Portugal - Country Commercial Guide
Medical Equipment and Devices
Last published date:

Overview

Portugal’s imports of medical equipment and devices make a fundamental component of this market. The health sector is a major, fast-evolving sector in Portugal, which has experienced a remarkable evolution during the past two decades. In April 2021, Portugal’s pharmaceutical products exports accounted for up to 116 million euros, and imports accounted for up to 327 million euros, resulting in a negative trade balance of 211 million euros. The growth of the medical device market is limited by low health expenditure, particularly in the public sector. 

In 2022 Portugal’s budget allocation for health care increased by 6.7% compared to 2021, resulting from the COVID pandemic response.  Approximately 90% of National Health System (NHS, referred to as SNS in Portuguese) funding comes from the State Budget (OE), which historically represents 4.5% of the country’s GDP.

Portuguese expenditures on medical equipment concentrate in the public sector at 80%, especially in public hospitals, while sales to private entities share the remaining 20%.  Foreign products penetrate a considerable portion of the market, which is also receptive to U.S. products.   Price is a critical factor in all purchasing decisions, both by the public and private sectors.  

In 2019, the U.S. ranked 9th among the top 20 suppliers of medical devices to Portugal.  The top counties that supply medical devices to Portugal are France, Germany, and Japan.  Major U.S. companies with offices and distribution in Portugal include GE Medical Systems, 3M, and Johnson & Johnson medical.  Siemens and Philips also have a strong presence in the country.

Portugal has approximately 200 companies distributing medical products, primarily comprised of small or medium-sized companies employing, on average, 15 to 60 people. 

To enter the Portuguese medical equipment market, U.S. suppliers should be familiar with the EU directives, such as product registration, CE mark, marketing, and health/safety standards.  In addition, U.S. suppliers should also be aware of Portugal-specific regulations, which are considered strict among the EU member states.  It is advisable to partner with a local partner/distributor.

As a member of the EU, Portugal follows directives from the European Commission (EC) and the same medical device classification as all other EU member states.  Medical devices are classified according to risk into Classes I, IIa, IIb and III. 

Before manufacturers can start marketing their medical devices in Portugal, they must make sure that their product has been CE-marked, which signifies the product’s conformity with current EU regulations, allowing the device to be sold freely in the EU market.  The CE marking has its own design and must be applied by the manufacturer in a legible, visible, and indelible form on all medical devices, except those that are custom-made or intended for clinical research. 

All medical devices are subject to conformity assessment. However, for some classes, the involvement of a third party – the Notified Body – in this assessment is required.  The Notified Body is an evaluation body appointed by the national authority and recognized by the EC, which assigns it a four-digit identity code. This code accompanies the CE marking on the products evaluated by that body. The Notified Body’s functions are as follows: conduct the conformity evaluation procedures; authorize the affixing of the CE marking; issue conformity certificates; renew, or not, certificates of conformity; ensure that the manufacturer complies fully with his duties under the approved quality system; cooperate with the national Regulatory Authorities; cooperate with other Notified Bodies in EU Member-States. 

In addition to the CE marking, all classes of medical devices to be placed on the Portuguese market must go through a device registration process, even though the requirements for registration of Class I medical devices are different than the ones for registration of Class IIa, IIb, III and implantable active medical devices.  

The Portuguese Regulatory Authority (RA) is INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde / National Authority of Medicines and Health Products), an agency within the Portuguese Ministry of Health, which evaluates, authorizes, regulates and supervises the market, regardless of the origin of the devices, guarenteeing the protection of public health. 

Regulation requirements for medical devices and pharmaceuticals may be consulted on Infarmed’s website.

Third-party commercial entities (distributors) are also required to notify the Competent Authorities of all medical devices they are placing on the Portuguese market. They can communicate this to the Authorities through the online registration database, different than the one used by manufacturers themselves. The manufacturer relinquishes an essential part of his control over his product in Portugal by registering his devices through his distributor. If a manufacturer ever decides to end their relationship with their distributor, he would be required to remove the product completely from the market until it is re-registered. 

When a medical device manufacturer has its head office outside the European Economic Area (EEA), it must be represented by an Authorized Representative (AR) established in the EU zone. The representative assumes the manufacturer’s liability before the authorities and other official bodies in the EU. The manufacturer may only be represented by a single AR for each type of device. Thus, to enter the Portuguese market of medical devices, U.S. manufacturers of medical devices are required to appoint an AR, which will assist with all the details regarding the registration process under Portuguese regulation. To complete these requirements, the AR will need to be presented with the following: EC Declaration of Conformity; CE Certificate; Labeling (must be in Portuguese); Instructions For Use (must be in Portuguese); Technical File. After the documentation review, U.S. manufacturers can proceed with the registration with INFARMED. 

Purchases for hospitals under the NHS are centralized at the Shared Services of the Ministry of Health (SPMS), which advertises and opens official tenders.

There is a pre-selection process among the competing companies before the open bid. During pre-selection, the bidding vendors submit a proposal with the product description and their quote to the hospital. After accessing the proposals, the hospital elects the one that best fits. 

Typically, private hospitals do not use tenders and select their suppliers from whom they make direct purchases. Non-EU and U.S. companies need to have either a Portuguese distributor or their own branch in Portugal to participate in official tenders, seek market opportunities and provide the after-sales service and aftermarket support required by law.  

The DGS coordinates the European and international relations of the Ministry of Health. Government medical international tenders bids (http://www.medicaltenders.com/medical_tenders_portugal.htm). Portugal government tenders public tenders business opportunities are also available online.

Leading Sub-Sectors

The best sales potential is the personalized medicine segment together with mini-invasive robotic technologies for surgery, mainly in the areas of cardiology; surgery equipment; patient monitoring systems; mini-invasive surgery (MIS) equipment; noninvasive medial apparatus; video endoscopes; X-Ray equipment; digital image processing; magnetic resonance imaging (MRI) equipment; picture archiving systems.

Opportunities

In 2022, the National Health Service received the most significant funding from the State Budget at 11.1 billion euros, more than 700 million allocations from the previous State Budget. 

The medical market in Portugal shows opportunities for innovative medical devices and diagnostic equipment.  More than 80% of NHS public hospitals use telehealth, with frequent online tracking and teleconsultation.  However, artificial intelligence projects have yet to reach half of the health institutions in Portugal.  There are prospects for advanced digital solutions to integrate with healthcare and telemedicine devices, tele triage, teleconsultation, and telemonitoring systems. 

Resources

Portugal Health Care & Long-Term Care Systems – EU Commission Services report

Regulation requirements for medical devices

Regulation requirements for pharmaceuticals

General Directorate of Health

Government medical tenders (http://www.medicaltenders.com/medical_tenders_portugal.htm)

Key Regulatory Agencies:

Leading Products – NAICS

  • Appliances, surgical, merchant wholesalers – 423450
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  • Home health care supplies merchant wholesalers – 423450
  • Hospital equipment and supplies merchant wholesalers – 423450
  • Surgical appliances merchant wholesalers – 423450