{"id":12972,"date":"2025-10-28T16:03:57","date_gmt":"2025-10-28T19:03:57","guid":{"rendered":"https:\/\/passarini.com.br\/devices-medical-new-export-route\/"},"modified":"2025-10-28T17:48:37","modified_gmt":"2025-10-28T20:48:37","slug":"anvisa-automates-afe-ae-end-of-waiting","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-automates-afe-ae-end-of-waiting\/","title":{"rendered":"ANVISA Revolution: AFE and AE Are Now Automatic!"},"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:left center;--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-top:0px;--awb-margin-bottom:0px;--awb-flex-wrap:wrap;\" ><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-padding-top:0px;--awb-padding-right:0px;--awb-padding-bottom:0px;--awb-padding-left:0px;--awb-bg-size:cover;--awb-margin-bottom:0px;\"><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%;\"><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\/2018\/01\/1920x500_informativos_noticias-3.webp\" alt=\"newsletter passarini\" width=\"1920\" height=\"500\" class=\"wp-image-7421\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2018\/01\/1920x500_informativos_noticias-3.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-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:10px;--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_3_4 3_4 fusion-three-fourth fusion-column-first\" style=\"--awb-bg-size:cover;width:75%;width:calc(75% - ( ( 4% ) * 0.75 ) );margin-right: 4%;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2 class=\"headingpostinterno\">The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil\u2019s Regulatory Routine<\/h2>\n<div class=\"x_elementToProof\">\n<p>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 as pharmaceuticals, medical devices, cosmetics, and sanitizing products. Historically, the waiting time for the issuance of these certificates \u2014 even after approval \u2014 has been a bottleneck directly impacting companies\u2019 time-to-market.<\/p>\n<p>In a move that marks a significant step forward in Digital Transformation and Bureaucracy Reduction, <a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">ANVISA<\/a> has announced that the issuance of AFE and AE certificates will now be carried out automatically through the Solicita system. This change represents a true revolution in the relationship between the regulated sector and the Agency, eliminating manual intervention in the issuance process and ushering in a new era of agility.<\/p>\n<h3>The Impact of Automation on Your Business<\/h3>\n<p>Automatic issuance is more than a technological upgrade \u2014 it\u2019s a strategic factor for improving predictability and operational efficiency.<\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-content-boxes content-boxes columns row fusion-columns-1 fusion-columns-total-3 fusion-content-boxes-1 content-boxes-icon-with-title content-left\" style=\"--awb-hover-accent-color:#3bafbf;--awb-circle-hover-accent-color:#3bafbf;--awb-item-margin-bottom:40px;\" data-animationOffset=\"top-into-view\"><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-1 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">1. Immediate Agility and Predictability:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>From now on, as soon as a process for granting or amending an AFE\/AE is completed and approved, the certificate will be generated by the Solicita system within minutes. This is a drastic improvement compared to the previous timelines, which depended on manual verification and signing steps. For companies, this means that operations can start or expand almost instantly after regulatory approval.<\/p>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-2 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">2. Error Reduction and Legal Security:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>Automating the issuance process minimizes the risk of human error in generating the final document. Additionally, ANVISA has implemented robust security mechanisms \u2014 including validation via QR Code, Issue Date, Code, and Hash \u2014 all available on the external consultation portal. This transparency and ease of validation strengthen the document\u2019s legal reliability.<br \/>\nHowever, it is crucial that the submission process (the prerequisite for issuance) be impeccable and aligned with the company\u2019s data, as the automatically generated certificate will precisely reflect the approved information in the system.<\/p>\n<\/div><\/div><\/div><div style=\"--awb-backgroundcolor:rgba(255,255,255,0);\" class=\"fusion-column content-box-column content-box-column content-box-column-3 col-lg-12 col-md-12 col-sm-12 fusion-content-box-hover content-box-column-last content-box-column-last-in-row\"><div class=\"col content-box-wrapper content-wrapper link-area-box content-icon-wrapper-yes icon-hover-animation-fade\" data-animationOffset=\"top-into-view\"><div class=\"heading icon-left\"><h2 class=\"content-box-heading fusion-responsive-typography-calculated\" style=\"--h2_typography-font-size:22px;--fontSize:22;line-height:1.25;\">3. The Focus on Perfect Compliance:<\/h2><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"content-container\">\n<p>The key takeaway from this change is that agility applies only to the issuance stage \u2014 not to the petition review itself. With the \u201cend of the waiting line\u201d for certificate generation, the focus now shifts even more toward the quality and compliance of the original petition. Any errors or inconsistencies in company registration or documentation will delay approval, preventing automatic certificate issuance. Excellence in data accuracy and submission quality is now more critical than ever to fully benefit from this new agility.<\/p>\n<\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"400\" height=\"500\" alt=\"ANVISA: Automatic Issuance of AFE and AE via Solicita | Impact and Opportunities\" title=\"Feed &#8211; NOT\u00cdCIA &#8211; Passarini Group 2_AFE_AE_EN copiar\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-400x500.webp\" class=\"img-responsive wp-image-12982\" 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, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-800x1000.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar-819x1024.webp 819w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/10\/Feed-NOTICIA-Passarini-Group-2_AFE_AE_EN-copiar.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 400px\" \/><\/span><\/div><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<h3>Passarini Group: Your Partner in the ANVISA 4.0 Era<\/h3>\n<p>This ANVISA initiative reflects Brazil\u2019s commitment to regulatory modernization. For companies looking to enter or strengthen their position in the Brazilian market, having a strategic partner who understands this new regulatory dynamic is essential.<\/p>\n<p>Passarini Group is at the forefront of monitoring these transformations. Our team is fully prepared to ensure that your AFE and AE petitions (and all subsequent processes) are submitted with the precision required to take full advantage of automation efficiency.<\/p>\n<p>Don\u2019t waste time on bureaucracy \u2014 focus on scaling your business.<\/p>\n<p>Contact our experts today and get your company ready for ANVISA\u2019s new pace!<\/p>\n<p><strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/p>\n<\/div>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-stacked\" style=\"background-color:#f6f6f6;--awb-separator-border-sizes:0px;--awb-layout:row;--awb-alignment-small:space-between;--awb-stacked-align-small:center;\" data-title=\"The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil\u2019s Regulatory Routine\" data-description=\"The End of Waiting: ANVISA Automates AFE and AE, Transforming Brazil\u2019s Regulatory Routine\r\n\r\n\r\nThe 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 as pharmaceuticals, medical devices, cosmetics,\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-automates-afe-ae-end-of-waiting\"><h4 class=\"tagline\" style=\"color:#333333;\">Compartilhar<\/h4><div class=\"fusion-social-networks sharingbox-shortcode-icon-wrapper sharingbox-shortcode-icon-wrapper-1 boxed-icons\"><span><a 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":12982,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67],"tags":[353,354,69,355,356,357,358,359,360,361,362,363,364,203,365,366],"class_list":["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"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12972","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/users\/16"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=12972"}],"version-history":[{"count":7,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12972\/revisions"}],"predecessor-version":[{"id":12988,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12972\/revisions\/12988"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/12982"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=12972"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=12972"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=12972"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}