unit bought now must report and optimise dose, so an older model without those features may not be accepted. Every used X-ray unit also needs its 10-day notice, STRIMS reporting and an acceptance test.

Disclaimer

General information is all this page offers Italian buyers: no offer to supply, and no legal, regulatory or customs advice. A quote reflects the maker's stock at the time, and an order binds both sides only once it is agreed in writing. Devices require Italian-language information, and medical X-ray devices require their notice and STRIMS reporting. Clearance and the regulatory position are matters for you and your customs representative, as we are not an Italian importer or distributor.