Tested on installation, cleared for clinical use
The company that supplies or installs an X-ray unit in Malta hospital departments, clinic rooms, or dental practices tests its safety features on installation, whether the unit is new, second-hand, refurbished, or relocated. Next comes an acceptance test to a standard the Radiation Commission accepts, and the report goes to the Commission's Secretariat, which must clear the unit before it is used on patients. The hospital or practice remains responsible for ensuring the equipment is fit for use, so these steps shape a quote from the start for the health care system in Malta.
We are MediGear, and our company is registered in England and Wales. As a medical equipment distributor, we provide quotes, prepare documents, and arrange freight for healthcare buyers in more than 80 countries. For healthcare in Malta, we look for verified manufacturers who can supply the model with Maltese or English texts and the documentation the Secretariat expects. That way, the quote your engineers and purchasing team receive already answers the points below. You can send requests through our buyers page without opening an account.
Mater Dei, Gozo and the Malta healthcare system
We quote for buyers including:
- Mater Dei Hospital, the state-run acute teaching hospital
- The oncology centre in Msida and Gozo General Hospital
- Karin Grech Rehabilitation Hospital and St Vincent De Paul
- Saint James Hospital Malta and eye clinics
- Licensed private clinics and laboratories, with their laboratory equipment
- Dental practices with X-ray and CBCT units
- Importers and distributors on the MMA list
Within Malta's healthcare system, public health buying runs through the CPSU. It manages supplies for the state's health services, while the Department of Contracts runs larger tenders through e-PPS. Mater Dei, part of Malta's health system, is adding capacity: work began on 17 August 2026 to double the emergency department from 35 to 70 cubicles and build a 135-bed acute mental health unit. For a private clinic, a single replacement unit is enough to start a quote.
The Medicines Authority, MDRPs and local notices
The Malta Medicines Authority (MMA) is the national authority for medical devices. Its 2020 rules cover supplying devices in Malta. Anyone who imports, wholesales, makes, or repurposes devices in Malta needs MMA approval and a medical device registered person, or MDRP, based in Malta. Devices sold locally are entered into the national database via form MT-MDF05, and the MMA also lists the importers and distributors it has registered. Operators complete form MT-MDF02 for registration of medical devices, with a Malta Business Register number, and importers and distributors provide their MDRP number.
Labels and instructions may be in Maltese, English or both. Since we are not a Maltese importer or MDRP, we give no regulatory advice, though each quote names the certificates the unit holds.
The Commission, registrations and two-yearly tests
The radiation regulator is the Commission for the Protection from Ionising and Non-Ionising Radiation, and its Secretariat grants approvals. Medical X-ray needs a registration or a licence, and the Commission decides which on a graded basis. A practice must be notified at least 30 days before it starts, unless an application is made instead, and all forms and notices go through one e-service. The practice itself gives that 30-day notice, and one installing its first X-ray unit in Malta follows the same rule. The Commission also publishes lists of approved medical physics and radiation protection experts.
A radiation protection expert reviews plans for each room and checks new or changed units into service. Acceptance tests run when a unit is installed or relocated, and again after major repairs, part changes or unusual doses, and records are kept for the life of the unit. Constancy tests follow at least every two years, and dental units are tested every two years in the same month, or a stop order follows. The Secretariat must be told before a withdrawn unit is sold, leased or given to another approved user.
230 V supply, type G sockets and myHealth
Four points are agreed with the manufacturer first:
- Supply. Enemalta provides 230 V phase-to-neutral and 400 V phase-to-phase at 50 Hz, and the IEC lists type G plugs, so a 60 Hz design needs another build.
- Installer tests. The company that supplies or installs the X-ray generator system tests its safety features and warning devices, and the site keeps the results.
- Spares for Gozo. The Ċirkewwa reaches Gozo to Mġarr ferry, so spare parts and consumables for a Gozo site are worth shipping with the unit.
- myHealth. Patients and doctors see lab results, scans, imaging reports and ECGs on myHealth, so your IT team should confirm the DICOM and HL7 links of each biomedical system.
Open points go to the manufacturer in writing before we quote, since the site must have adequate information on the equipment before it acquires it.
NIES declarations and plant health checks
Malta Customs Operations, part of the MTCA, takes declarations through NIES, the national import and export system. A declarant may act for itself or for others with the Commissioner's permission, and a customs agent needs approval, an EORI number and a base in the EU. The MMA also checks customs papers and product compliance, which takes 30 working days, and its Letter of Compliance is valid for one year. Each consignment comes with:
- Commercial invoice and the packing list
- Bill of lading, or air waybill for flown items
- Origin papers where needed
- An HS code per item
- The CE file, labels and instructions
The Food Safety and Security Authority runs plant health. The Plant Health Directorate clears plant goods before release. Under EU rules, wood packaging from outside the EU must carry the ISPM 15 mark, and Maltese law allows imports that fail to be destroyed, treated, or otherwise dealt with. Crates should therefore be heat-treated and stamped, and we ask manufacturers to do so.
Marsa, the Freeport and the Gozo ferry
- Send the model. Send the model, quantity, and site via RFQ form or email, and name your importer or MDRP.
- Get the quote. Most catalogue quotes come back within 48 hours and cover certification, lead time, the port and the test papers.
- Give the go-ahead. Once you confirm in writing, the order goes to the manufacturer.
- Harbour or airport. Sea freight into Valletta Gateway Terminals at Marsa, or air freight into Malta International Airport, while Malta Freeport is mainly a transhipment hub.
Delivery ends at the port or airport you nominate, where your agent lodges the declaration in NIES, and the last leg is yours, including the Ċirkewwa to Mġarr ferry for a Gozo site.
Single units, ward projects and second-hand X-ray
If a clinic in Gozo wants a single autoclave or a single imaging plate and cassette for a unit it already has, it can be quoted on most catalogue lines. Larger work can follow hospital setup, and imaging teams, such as the medical imaging department at Mater Dei, can browse Medical Diagnostic Equipment. For wards, mobile direct digital X-ray machines are quoted the same way, and the tests and clearance above still apply. Pre-owned units are in our refurbished range, and our search found no Maltese ban or age limit on them. The radiation rules name second-hand and refurbished units, so they get the same tests and clearance as new ones. Older units with no standard of their own may be judged on EU criteria.
Disclaimer
The content here is general and meant to help Maltese buyers plan. No offer to supply is made here, and none of it counts as legal, regulatory or customs advice. A quote reflects what the manufacturer can supply, and an order is binding only once both sides agree to it in writing. Devices need Maltese or English texts and must follow the MMA's local rules, and X-ray units need the Commission's approval and clearance. Clearance and the rules stay with you and your agent, since we are not a Maltese importer or MDRP.
Who will run the acceptance test?
In Malta, the supplier or installer tests an X-ray unit's safety features on installation, and the Secretariat clears it for clinical use after acceptance. Send the model and site, and we'll quote with the CE file, test details and route.
Frequently Asked Questions
Enter the model number or a specification in the RFQ form on the buyer's page, or email it to connect@medigear.uk. There is nothing to register. We quote for Mater Dei and other public services, including primary health and community care, private hospitals and clinics, dental practices and Maltese distributors.
Maltese, English or both. The EU table for Malta shows Maltese and/or English for labels, instructions, implant cards, declarations of conformity and field safety notices, and we check the maker's documents against this before quoting. English alone meets the rule.
A medical device registered person in Malta. An operator importing, wholesaling, or making devices available in Malta needs MMA authorisation and at least one MDRP, who holds the declaration, labels, and instructions, and handles complaints, incidents, and recalls.
It goes through the same steps as a new one: safety tests by the supplier or installer, an acceptance test and clearance from the Secretariat for clinical use. Older units without a standard may be judged against EU acceptability criteria, and the site keeps the test records.
Consignment tests are due every two years, in the same calendar month as the previous test, and a missed test leads to a stop order. Initial acceptance reports go to the Commission, and only registered dentists and radiographers operate intraoral units.
We deliver to the port or airport you nominate, such as Valletta Gateway Terminals at Marsa or Malta International Airport, and Malta Freeport is mainly a transhipment hub. For a Gozo site, the last leg runs on the Ċirkewwa to Mġarr ferry, which you arrange.
A documentation and product compliance check on form MT-MDF22. Applicants send declarations, certificates, instructions, labels, a photo of the shipment at customs and shipping papers. It takes 30 working days, and the Letter of Compliance is valid for one year.
Yes. Most catalogue lines can be quoted for a single unit, such as a skeletal X-ray machine for a clinic, and a minimum order set by the maker would appear in our first reply. Lead time and route are included in the quote, and email updates follow dispatch.