Medical Device Registration in Portugal
Regulatory Authority of Portugal
The Portuguese Regulatory Authority (RA) is INFARMED (Autoridade Nacional do Medicamento e Produtos de Saúde / National Authority of Medicines and Health Products), an agency within the Portuguese Ministry of Health, which evaluates, authorizes, regulates, and supervises the market, regardless of the origin of the devices, guaranteeing the protection of public health.
Portugal INFARMED Registration Requirement
145/2009 published on 17 June 2009 and transposed into Portuguese law Directive No. 2007/47/CE of European Parliament and Council, All Medical Devices must have CE marking and must be registered online with the national regulatory authority, INFARMED.
If the Manufacturer is headquartered outside the European Union, the requirements under the Portuguese regulation must be completed by a legal representative in the Community or, European Authorized Representative (AR).
INFARMED has developed their own registration system in which manufacturers or Authorized Representatives can register their devices.
A single AR may only represent the manufacturer for each type of device. Thus, to enter the Portuguese market of medical devices, manufacturers of medical devices are required to appoint an AR, which will assist with all the details regarding the registration process and assist in completing requirements under the Portuguese regulation.
Registration of medical devices can be done here: https://www.infarmed.pt/web/infarmed-en/about-infarmed.
Timeline for Portugal Infarmed registration
As part of market surveillance is essential to know the devices and those responsible for placing on the market so, the following requirements for registration / notification of medical devices for manufacturers or their representatives are established:
- Registration of Class I Medical Device by national manufacturers
- Registration of Custom-Made Medical Device by national manufacturers
- Registration of systems or procedure packs by national manufacturers (assemblers)
- Registration of class IIa, IIb, III and implantable active medical devices by national and non-national manufacturers
- Registration of in vitro diagnostic medical devices by national manufacturers
- Registration of in vitro diagnostic medical devices by non-national manufacturer
Registration Process for Portugal INFARMED Registration
- Create a login ID
- Register the manufacturer and AR
- Upload the relevant document
- Submit the application
Process for Non-EU Manufacturer
- Designation of European Authorized Representative
- Provide your European Authorized Representative with relevant documentation
- Document review
- Registration with INFARMED
Distributors and Authorized Representative Registration
- A new Distributor should be registered only when this entity is not present in the Distributors list, available when registering a new MD.
- If the Manufacturer, using the on-line registration system, is placed outside European Union, he shall register the data concerning its Authorized Representative.
Documentation Requirement for Portugal INFARMED Registration
- CE Conformity Certificates
- EC Declaration of Conformity (must be in Portuguese)
- Labelling and instructions for use, including the calibration instructions (must be in Portuguese)
- Maintenance manual
- Technical file
- Medical Devices Department usual contacts
- Date when device was placed in the market
What We Offer?
- Act as your Authorized Representative
- Register your medical devices in the INFARMED
- Keep you up to date with the Portugal regulatory requirement
Why Choose Us?
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: [email protected]