ISP Launches Public Consultation On The National Technovigilance System Guidance

On August 27, 2026, the Chilean Public Health Institute (“ISP”) launched a public consultation on the document entitled “Guidance on the National Technovigilance System” (the “Guidance”).

The Guidance is intended to replace previous editions and updates the operational post-market surveillance framework applicable to all medical devices (“MDs”) and in vitro diagnostic medical devices (“IVDMDs”) manufactured, imported, or distributed in Chile. Its purpose is to strengthen the prevention, detection, investigation, and reporting of adverse events and incidents, as well as the management of Field Safety Corrective Actions (“FSCAs”) and recalls.

Scope

The Guidance is addressed to individual and institutional healthcare providers in both the public and private sectors, institutions of the Armed Forces and Public Order and Security Forces, MD manufacturers, importers, and distributors, as well as the general public using such products. The Guidance also reiterates that the Technovigilance