{"id":12458,"date":"2025-04-02T16:20:23","date_gmt":"2025-04-02T19:20:23","guid":{"rendered":"https:\/\/passarini.com.br\/inmetro-seal-importance-mandatory-2\/"},"modified":"2025-04-03T14:15:45","modified_gmt":"2025-04-03T17:15:45","slug":"anvisa-public-consultation-udi-requirements","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-public-consultation-udi-requirements\/","title":{"rendered":"Anvisa: Public Consultation on UDI for 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>Anvisa Opens Public Consultation on UDI: Understand the New Requirements for Medical Devices<\/h2>\n<p><a href=\"https:\/\/en.wikipedia.org\/wiki\/Brazilian_Health_Regulatory_Agency\">The Brazilian Health Regulatory Agency<\/a> (Anvisa) has announced the opening of a public consultation to gather contributions regarding the requirements for the transmission and management of the Brazilian Unique Device Identification (UDI) database for medical devices. The initiative aims to enhance regulation and ensure the safety and traceability of medical devices marketed in Brazil.<\/p>\n<p>The regulation under consultation specifically addresses the proposed normative instruction that defines the basic conditions for submitting UDI data to Anvisa. According to the Agency, the database, named the Unique Device Identification System (SIUD &#8211; Sistema \u00danico de Identifica\u00e7\u00e3o de Dispositivos), is already ready to receive information from companies in the sector.<\/p>\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-text fusion-text-2\"><p>It is crucial to highlight that data submission to SIUD will not be mandatory immediately upon the new normative instruction coming into effect. The deadlines for mandatory transmission comply with the Collegiate Board Resolution (RDC) No. 591\/2021 and will be counted from the effective date of the new regulation.<\/p>\n<p>The public consultation will remain open for a 60-day period, from March 27 to May 26, 2025. During this time, all interested parties, including medical device companies, healthcare professionals, and other stakeholders, can submit their contributions to help shape the regulation.<\/p>\n<p>The implementation of SIUD represents a significant advancement for the safety and traceability of medical devices in the country, enabling more effective control over the circulation of these products in the market. With active public participation in the consultation, Anvisa expects to consolidate a robust and efficient system for medical device identification.<\/p>\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\"><img decoding=\"async\" width=\"300\" height=\"300\" alt=\"Navigate regulations with Passarini Group\" title=\"Website BLOG Passarini_UDI_ANVISA\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-300x300.webp\" class=\"img-responsive wp-image-12463\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-66x66.webp 66w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-150x150.webp 150w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-200x200.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-300x300.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-400x400.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-600x600.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-768x768.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-800x800.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa-1024x1024.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2025\/04\/website-blog-passarini-udi-anvisa.webp 1080w\" sizes=\"(max-width: 800px) 100vw, 300px\" \/><\/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>UDI is an international standard system aimed at ensuring greater transparency and safety in the medical device sector. With the implementation of this system in Brazil, the traceability of medical devices will be enhanced, allowing for more precise identification of products throughout their entire lifecycle, from manufacturing to final use in patients. Furthermore, <a href=\"https:\/\/bit.ly\/4lfnTS1\">SIUD<\/a> can assist in the detection of non-compliant products, preventing risks to public health.<\/p>\n<p>The adoption of UDI will bring significant benefits to the healthcare sector, including greater efficiency in the management of medical devices by hospitals and clinics, easier traceability of products in case of recalls, and a more effective monitoring system by regulatory bodies.<\/p>\n<p>To participate in the public consultation, interested parties should access the Anvisa website and submit their contributions within the stipulated deadline. This is a unique opportunity for the sector to collaborate directly in defining the guidelines that will govern the management and transmission of <a href=\"https:\/\/passarini.com.br\/prazo-para-adequacao-udi-anvisa-esta-proximo\/\">UDI data in Brazil<\/a>. It is essential that manufacturers, importers, distributors, and other interested parties participate actively, ensuring the regulation is aligned with the needs of the market and patient safety.<\/p>\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=\"_self\" href=\"https:\/\/bit.ly\/4lfnTS1\"><span class=\"fusion-button-text awb-button__text awb-button__text--default\">ACCESS THE PUBLIC CONSULTATION<\/span><\/a><\/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-4\"><p>Contact Passarini Group to learn more about how we can assist your company. Send an email to <strong><a href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/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=\"INMETRO Seal: Understand the Importance and Mandatory Nature of Certification\" data-description=\"Anvisa Opens Public Consultation on UDI: Understand the New Requirements for Medical Devices\r\nThe Brazilian Health Regulatory Agency (Anvisa) has announced the opening of a public consultation to gather contributions regarding the requirements for the transmission and management of the Brazilian Unique Device Identification (UDI) database for medical devices. 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":12463,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[251],"tags":[326,323,325,324],"class_list":["post-12458","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-inmetro-en","tag-how-to-obtain-the-inmetro-seal","tag-inmetro-certification","tag-inmetro-certified-products","tag-inmetro-mandatory"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12458","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=12458"}],"version-history":[{"count":3,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12458\/revisions"}],"predecessor-version":[{"id":12469,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/12458\/revisions\/12469"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/12463"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=12458"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=12458"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=12458"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}