REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In Portugal, devices are regulated by the National Authority of Medicines and Health Products, I.P.(Infarmed).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years.
AUTHORIZED REPRESENTATIVE: An authorized representative is required anywhere in the European Union.
ADDITIONAL INFORMATION: On 5 April 2017, 2 new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. These replace the existing Directives. The new rules will only apply after a transitional period. Namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices. The manufacturer of class IIa, IIb, III, implantable active medical devices & IVD Annex II and self-testing in vitro diagnostic medical devices, or his authorized representative which put in service medical devices in Portugal, shall notify the INFARMED, IP.