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.

Documents Required:          

• CE Mark
• Declaration of Conformity
• Technical documents & Application Form
• QMS Certificate
• Labels, IFUs

Post-market surveillance:  

• Initial reports must be submitted:
• Serious threat to public health – 2 days
• Death or High risk to health – 10 days
• Other – 30 days
• The final report should be submitted within 10 days after the investigation conclusion

Applicable QMS:          

ISO 13485

Registration Timeline:         

1 – 9 months

Authorized Representative:          

Yes

License Validity:          

1 year