In Portugal, Infarmed is the Competent Authority for the area of medical devices. Ensures the products respect the legal requirements as set out in European Directives. Ensures the products do not endanger the health and safety of patients and users..

Infarmed has jurisdiction over medical devices, active medical devices, systems and assemblies of medical devices, medical device made to measure, implantable medical devices and active implantable medical devices, medical device made to measure for in vitro diagnostic, medical devices intended for investigations.

Medical devices are divided into four risk classes: Class I medical devices – low risk, Class IIa medical devices – medium risk, Class IIb medical devices – medium risk, and Class III medical devices – high risk.

A device to be sold in the Portuguese market must be registered at Infarmed.

The Decree-Law n. º 145/2009 of 17 June establishes,, with respect to medical devices placed on the Portuguese market, the registration of manufacturers, representatives (Article 11. º) and Distributors (Article 41. º).

The Decree-Law n. º 145/2009 of 17 June establishes, with respect to in vitro diagnostic medical device placed on the Portuguese market, the registration of manufacturers, representatives (Article 10. º) and Distributors (Article 12. º).

The registration of medical devices and in vitro diagnostic medical device, is performed on the online platform of the regulatory authority.

We ensure compliance with the standards set out in Decree-Law n. º 145/2009 of 6/17 and No. 189/2000, 12/8, for manufacturers, distributors and agents. We ensure all stages of the process for registration of medical devices and in vitro diagnostic device (IVD), near the regulatory authority.