Portugal, as a member of the European Union follows the same medical device classification as all other EU member states. In the EU classification system we can distinguish four different medical device classes: Class I, Class IIa, Class IIb, and Class III. Class 1 medical devices are considered the least potentially harmful, while medical devices classified as Class III devices pose the highest potential threat to its users.
Overview of the registration process in Portugal
Despite the fact that medical device regulations in Portugal are unified with those of the European Union (EU MDR and IVDR), each EU member state has their own Regulatory Authority (RA). In case of Portugal such RA is Autoridade Nacional do Medicamento e Produtos de Saúde (INFARMED).
Before manufacturers can start marketing their medical devices in Portugal – or any of the EU member states – they must make sure that their product has been CE-marked. CE marking is a sign of conformity with current EU regulations that allows for the device to be sold in any country belonging to the European Union – regardless of where it has been registered. As long as our medical device is registered in an EU member state, it can be freely marketed in any EU country.
It is also important to remember, that manufacturers must have a Quality Management System (QMS). A popular choice is the ISO 13485 certification. Such certification is valid for three years, in opposition to all other EU licenses, which are valid for five years.
Regarding how long it takes to register a medical device in Portugal depends on the class of the device. The least potentially dangerous device, Class 1 medical device, will usually take the least amount of time to register. In the case of Class III medical devices this process can be significantly longer.
For all manufacturers not registered in the EU, they are required to appoint an Authorized Representative (AR), which will assist with all the details regarding the registration process in their domestic country.
Medical device registrations in Portugal can also be submitted online. INFARMED has developed their own registration system in which manufacturers or Authorized Representatives can register their devices.
All medical devices in Portugal must have the following information placed on their labels:
- Instructions for use
- Batch number (if applicable)
- Deadline for safe use (if applicable)
- Information allowing to identify given medical device and its content
- Best storage conditions
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