At the national level, the registration and notification of medical devices with INFARMED is a mandatory step to ensure their legal placement on the Portuguese market.

We provide comprehensive support for the submission of national notifications, including:

• Identification of the legal requirements applicable to the type and class of the device;
• Preparation and submission of the documentation required by INFARMED, in accordance with current deadlines and formats;
• Support with the notification of medical devices and in vitro diagnostic medical devices;
• Follow-up in cases of product changes, range extensions, or updates to manufacturer data;
• Assistance to national importers and distributors regarding their specific obligations.

This service is particularly relevant for:

• Companies intending to place devices on the Portuguese market;
• National or foreign manufacturers with an Authorised Representative in Portugal;
• Distributors and importers subject to notification with INFARMED.