Medical Device Registration in


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:      



Class I, IIa, IIb and III

Medical Device Registration in Portugal:

  • 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:          


License Validity:          

1 year


Want to know more about this registration process?