Buy Medical Equipment in Portugal

Portuguese texts before shipment

In Portugal, Decree-Law 29/2024 implements the EU device regulation and designates INFARMED as the competent authority. Medical devices in Portugal need Portuguese labels and instructions for use. INFARMED may grant a dispensation for certain groups of devices or users, and since April 2025, this has covered the screens of devices for professional use. A unit shipped from Great Britain is also a non-EU import, so a quote for Portugal starts with the texts and the CE file.

Working as MediGear, we are a medical equipment distributor registered in England and Wales. Healthcare buyers in more than 80 countries come to us for quotes, documents and freight on medical equipment and supplies. For imaging equipment in Portugal, we look for verified makers. They must supply Portuguese labels and instructions, and the Portuguese X-ray information the law requires before delivery. We work through the points below with the maker before any quote for Portugal medical equipment and devices goes to your engineers. Use the buyers page to send a request; no account is required.

Local Health Units, oncology institutes and private groups

Since January 2024, the health system in Portugal has run public care through Local Health Units, and we quote for:

• ULS de Santa Maria and ULS de São José in Lisbon
• ULS de São João and ULS de Santo António in Porto
• ULS de Coimbra, ULS de Braga and the IPO oncology institutes
• Private groups in the Portuguese healthcare sector, such as CUF and Lusíadas Saúde, and sterile services teams
• Imaging, dental and veterinary clinics with X-ray units or other diagnostic imaging devices
• Hospitals in Portugal's Azores and Madeira
• Medical device companies in Portugal notified to INFARMED

Public procurement contracts, including those for Portugal's healthcare infrastructure, are published on BASE, run by IMPIC, and EU-level tenders appear on TED. SPMS, the health ministry's shared-services body, acts as the central purchasing body for the SNS, the national health service, within Portugal's healthcare system. A clinic replacing a single unit of medical diagnostic equipment can start with nothing more than its model number, and the first reply says what we can quote.

INFARMED, SIDM and Portuguese labels

Decree-Law 29/2024 makes the supply of devices for resale or for use in health services subject to notification to INFARMED. Distributors need a technical director and proper premises. They send INFARMED their device lists electronically, with labels and instructions. They also keep transaction records for five years. A hospital, or a distributor in Portugal, that brings a unit in from outside the EU should ask its own advisers who hold the importer's role.

INFARMED notifications sit with Portuguese firms, not with us, and we give no regulatory advice, but the quote does list the unit's certificates. Only firms with a quality management system, such as oN ISO 13485, may maintain, calibrate, or provide technical assistance on medical devices.

ERS, APA and X-ray information in Portuguese

Since 1 July 2024, the Entidade Reguladora da Saúde (ERS) has handled radiation protection for medical exposures. The environment agency APA handles other practices, such as veterinary X-ray. Most medical X-ray needs a licence. Dental units, including intraoral, panoramic and CBCT, bone densitometry and veterinary units need registration. A mobile X-ray solution for a veterinary practice is registered like a fixed one, since veterinary X-ray is registered whether or not it stands at a fixed site. For medical exposure, the holder must be a healthcare provider whose site is registered with ERS where the equipment stands. Medical exposure practices are subject to prior control, and ERS authorises the practice through a registration or licence certificate.

An X-ray generator must come with information on its risks, use, testing and maintenance, written in Portuguese and supplied before delivery. The manufacturer or importer must also train the users. ERS guidance asks for acceptance tests before patient use, within a quality assurance programme. We found no national test intervals, so we send the maker's schedules with the quote. Since January 2026, intraoral dental units have had their own rules, with registration renewed every five years.

230 V, Portuguese texts and ISO 13485 service

The maker answers these questions before we quote:

• Wall sockets. Mains power in Portugal is 230 V at 50 Hz, and the IEC lists type C and F plugs, so we confirm the power module.
• Portuguese texts. Labels and instructions must be in Portuguese, and the April 2025 dispensation covers the screens of professional-use devices, so we check the manufacturer's translations.
• Certified servicing. Servicing medical technology in Portugal requires a firm with a quality management system, so we ask who services the unit and whether spare parts and consumables can be shipped with it.
• User training. For X-ray generators, the manufacturer or importer must train the users, so we confirm what training the maker offers.

Open points go to the maker in writing, because the Portuguese texts and the training must be ready before the unit is delivered.

STADA Importação, CE papers and DGAV wood rules

The Autoridade Tributária e Aduaneira (AT) takes import declarations through STADA Importação. Anyone entitled to present the goods may lodge one; a customs representative is optional, and an importer filing for itself must register with the AT first. Each Portuguese order travels with:

• The invoice and packing list for the AT declaration
• Sea or air waybill copies for the declarant
• Origin papers where the declaration needs them
• HS codes against each invoice item
• The CE declaration of conformity and certificate

For wood packaging from outside the EU, DGAV has applied ISPM 15 since March 2005. The wood is treated, debarked and marked on each unit, and no phytosanitary certificate is needed. Conifer packaging sent from the mainland to the Azores or Madeira must also meet ISPM 15, so we ask makers for heat-treated, stamped crates.

Lisbon, Leixões, Sines and the islands

1. Request and texts. Send the model, quantity, and site via the RFQ form or email, and say whether Portuguese texts are already in hand.
2. Documented quote. Catalogue lines are usually quoted within 48 hours, with the certificates, lead time, route and Portuguese papers set out.
3. Written order. Once you confirm the quote in writing, the order goes to the maker.
4. Landing point. Sea freight arrives at the Alcântara or Santa Apolónia terminals in Lisbon, Leixões near Porto,o or Sines, and air freight arrives at Lisbon or Porto airports.

Our delivery stops at the port or airport you name. There, you or your customs representative lodge the import declaration through STADA. The last leg is yours, including onward shipping to the Azores through Portos dos Açores or to Madeira through APRAM. Please tell us if you prefer sea or air, and the quote will follow that route.

Single units, a new hospital or pre-owned systems

Single-unit requests are welcome from clinics and hospitals across the healthcare system in Portugal, on most catalogue lines, such as one ultrasound unit for a clinic in Faro. For a new site, see clinic setup, and endoscopy teams can browse Gastroenterology Equipment. We found no provision on used or refurbished devices in Decree-Law 29/2024, so our refurbished range can serve Portugal. The usual rules stay: EU conformity and the CE mark when the unit first enters the EU market, Portuguese texts, servicing by certified firms and the X-ray licence or registration.

Disclaimer

Nothing on this page is an offer to supply, and none of it is legal, regulatory or customs advice for Portuguese buyers. It is general information from the official sources we could open. The maker's supply sets what we can quote, and nothing is ordered before both sides agree in writing. Devices need Portuguese labels and instructions, and X-ray units need an ERS licence or registration before use. You and your representative handle clearance, the INFARMED notification, and the regulatory side, because we are not a Portuguese importer or distributor.