{"id":7586,"date":"2022-01-26T11:49:58","date_gmt":"2022-01-26T14:49:58","guid":{"rendered":"https:\/\/passarini.com.br\/resolution-of-the-directive-board-rdc-432-anvisa-2\/"},"modified":"2022-01-26T13:40:14","modified_gmt":"2022-01-26T16:40:14","slug":"udi-for-brazil-anvisa","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/udi-for-brazil-anvisa\/","title":{"rendered":"UDI for Brazil &#8211; ANVISA"},"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\/2020\/10\/1920x500_informativos_noticias-1.webp\" alt=\"NEWLESTTER\" width=\"1920\" height=\"500\" class=\"wp-image-7069\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.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><span style=\"color: #000000;\"><strong>UDI for Brazil &#8211; ANVISA<\/strong><\/span><\/h2>\n<p>Published on December 29th, 2021, and effective as of January 10, 2022, <strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">ANVISA<\/a><\/span><\/strong> informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil.<\/p>\n<p>The UDI is composed of the UDI-DI (DI = Device Identifier) and the UDI-PI (PI = Production Identifier).<\/p>\n<p>UDI-DI: Unique numeric or alphanumeric code, specific to a device model, which is also used as an &#8220;access key&#8221; to information stored in a UDI database.<\/p>\n<p>UDI-PI: Numerical or alphanumeric code that identifies the device&#8217;s production unit. The different UDI-PI types include one or more of the following information: serial number, batch number, version (for Software as a Medical Device &#8211; SaMD), date of manufacture, and expiration date.<\/p>\n<p>The measure is part of a worldwide trend to improve the traceability and safety of our medical devices.<\/p>\n<p>The implementation deadlines are already defined, based on the risk class of each product*. Please see below:<\/p>\n<ul>\n<li>2.5 years for risk class IV medical devices.<\/li>\n<li>3 years for risk class III medical devices.<\/li>\n<li>4 years for risk class II medical devices.<\/li>\n<li>6 years for risk class I medical devices.<\/li>\n<\/ul>\n<p>*Some products are treated exceptionally and may have a different deadline\/condition for implementation.<\/p>\n<\/div><div class=\"fusion-image-element in-legacy-container\" style=\"--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);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"1366\" height=\"445\" alt=\"udi anvisa\" title=\"quite_the_post_anivisa_udi_FINAL\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final.jpg\" class=\"img-responsive wp-image-7595\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final-200x65.jpg 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final-400x130.jpg 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final-600x195.jpg 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final-800x261.jpg 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final-1200x391.jpg 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/01\/quite-the-post-anivisa-udi-final.jpg 1366w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-2\"><p>The UDI must be generated by an issuing agency.<\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini<\/strong><\/span> can support you in understanding and implementing the UDI in your labeling.<\/p>\n<p>For more <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/en\/services\/\">information<\/a><\/strong><\/span> and explanations about it, send us an e-mail:\u00a0<strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/span><\/strong><\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/p>\n<p>Published: 01\/26\/2022<\/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=\"Passarini Group\" data-description=\"UDI for Brazil - ANVISA\r\nPublished on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil.\r\n\r\nThe UDI is composed of the UDI-DI (DI\" data-link=\"https:\/\/passarini.com.br\/en\/udi-for-brazil-anvisa\/\"><h4 class=\"tagline\" style=\"color:#333333;\">To share<\/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%2Fudi-for-brazil-anvisa%2F&amp;t=Passarini%20Group\" target=\"_blank\" rel=\"noreferrer\" title=\"Facebook\" aria-label=\"Facebook\" data-placement=\"top\" 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href=\"mailto:?subject=Passarini%20Group&amp;body=https%3A%2F%2Fpassarini.com.br%2Fen%2Fudi-for-brazil-anvisa%2F\" target=\"_self\" title=\"Email\" aria-label=\"Email\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Email\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-mail awb-icon-mail\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_4 1_4 fusion-one-fourth fusion-column-last\" style=\"--awb-bg-size:cover;width:25%;width:calc(25% - ( ( 4% ) * 0.25 ) );\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-3\"><h3 data-fontsize=\"22\" data-lineheight=\"48\"><strong>Mais not\u00edcias:<\/strong><\/h3>\n<\/div><div class=\"fusion-recent-posts 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":7571,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68,73,200],"tags":[69,70,155,149],"class_list":["post-7586","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","category-cheers","category-health","tag-anvisa-en","tag-brazil","tag-health","tag-regulatory"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/7586","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\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/comments?post=7586"}],"version-history":[{"count":6,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/7586\/revisions"}],"predecessor-version":[{"id":7600,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/7586\/revisions\/7600"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/7571"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=7586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=7586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=7586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}