Portuguese MedTech Market: Overview of Opportunities and Requirements for Manufacturers

Escrito por Commercial 4Easy PRRC

A recent presentation published by APORMED provides an updated overview of the Portuguese MedTech market, including key economic indicators, market size, healthcare structure, and regulatory requirements relevant for companies operating or planning to enter Portugal.

Market Size and Growth

According to APORMED, the Portuguese MedTech market reached €2.486 billion in 2024, with:

  • €900 million corresponding to NHS purchases

  • €600 million in exports

Between 2019 and 2024, the market recorded a total growth of 52.7%, with an average annual growth rate of 9.08% .

These figures reflect sustained expansion across several product segments, including cardiology, orthopaedics, imaging, and general medical equipment (as illustrated in the market trends section of the document).

Economic and Demographic Context

Portugal presents stable macroeconomic indicators, including:

  • GDP: €306 billion

  • Growth: 1.9%

  • Inflation: 2.3%

  • Unemployment: 5.9%

From a demographic perspective:

  • Population: 10.58 million

  • Population aged over 65: 24.5%

  • Life expectancy: 81.7 years

This demographic profile indicates an ageing population, which is typically associated with increased demand for healthcare services and medical technologies.

Healthcare System Structure

Portugal operates a mixed healthcare system, combining public and private components.

National Health Service (SNS)

  • Largest segment of the market

  • Funded through the national budget

  • Provides primary, secondary and tertiary care

  • Covers the entire territory through 39 Local Health Units (ULS)

Private Sector

  • Includes voluntary private insurance (growing segment, +17.3% in 2024)

  • Allows direct agreements between suppliers and healthcare providers

Social Insurance

  • Still present but decreasing in relevance

  • Limited to specific professional groups

Market Access Conditions

Public Sector (NHS)

Access to public hospitals is regulated by national and European public procurement rules.

Key characteristics include:

  • Purchases predominantly based on price criteria

  • Limited use of value-based procurement

  • Requirement for a Medical Device Code (CDM) for participation in tenders

In addition, some reimbursement mechanisms exist for specific products, medicines and diagnostic procedures.

Private Sector

Private hospitals are not required to follow public procurement rules and may:

  • Establish direct agreements with suppliers

  • Operate under reimbursement frameworks defined by private insurers

Some insurers maintain lists of reimbursable devices, particularly for implantable products .

Local Regulatory Requirements

Device Registration and Coding

In Portugal, medical devices must comply with local registration requirements, including:

  • Company registration in Licenciamento+

  • Device registration in SIDM

  • Attribution of a local device code (CDM)

The CDM system is used for procurement, traceability and healthcare system management, and is mandatory for NHS acquisitions .

Currently, this system operates in parallel with EUDAMED, requiring companies to register information in both databases. Integration is expected in the future .

Distribution Requirements

Medical devices cannot be placed on the Portuguese market directly from non-EU countries. Products must enter through the European Union supply chain, typically via an importer or authorised distributor .

Companies are also required to appoint a Technical Manager responsible for ensuring compliance with local regulations.

Language Requirements

All documentation related to medical devices must be provided in Portuguese, including:

  • Labelling

  • Instructions for Use (IFU)

  • Certificates and declarations

Exceptions may be granted on a case-by-case basis. Recently, authorities have allowed certain devices for professional use with English-language interfaces, subject to specific conditions .

Reimbursement and Additional Access Pathways

Only a limited number of medical devices are reimbursed by the NHS, mainly in areas such as:

  • Diabetes care

  • Ostomy

  • Incontinence

Maximum final prices are regulated, while intermediary prices are subject to negotiation .

An additional pathway is the Support Products Assignment System (SAPA), particularly relevant for assistive technologies and, to a lesser extent, hearing devices .

Key Stakeholders

Several public entities play a central role in the Portuguese MedTech ecosystem, including:

  • INFARMED – Competent Authority and HTA body

  • ACSS – NHS financing and administration

  • SPMS – Centralised procurement and digital services

  • ERS – Healthcare provider regulation

  • AICEP – Investment and internationalisation support

Conclusion

The Portuguese MedTech market shows consistent growth and a structured healthcare system with defined access pathways. At the same time, it includes specific national requirements, particularly in areas such as procurement, device coding, and language compliance.

For manufacturers, understanding these elements is essential when planning market entry and commercialisation strategies in Portugal.

The full document can be accessed below.

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