Portugal

The information on this page is valid and current as of october 2020. The legislative and regulatory provisions are subject to changes and updates by the Regulatory Authorities of the State to which they refer. Considering the above, the writer declines all responsibility regarding any non-actuality and/or inaccuracy of the information received concurrently with or following the publication of this page. Disclaimer


Regulatory Authority:
Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED).

Classification:
Class I, Class IIa, Class IIb, Class III.

Quality system:
In compliance with ISO 13485:2016 technical standard.

Procedure:
All Medical Devices are subject to registration.
In the case of a non-European Manufacturer it is necessary to appoint a European Authorized Representative.
Normally, CE marking is required.
All devices must be registered.
All Class I devices must be registered with the European Competent Authority of the place where the Manufacturer/Authorized Representative is established, except for Portuguese Manufacturers/Authorized Representatives who must register with the Portuguese Authority.
The Manufacturer/Authorized Representative of Class IIa, IIb and III devices or active implantable devices must notify the competent Authority through the registration procedure on INFARMED online database.

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Applicant:
Authorized Representative or Manufacturer.

Timeframe and fees:
Timeframe: 1-9 months.
There is a fee that varies based on the amount of material submitted for registration.

Validity:
1 year.

Labeling and documentation language:
The information on the label and the instructions for use must be in Portuguese.

Useful information:
The site of the Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED) is constantly updated in Portuguese.
Like all the Countries of the European Union, Portugal will also adopt the New Regulation (EU) 2017/745 on Medical Devices.
It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.

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