Portugal's Medical Equipment Market Overview

1. Introduction

Portugal's medical equipment and devices sector is a vital and rapidly evolving part of its healthcare system, which has seen significant advancements over the past two decades. The market is heavily influenced by public sector spending, with approximately 80% of expenditures concentrated in public hospitals. Foreign products, including those from the U.S., hold a substantial market share, though price sensitivity is a key factor in purchasing decisions. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

2. Market Data and Trade Balance

In April 2021, Portugal's pharmaceutical products exports reached 116 million euros, while imports totaled 327 million euros, resulting in a negative trade balance of 211 million euros. The growth of the medical device market is constrained by relatively low health expenditure, particularly in the public sector. In 2022, the health care budget increased by 6.7% compared to 2021, driven by the COVID-19 response. The National Health System (NHS) funding primarily comes from the State Budget, historically representing about 4.5% of GDP. In 2019, the U.S. ranked 9th among the top suppliers of medical devices to Portugal, with leading suppliers being France, Germany, and Japan. There are around 200 distribution companies in Portugal, mostly small to medium-sized enterprises employing 15 to 60 people. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

3. Regulatory Framework

As an EU member, Portugal adheres to European Commission directives, classifying medical devices into risk-based classes (I, IIa, IIb, III). Devices must bear the CE mark to indicate conformity with EU regulations, allowing free movement within the EU. The CE mark must be affixed legibly and indelibly by the manufacturer. For certain classes, a Notified Body's involvement is required, identified by a four-digit code. The Portuguese Regulatory Authority, INFARMED, evaluates, authorizes, regulates, and supervises the market to protect public health. Non-EU manufacturers must appoint an Authorized Representative (AR) in the EU for registration. Required documents include the EC Declaration of Conformity, CE Certificate, labeling and instructions in Portuguese, and the Technical File. All devices must be registered with INFARMED, with different processes for Class I versus higher classes. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

4. Trade Barriers and Market Entry

Public hospital purchases under the NHS are centralized through the Shared Services of the Ministry of Health (SPMS), involving tenders with a pre-selection process. Private hospitals typically make direct purchases without tenders. Non-EU companies need a local distributor or branch in Portugal to participate in tenders and provide after-sales service. Portugal's regulations are considered strict among EU states, requiring familiarity with EU directives on registration, CE marking, marketing, and health/safety standards. Partnering with a local distributor is advisable for market entry. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

5. Leading Sub-Sectors

Promising sub-sectors include personalized medicine and mini-invasive robotic technologies, particularly in cardiology; surgical equipment; patient monitoring systems; mini-invasive surgery (MIS) equipment; noninvasive medical apparatus; video endoscopes; X-ray equipment; digital image processing; magnetic resonance imaging (MRI) equipment; and picture archiving systems. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

6. Opportunities

The 2022 State Budget allocated 11.1 billion euros to the NHS, an increase of over 700 million from the previous year. Opportunities exist for innovative medical devices and diagnostic equipment. Over 80% of NHS public hospitals use telehealth, including online tracking and teleconsultation, but artificial intelligence projects reach less than half of health institutions. There is potential for advanced digital solutions integrated with healthcare and telemedicine devices, such as tele triage, teleconsultation, and telemonitoring systems. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

7. Web Resources

• Portugal Health Care & Long-Term Care Systems – EU Commission Services report
• Regulation requirements for medical devices and pharmaceuticals on Infarmed’s website
• General Directorate of Health
• Government medical tenders Key agencies include the Directorate-General of Health of Portugal, National Health Service, and INFARMED. Source: https://www.trade.gov/country-commercial-guides/portugal-medical-equipment-and-devices

8. Conclusion

Portugal presents a receptive market for U.S. medical equipment, particularly innovative technologies, though navigating EU and local regulations is essential for success.