{"id":1221,"date":"2025-10-16T12:33:22","date_gmt":"2025-10-16T15:33:22","guid":{"rendered":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/?p=1221"},"modified":"2025-10-20T13:15:08","modified_gmt":"2025-10-20T16:15:08","slug":"medical-devices-post-market-monitoring-current-status-in-latin-america","status":"publish","type":"post","link":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/2025\/10\/16\/medical-devices-post-market-monitoring-current-status-in-latin-america\/","title":{"rendered":"Medical Devices Post Market Monitoring: Current Status in Latin America"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"1221\" class=\"elementor elementor-1221\">\n\t\t\t\t<div class=\"elementor-element elementor-element-614a8a7c e-flex e-con-boxed e-con e-parent\" data-id=\"614a8a7c\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6b182f79 elementor-widget elementor-widget-text-editor\" data-id=\"6b182f79\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\n<h5 class=\"wp-block-heading\"><a href=\"https:\/\/www.linkedin.com\/in\/florencia-gettig-a51213254\/\">F. S. Gettig<\/a>, <a href=\"https:\/\/www.linkedin.com\/in\/nazarena-romero-365b22325\/\">N. E. Romero<\/a>, <a href=\"https:\/\/www.linkedin.com\/in\/sheila-gabriela-riffel-a8714b375\/\">S. G. Riffel<\/a>,\u00a0<a href=\"https:\/\/www.linkedin.com\/in\/claudia-edith-bonell-ab41896\/\">C. E. Bonell<\/a>\u00a0&amp;\u00a0 <a href=\"https:\/\/www.linkedin.com\/in\/diego-kadur-96125b39\/\">D. O. Kadur El Ainie<\/a><\/h5>\n<h3 id=\"Abs1\" class=\"c-article-section__title js-section-title js-c-reading-companion-sections-item\">Abstract<\/h3>\n\n<p>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.<\/p>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2bf59fb e-flex e-con-boxed e-con e-parent\" data-id=\"2bf59fb\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-9f1569c elementor-widget elementor-widget-button\" data-id=\"9f1569c\" data-element_type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/link.springer.com\/chapter\/10.1007\/978-3-032-06401-1_46\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Acceder al art\u00edculo completo<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>F. S. Gettig, N. E. Romero, S. G. Riffel,\u00a0C. E. Bonell\u00a0&amp;\u00a0 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. [&hellip;]<\/p>\n","protected":false},"author":5,"featured_media":1225,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[],"class_list":["post-1221","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-publicaciones"],"_links":{"self":[{"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/posts\/1221","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/comments?post=1221"}],"version-history":[{"count":12,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/posts\/1221\/revisions"}],"predecessor-version":[{"id":1238,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/posts\/1221\/revisions\/1238"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/media\/1225"}],"wp:attachment":[{"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/media?parent=1221"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/categories?post=1221"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/ingenieria.uner.edu.ar\/nucleos\/licis\/index.php\/wp-json\/wp\/v2\/tags?post=1221"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}