{"id":5045,"date":"2025-05-15T17:41:17","date_gmt":"2025-05-15T17:41:17","guid":{"rendered":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/?post_type=event&#038;p=5045"},"modified":"2025-05-15T17:46:40","modified_gmt":"2025-05-15T17:46:40","slug":"5th-anniversary-session","status":"publish","type":"event","link":"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/coalition-action\/events\/5th-anniversary-session\/","title":{"rendered":"5th Anniversary Session"},"content":{"rendered":"\n<p>The Inter-American Coalition for Regulatory Convergence in the Medical Devices Sector held its 5th Anniversary Session on 8 May 2025. The agenda included a first proposal of the approval times metrics of some countries in the region, as well as the presentation of a tool to consolidate them. Additionally, progress reports from the Working Groups were presented, along with a retrospective of the past five years of the Coalition, besides a review of the Action Plan 2020 &#8211; 2025 as a starting point for the preparation of the 2026 &#8211; 2030 Plan. The meeting was attended by 75 representatives from 8 countries, as shown below.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Country<\/strong><\/td><td><strong>Attendees<\/strong><\/td><\/tr><tr><td>Argentina<\/td><td>5<\/td><\/tr><tr><td>Brazil<\/td><td>23<\/td><\/tr><tr><td>Colombia<\/td><td>3<\/td><\/tr><tr><td>Ecuador<\/td><td>1<\/td><\/tr><tr><td>Mexico<\/td><td>29<\/td><\/tr><tr><td>Peru<\/td><td>4<\/td><\/tr><tr><td>Spain<\/td><td>1<\/td><\/tr><tr><td>United States<\/td><td>9<\/td><\/tr><tr><td><strong>Total<\/strong><\/td><td><strong>75<\/strong><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Agenda<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-5th-Anniversary-Meeting-08May25-Internal-Session-v2.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Recording<\/h2>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/youtu.be\/nFMEOkzr5Ew\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading mb-0 has-accent-color has-text-color has-medium-font-size\">Presentations<\/h2>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>IACRC Metrics for NRA Authorization Timelines &#8211; Sandra Ligia Gonz\u00e1lez, IACRC<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-NRA-Metrics-Final.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Tools for Metrics &#8211; Iv\u00e1n Legazpi, AMID<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Working Groups Updates:<\/strong><\/h5>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>GMPs. Strategies to increase NRAs affiliation to MDSAP &#8211; Duglas Rodrigues Calder\u00f3n, Roche<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-GMP-MDSAP-WG-Strategy-Update_8May25.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Regulatory Reliance. Strategies to leverage resources available at GMTA &amp; Coalition &#8211; Renata Brand\u00e3o, Abbott<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/Reliance-Inter-American-Coalition-5th-Anniversary-may-25.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>CFG &amp; FSC \u2013 Apostille. Strategies to eliminate the requirement &#8211; Renata Brand\u00e3o, Abbott<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/WG-CFG-CFS-Inter-American-Coalition-5th-Anniversary-ma7-25.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>eIFU. Strategies to implement as general practice &#8211; Yenni Cruz, Abbott<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/Working-group-e-IFU-Coalition-08-May-25.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>Open public consultations. Industry active participation &#8211; Magdalena del Sel, J&amp;J<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-WG-Open-Consultations.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>IACRC &#8211; First five years in retrospective<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-WG-Open-Consultations.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading mb-1\" style=\"font-size:16px\"><strong>IACRC Action Plan 2026 \u2013 2030<\/strong><\/h5>\n\n\n\n<div class=\"wp-block-buttons mb-2 is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button justified\"><a class=\"wp-block-button__link has-accent-background-color has-background wp-element-button\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/wp-content\/uploads\/sites\/4\/2025\/05\/IACRC-Action-Plan-2026-2030.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">English<\/a><\/div>\n<\/div>\n","protected":false},"featured_media":0,"parent":0,"template":"","event_category":[11],"class_list":["post-5045","event","type-event","status-publish","hentry","event_category-private","event_category-11","description-off"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>5th Anniversary Session - Regulatory Convergence<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.interamericancoalition-medtech.org\/regulatory-convergence\/coalition-action\/events\/5th-anniversary-session\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"5th Anniversary Session - Regulatory Convergence\" \/>\n<meta property=\"og:description\" content=\"The Inter-American Coalition for Regulatory Convergence in the Medical Devices Sector held its 5th Anniversary Session on 8 May 2025. 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