Portugal

Ministry of Health:     

Ministry of Health

Regulatory Authority:          

INFARMED (Autoridade Nacional do Medicamento e Produtos de Saude, I.P)

Medical Device Regulation:          

Decree Law No. 145/2009 of June 17

Official Language:      

Portuguese

Classification:    

Class I, IIa, IIb and III

Registration Process:

• Determine the device classification
• Appoint an Authorized Representative
• Class, I devices must be registered with European Competent Authority
• For Class II and III, devices must notify the Competent Authority through the registration procedure on INFARMED online database.