{"id":11937,"date":"2024-04-29T11:24:29","date_gmt":"2024-04-29T14:24:29","guid":{"rendered":"https:\/\/passarini.com.br\/challenges-in-the-search-for-equivalent-articles\/"},"modified":"2024-07-03T16:43:42","modified_gmt":"2024-07-03T19:43:42","slug":"deadline-for-udi-to-comply-with-anvisa-is-approaching-2","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/deadline-for-udi-to-comply-with-anvisa-is-approaching-2\/","title":{"rendered":"UDI: How to Prepare for ANVISA&#8217;s Regulatory Changes in Medical Devices"},"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=\"Banner Informativos Blog da Passarini\" width=\"1560\" height=\"406\" class=\"wp-image-8654\" \/><\/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 deadline for UDI to comply with ANVISA is approaching<\/h2>\n<p>With the publication of RDC (Collegiate Board Resolution) No. 591\/2021, ANVISA established the requirement to identify medical devices in its regulated products using the UDI (Unique Device Identification) system.<\/p>\n<p>The UDI is the set of codes formed by the DI (Device Identifier) + PI (Production Identifier).<\/p>\n<p>The implementation of UDI in Brazil is based on a global strategy that prioritizes the promotion of patient safety through improved traceability, efficiency and management of devices in the supply chain.<\/p>\n<p>The first regulatory agency to adopt UDI was the FDA (Food and Drug Administration), starting in September 2013, and since December 2022 it has required all classes of devices to have this identification. In Europe, it was already mentioned in 2017 in MDR 2017\/745 and since 2022 the database has been ready for registration.<\/p>\n<p>ANVISA&#8217;s UDI registration database has not yet been released, but this will not be a reason not to implement it. After the deadline set in the RDC, manufacturers will not be able to market devices without identification.<\/p>\n<p>The risks of a lack of UDI can lead to sanitary infractions, resulting in the suspension of the marketing, import and\/or use of the medical device. The resolution came into force on January 10, 2022 and the deadlines for adapting the UDI in products registered and marketed by ANVISA are:<\/p>\n<\/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 awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><strong>07\/2024<\/strong> for risk class IV medical devices<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><strong>01\/2025<\/strong> for risk class III medical devices<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><strong>01\/2026<\/strong> for risk class II medical devices<\/p>\n<\/div><\/li><li class=\"fusion-li-item\" style=\"\"><span class=\"icon-wrapper circle-yes\"><i class=\"fusion-li-icon awb-icon-check\" aria-hidden=\"true\"><\/i><\/span><div class=\"fusion-li-item-content\">\n<p><strong>01\/2028<\/strong> for risk class I medical devices<\/p>\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;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-2\"><p>The UDI is the sequence of characters that identifies a device on the country&#8217;s market and must be presented in a machine-readable (MR) and human-readable (HR) format.<\/p>\n<p>This identification must be located on the device or on its own packaging and each higher level of packaging must contain its own UDI. It is generated by an issuing agency and is presented as follows:<\/p>\n<ul>\n<li>UDI-DI: device identification numbers, consisting of the manufacturer and model identification numbers. They are prefixed with \u201c01\u201d.<\/li>\n<li>UDI-PI: the device&#8217;s production identification numbers, such as the expiration and manufacturing date, batch number and serial number. They are prefixed with the numbers (17\u201d, \u201c11\u201d, \u201c10\u201d and \u201c21\u201d, respectively.<\/li>\n<\/ul>\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-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\" id=\"https:\/\/passarini.com.br\/wp-admin\/post.php?post=11937&amp;action=edit&amp;lang=en#\"><a href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT.webp\" class=\"fusion-lightbox\" data-rel=\"iLightbox[UDI]\" data-caption=\"identifica unicamente o dispositivo\" data-title=\"BLOG_meio_do_post_anivisa_udi_PT\" title=\"BLOG_meio_do_post_anivisa_udi_PT\"><img decoding=\"async\" width=\"300\" height=\"98\" alt=\"identifica unicamente o dispositivo\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-300x98.webp\" class=\"img-responsive wp-image-11945\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-200x65.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-300x98.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-400x130.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-600x195.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-768x250.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-800x261.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-1024x334.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT-1200x391.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/04\/BLOG_meio_do_post_anivisa_udi_PT.webp 1366w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/a><\/span><\/div><\/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-text fusion-text-3\"><p>The process of implementing UDI may seem complex, but Passarini Group is ready to help you. We are available to assist you, just contact us by e-mail: <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br?subject=Enquadramento%20de%20porte%20ANVISA\">contato@passarini.com.br<\/a><\/strong>.<\/span><\/p>\n<h2><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/h2>\n<p>Published on: 04\/29\/2024<\/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=\"The deadline for UDI to comply with ANVISA is approaching\r\nWith the publication of RDC (Collegiate Board Resolution) No. 591\/2021, ANVISA established the requirement to identify medical devices in its regulated products using the UDI (Unique Device Identification) system.\r\n\r\nThe UDI is the set of codes formed by the DI (Device Identifier)\" data-link=\"https:\/\/passarini.com.br\/en\/?p=11937\"><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%2F%3Fp%3D11937&amp;t=Passarini%20Group\" 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;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/x.com\/intent\/post?text=Passarini%20Group&amp;url=https%3A%2F%2Fpassarini.com.br%2Fen%2F%3Fp%3D11937\" target=\"_blank\" rel=\"noopener 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":11956,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,216],"tags":[69,219],"class_list":["post-11937","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-regulatorios-en","tag-anvisa-en","tag-udi-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11937","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=11937"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11937\/revisions"}],"predecessor-version":[{"id":11960,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11937\/revisions\/11960"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/11956"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=11937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=11937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=11937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}