{"id":1754,"date":"2017-05-30T16:27:18","date_gmt":"2017-05-30T19:27:18","guid":{"rendered":"http:\/\/passarini.com.br\/blog\/"},"modified":"2026-02-12T17:39:05","modified_gmt":"2026-02-12T20:39:05","slug":"blog","status":"publish","type":"page","link":"https:\/\/passarini.com.br\/en\/blog\/","title":{"rendered":"Blog"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 hundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:center top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" id=\"quem-somos-banner-container\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-size:cover;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-slider-sc fusion-flexslider-loading flexslider flexslider-hover-type-none\" data-slideshow_autoplay=\"1\" data-slideshow_smooth_height=\"0\" data-slideshow_speed=\"7000\" style=\"max-width:100%;height:100%;\" id=\"quem-somos-slider\"><ul class=\"slides\"><li class=\"image\"><span class=\"fusion-image-hover-element hover-type-none\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog.webp\" alt=\"blog banner\" width=\"1920\" height=\"500\" class=\"wp-image-7194\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2021\/09\/1920x500_banner_blog.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/li><\/ul><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-padding-top:40px;--awb-padding-bottom:100px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last fusion-column-no-min-height\" style=\"--awb-bg-size:cover;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h1 style=\"text-align: center;\">Passarini Blog<\/h1>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-infinite\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:15px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -15px !important; margin-right:-15px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-infinite fusion-posts-container-load-more fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope fusion-blog-equal-heights\" data-pages=\"14\" data-grid-col-space=\"30\" style=\"margin: -15px -15px 0;min-height:500px;\"><article id=\"blog-1-post-13115\" class=\"fusion-post-grid post-13115 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\" aria-label=\"SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed_post_EN_NOTICIA_story_feed_PASSARINI_SIUD.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\">SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines The medical device sector in Brazil has just taken a historic step towards total traceability. During the 2nd Ordinary Public Meeting of the Collegiate Board (DICOL) in 2026, Anvisa approved the Normative [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13090\" class=\"fusion-post-grid post-13090 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en category-regulatory tag-anvisa-en tag-anvisa-notification tag-anvisa-registration tag-anvisa-regulation tag-anvisa-rejection tag-brazilian-market tag-class-i-products tag-class-ii-products tag-medical-devices tag-passarini-group tag-public-health tag-rdc-751-2022 tag-regulatory-compliance tag-regulatory-consulting\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\" aria-label=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2026\/02\/feed-noticia-passarini-preto_EN_FDA.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\">FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     FDA Publishes New Quality Management System Regulation (QMSR) and Transforms the Regulatory Landscape for Medical Devices The U.S. Food and Drug Administration (FDA) has published the Quality Management System Regulation (QMSR), a significant update to the former Quality System Regulation (QSR) found in 21 CFR [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-13024\" class=\"fusion-post-grid post-13024 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en category-regulatory tag-anvisa-en tag-anvisa-notification tag-anvisa-registration tag-anvisa-regulation tag-anvisa-rejection tag-brazilian-market tag-class-i-products tag-class-ii-products tag-medical-devices tag-passarini-group tag-public-health tag-rdc-751-2022 tag-regulatory-compliance tag-regulatory-consulting\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\" aria-label=\"The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1080\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"The Simplified Process Trap: Why Do Class I and II Products Lead ANVISA Denials?\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-66x66.webp 66w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-150x150.webp 150w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-200x200.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-300x300.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-400x400.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-600x600.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-768x768.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-800x800.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN-1024x1024.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/website-BLOG-Passarini_-classe-1-EN.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\">The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     The Myth of the \"Easy\" Process In the medical device sector, there is a common and mistaken perception that the regulatory process for Class I and II products is simple and quick. Many companies have the false impression that \"it seems easy, but it's not!\". [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-12996\" class=\"fusion-post-grid post-12996 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\/\" aria-label=\"New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"Navigating ANVISA&#039;s new digital scheduling system?\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/11\/Feed-NOTICIA-Passarini-Groupsistema-en-copiar.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\/\">New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     New ANVISA Scheduling System: 3 Compliance Rules You Need to Master (And the 5-Year Record Keeping Risk) The end of the Parlat\u00f3rio and ANVISA's new digital era: Understand how Ordinance 54\/2021 and automation demand Compliance 4.0 to avoid rejections and ensure the legal security of [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-12972\" class=\"fusion-post-grid post-12972 post type-post status-publish format-standard has-post-thumbnail hentry category-anvisa-en tag-ae tag-afe tag-anvisa-en tag-anvisa-automation tag-company-operating-authorization tag-debureaucratization tag-digital-transformation tag-health-surveillance tag-legal-security tag-passarini-group tag-regulatory-compliance tag-regulatory-consulting tag-regulatory-process-brazil tag-solicita-system tag-special-authorization tag-time-to-market\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/anvisa-automates-afe-ae-end-of-waiting\/\" aria-label=\"ANVISA Revolution: AFE and AE Are Now Automatic!\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"ANVISA Automates AFE and AE, Transforming Brazil\u2019s Regulatory Routine\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-768x960.webp 768w, 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and AE Are Now Automatic!<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil\u2019s Regulatory Routine The Authorization to Operate (AFE) and Special Authorization (AE) are foundational documents for any company seeking to operate in a market regulated by the Brazilian Health Regulatory Agency (ANVISA), covering sectors such [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-12638\" class=\"fusion-post-grid post-12638 post type-post status-publish format-standard has-post-thumbnail hentry category-mexico-en-2 category-regulatorios-en tag-medical-devices tag-regulatorio-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,1);border:1px solid #ebeaea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#ebeaea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/passarini.com.br\/en\/devices-medical-new-export-route\/\" aria-label=\"Devices to America: How U.S. Tariffs Are Changing Medical Device Exports\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1080\" height=\"1350\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco.webp\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-200x250.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-240x300.webp 240w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-400x500.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-600x750.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-768x960.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/09\/feed-noticia-passarini-group-2-en-tarifaco.webp 1080w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 370px, (min-width: 732px) 555px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:30px 25px 20px 25px;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/devices-medical-new-export-route\/\">Devices to America: How U.S. Tariffs Are Changing Medical Device Exports<\/a><\/h2><div class=\"fusion-post-content-container\"><p>     The \u201cTarifa\u00e7o\u201d and the Changing Export Routes of Brazilian Medical Devices The term \u201ctarifa\u00e7o\u201d refers to the steep tariffs imposed by the United States on certain imported products \u2014 in this case, Brazilian medical devices \u2014 which increase the cost of direct access to the [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><div class=\"fusion-infinite-scroll-trigger\"><\/div><div class=\"pagination infinite-scroll clearfix\" style=\"display:none;\"><span class=\"current\">1<\/span><a 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