F. S. Gettig, N. E. Romero, S. G. Riffel, C. E. Bonell & D. O. Kadur El Ainie
Abstract
This study examines the current state of medical device post-market surveillance (technovigilance) in Argentina, Brazil and Colombia. International regulatory bodies emphasize robust systems for monitoring medical products to minimize incidents. While advanced regulatory systems exist in the U.S. and Europe, published information on adverse event data in Latin America is limited. This research addresses this gap by reviewing the regulatory frameworks, competent authorities, reporting systems, event types, reporting entities, timelines, and public data access in the selected countries. A comparative analysis highlights variations in reporting, data accuracy, standardization, and access to detailed individual adverse event reports. The findings underscore the need for improved education and training to foster consensus on regulations and guidelines, ultimately enhancing medical device safety in the region.