Chile's ISP Opens Public Consultation on National Technovigilance System Guidance for Medical Devices
核心洞察
Chile's Public Health Institute launched a public consultation on August 27, 2026, on a draft Guidance updating post-market surveillance for medical devices and in vitro diagnostics.
The Guidance sets strict reporting timelines, including two business days for sentinel events and three business days for recalls linked to death or permanent impairment.
Manufacturers, importers, and distributors must appoint a Technovigilance Officer in Chile and maintain traceability records across the product lifecycle.
The Chilean Public Health Institute (搜索) (ISP) launched a public consultation on August 27, 2026, on a document titled "Guidance on the National Technovigilance System," which is intended to replace previous editions and update the operational post-market surveillance framework for all medical devices (MDs) and in vitro diagnostic medical devices (IVDMDs) manufactured, imported, or distributed in Chile.
The Guidance aims 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. The consultation will remain open for comments through the designated submission form until September 27, 2026.
Scope Covers Entire Domestic Market
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. It reiterates that the Technovigilance System applies to all MDs and IVDMDs available on the domestic market, whether manufactured, imported, or distributed in Chile.
New Obligations for Industry
For manufacturers, importers, and distributors, the Guidance establishes several core requirements. Companies must formally appoint a Technovigilance Officer and an alternate, both of whom must have a contractual relationship and perform their duties in Chile, and must notify the ISP of their appointment and any subsequent changes.
Firms are also required to implement procedures to collect, retain, and analyze complaints, events, incidents, FSCAs, and technical information throughout the product lifecycle, and to maintain records identifying the product, batch or serial number, manufacturer, and customer or acquiring healthcare provider.
Tiered Reporting Deadlines
Reporting is to be submitted through the Integrated Surveillance System, with deadlines scaled to event severity. Sentinel events must be reported immediately and no later than within two business days. Adverse events must be reported within ten business days, while adverse incidents showing an increase in occurrence must be reported within twenty business days after the trend has been validated.
Upon becoming aware of a sentinel event, companies must initiate an assessment, coordinate with customers and the manufacturer, and respond to the ISP. The Guidance recommends submitting initial, interim, and final responses within 20, 40, and 60 business days, respectively.
Field Safety Actions and Recalls
For FSCAs and market recalls, companies must notify the ISP using form ANDIM/012 and, simultaneously, notify customers through a Field Safety Notice in Spanish. The general reporting deadline is ten business days; however, recalls and certain actions associated with death or permanent impairment and a high probability of occurrence must be reported within three business days.
The Guidance also requires retention of acknowledgements of receipt, investigation records, risk assessments, distribution records, and reconciliation records for recalled units. The ISP may require annual reports for specific MDs and/or IVDMDs.
Administrative Status
The Guidance states in its preamble that it constitutes an administrative document without the force of law. Accordingly, the ISP reserves the authority to request additional information and to establish requirements not expressly described in the Guidance.