New Form for Reporting Adverse Events and Quality Deviations in Medical Devices

New Reporting Form Available

Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT) has announced the availability of a new online form for the reporting of adverse events and quality deviations associated with medical devices. The form is accessible through the official ANMAT portal and replaces previous paper-based or older digital submission channels.

Purpose and Scope

The new form consolidates reporting for both adverse events (technovigilance) and quality deviations into a single submission pathway. It is intended for use by manufacturers, importers, authorized representatives, healthcare professionals, and patients who identify safety signals or quality issues related to medical devices marketed in Argentina.

Objective

ANMAT states that the new reporting mechanism aims to strengthen the national technovigilance system by improving data collection quality, reducing reporting burden, and enabling faster signal detection and regulatory response. The consolidated form supports Argentina's alignment with international post-market surveillance best practices.