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Medical Device Registration and Approval in Portugal
General country-specific regulatory information is provided on this page for medical device registration and approval in Portugal.
Last updated on November 30th, 2021.
Medical Device Regulations and Classification in Portugal
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.
For detailed device-specific compliance information for each market, including Portugal, to expedite the preparation of your medical device or IVD registration application.
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