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.
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 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 Process for INFARMED
Process for Non-EU Manufacturer
Distributors and Authorized Representative Registration
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