{"id":12584,"date":"2025-08-07T08:51:56","date_gmt":"2025-08-07T11:51:56","guid":{"rendered":"https:\/\/passarini.com.br\/anvisa-certificate-validity-change-2\/"},"modified":"2025-08-12T11:52:30","modified_gmt":"2025-08-12T14:52:30","slug":"anvisa-rdc-982-2025-risk-management","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-rdc-982-2025-risk-management\/","title":{"rendered":"RDC 982\/2025: What&#8217;s Changing for the Good Practice Certificate?"},"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\">ANVISA Publishes RDC 982\/2025: Understanding the Optimization of Risk Management and Compliance Monitoring<\/h2>\n<div class=\"x_elementToProof\">\n<p>Keeping up with constant regulatory updates is essential for any company in the sector. The Passarini Group highlights the recent publication of ANVISA&#8217;s Collegiate Board Resolution (RDC) No. 982, from July 28, 2025, which arrives to enhance risk management and compliance monitoring processes.<\/p>\n<p>This new resolution does not represent a radical change, but rather an evolution. It optimizes how <a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">ANVISA<\/a> will use health risk management and compliance monitoring criteria for the initial granting or renewal of Good Practice Certificates.<\/p>\n<h3>What Does RDC 982\/2025 Mean for Your Company?<\/h3>\n<p>In essence, the new RDC establishes a more modern and efficient framework for company evaluations. Instead of being a one-time process, risk management and monitoring become more integrated and continuous criteria in the agency&#8217;s decisions. This means that ANVISA will have a more complete and proactive view of each company&#8217;s compliance.<\/p>\n<p>For you, this translates into the need to maintain a robust and up-to-date management system that demonstrates a constant commitment to quality and safety.<\/p>\n<p><strong>Key Points for Your Attention<\/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;margin-top:20px;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><ul style=\"--awb-line-height:23.8px;--awb-icon-width:23.8px;--awb-icon-height:23.8px;--awb-icon-margin:9.8px;--awb-content-margin:33.6px;--awb-circlecolor:#3bafbf;--awb-circle-yes-font-size:12.32px;\" class=\"fusion-checklist fusion-checklist-1 fusion-checklist-default type-icons\"><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"x_elementToProof\" role=\"presentation\"><strong>Does not revoke RDC 497\/2021:<\/strong> It is crucial to note that RDC 982\/2025 does not cancel the previous resolution. It acts as a complement, optimizing the application of risk management and monitoring already provided for in RDC 497\/2021.<\/div>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"x_elementToProof\" role=\"presentation\"><strong>Validity of certificates:<\/strong> The new RDC does not change the validity periods of existing certificates. Therefore, there is no need for immediate concern about the validity of your current documents.<\/div>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon fa-angle-right fas\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<div class=\"x_elementToProof\" role=\"presentation\"><strong>Focus on improvement:<\/strong> ANVISA&#8217;s goal is to make the certification process more assertive and aligned with the best practices of risk management.<\/div>\n<\/div><\/li><\/ul><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><a class=\"awb-lightbox awb-lightbox-1\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/08\/feed-noticia-passarini-group-rdc982-1.webp\" data-rel=\"iLightbox\"><img decoding=\"async\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/08\/feed-noticia-passarini-group-rdc982-1-200x200.webp\" alt=\"ANVISA Publishes RDC 982\/2025: Understanding the Optimization of Risk Management and Compliance Monitoring\"><\/a><div class=\"fusion-text fusion-text-2\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<p>The Passarini Group is attentive to all updates and ready to help your company navigate these changes. Understanding and adapting to these enhancements is crucial to ensuring compliance and success in your <a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/process-validation\/\">regulatory processes<\/a>.<\/p>\n<p>For a complete understanding of the resolution and its implications, the Passarini Group encourages reading the full document. Access Collegiate Board Resolution <strong>(RDC) No. 982\/2025<\/strong> directly to delve deeper into the risk management and monitoring criteria.<\/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-align-block\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"width:calc(100%);\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/07\/RDC_Anvisa_N_982_julho_2025_Passarini_Group.pdf\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">ACCESS RDC No. 982\/2025<\/span><\/a><\/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-3\" style=\"--awb-margin-top:10px;\"><div class=\"x_elementToProof\" data-olk-copy-source=\"MessageBody\">\n<h3>Need Help Adapting to ANVISA&#8217;s New Rules?<\/h3>\n<p>Understand how RDC 982\/2025 can impact your company and ensure a smoother and more secure certification and renewal process.<\/p>\n<p>Contact our team of experts and guarantee your business&#8217;s compliance. Send an email to <strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/strong><\/p>\n<\/div>\n<p><strong>Fly higher with Passarini Group!<\/strong><\/p>\n<\/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=\"RDC 982\/2025: What&#039;s Changing for the Good Practice Certificate?\" data-description=\"ANVISA Publishes RDC 982\/2025: Understanding the Optimization of Risk Management and Compliance Monitoring\r\n\r\n\r\nKeeping up with constant regulatory updates is essential for any company in the sector. The Passarini Group highlights the recent publication of ANVISA&#039;s Collegiate Board Resolution (RDC) No. 982, from July 28, 2025, which arrives to enhance\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-rdc-982-2025-risk-management\"><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 href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fpassarini.com.br%2Fen%2Fanvisa-rdc-982-2025-risk-management&amp;t=RDC%20982%2F2025%3A%20What%27s%20Changing%20for%20the%20Good%20Practice%20Certificate%3F\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Facebook\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-facebook awb-icon-facebook\" style=\"color:#ffffff;background-color:#3b5998;border-color:#3b5998;border-radius:4px;\" 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":12587,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[216],"tags":[153],"class_list":["post-12584","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatorios-en","tag-regulatorio-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12584","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=12584"}],"version-history":[{"count":2,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12584\/revisions"}],"predecessor-version":[{"id":12589,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12584\/revisions\/12589"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/12587"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=12584"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=12584"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=12584"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}