Medical Device Registration in
Portugal
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