Portugal INFARMED Registration
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.
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: 1 Month
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 INFARMED
Create a login ID
Register the Manufacturer and Authorized Representative (AR)
Upload relevant documentation
Submit the application
Application review and processing
Registration with INFARMED
Process for Non-EU Manufacturer
- Designation of a European Authorized Representative
- Provide the Authorized Representative with all relevant documentation
- Document review and verification
- Final registration with INFARMED
What We Offer
- Act as your European Authorized Representative
- Register your medical devices with INFARMED
- Ongoing regulatory compliance support for Portugal
- Regulatory updates and post-market guidance
Why Choose Us?
Client Satisfaction
Focused on long-term client partnerships
Cost-Effective Solutions
Practical and affordable regulatory strategies
On-Time Project Delivery
Meeting deadlines without compromise
Regulatory Expertise
High-quality regulatory affairs solutions
Documentation Requirement
- CE Conformity Certificates
- EC Declaration of Conformity (Portuguese)
- Labelling & Instructions for Use (Portuguese)
- Calibration instructions
- Maintenance manual
- Technical file
- Medical Devices Department contact details
- Date when device was placed on the market
Distributors & Authorized Representative Registration
A new distributor must be registered only if the entity is not already listed in the
Distributors database available during medical device registration.
If the manufacturer is located outside the European Union, details of the European
Authorized Representative must be registered through the online system.
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