Regulatory Authority

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


I, IIa, IIb, III

Quality system

ISO 13485:2016

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.


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.


1 year.

Labelling 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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