{"id":18969,"date":"2021-09-21T10:01:53","date_gmt":"2021-09-21T08:01:53","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=18969"},"modified":"2023-01-25T17:12:36","modified_gmt":"2023-01-25T16:12:36","slug":"brazil-anvisa-kicks-off-to-udi-system-for-medical-devices","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2021\/09\/21\/brazil-anvisa-kicks-off-to-udi-system-for-medical-devices\/","title":{"rendered":"BRAZIL: ANVISA, kicks off to UDI system for Medical Devices"},"content":{"rendered":"\r\n<p>At the end of June 2021, the Brazilian Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (<strong>ANVISA<\/strong>) presented new details on the <strong>next UDI system<\/strong> on <strong>Medical Devices <\/strong>in a <strong>motion<\/strong> (Consulta Publica 1051\/2021).<\/p>\r\n\r\n\r\n\r\n<p>In this document, ANVISA suggests <strong>different deadlines<\/strong> to allow <strong>Medical Devices Manufacturers<\/strong> to <strong>conform<\/strong> to <strong>UDI<\/strong> requirements, fundamental to boost Medical Devices traceability and monitoring in the Brazil market.<\/p>\r\n\r\n\r\n\r\n<figure class=\"wp-block-image\"><img decoding=\"async\" class=\"wp-image-18963\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/09\/brasile-anvisa-sistema-udi-dispositivi-medici-1024x536.jpg\" alt=\"Brazil ANVISA kicks off to UDI system for medical devices\" \/>\r\n<figcaption>ANVISA, kicks off to UDI system for medical devices<\/figcaption>\r\n<\/figure>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>What about the deadlines for the Manufacturers?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Deadlines depend on the issuing date of the <strong>final UDI regulation,<\/strong> scheduled for December 2021, and the <strong>devices risk class.<\/strong> The draft includes:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li><strong>2 years<\/strong> for <strong>Class IV<\/strong> devices (highest risk).<\/li>\r\n<li><strong>3 years<\/strong> for <strong>Class III<\/strong> devices (high risk).<\/li>\r\n<li><strong>4 years<\/strong> for <strong>Class II<\/strong> devices (moderate risk).<\/li>\r\n<li><strong>6 years<\/strong> for <strong>Class I<\/strong> devices (low risk).<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>Involved parties have time to send their feedback on the proposal until<strong> November 2021. <\/strong>After that, ANVISA will examine feedbacks received before issuing UDI final regulation. In the event that this timing is confirmed, for example, the deadline Class IV Medical Devices Manufacturers would be <strong>December 2023<\/strong>.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>UDI Database<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>ANVISA foresees as well to establish its own <strong>UDI database<\/strong> in which Manufacturers, or their <strong>Brazil Registration Holders (BRH), <\/strong>will upload UDI data required. BRHs will be responsible for guaranteeing that device\u2019s UDI data will be sent to the database before their marketing in Brazil.<\/p>\r\n\r\n\r\n\r\n<p>Furthermore, the submissions to UDI database must include the Global Device Nomenclature (GMDN) codes.<\/p>\r\n\r\n\r\n\r\n<p>For further information on UDI database, it is though necessary to wait the final regulation issuing by ANVISA.<\/p>\r\n\r\n\r\n\r\n<h2 class=\"wp-block-heading\"><strong>Do you need support to market your devices in Brazil?<\/strong><\/h2>\r\n\r\n\r\n\r\n<p>Entrust yourself to Thema experts. Check out the Country Sheet <strong><a href=\"https:\/\/www.thema-med.com\/en\/medical-device-registration-in-brazil\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Medical Device Registration in Brazil (si apre in una nuova scheda)\">Medical Device Registration in Brazil<\/a><\/strong> to get the main information on registration procedure and <strong><a href=\"mailto:sales@thema-med.com\">contact us for a consultation<\/a><\/strong>!<\/p>\r\n\r\n\r\n\r\n<p>We will help you during the entire registration process to market your device in full compliance with Brazilian regulation.<\/p>\r\n\r\n\r\n\r\n<p><em>Source:<\/em><\/p>\r\n\r\n\r\n\r\n<p><a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/consulta-publica-n-1.051-de-28-de-junho-de-2021-329114919\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Consulta Publica 1051\/2021, ANVISA, June 28, 2021<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>At the end of June 2021, the Brazilian Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (ANVISA) presented new details on the next UDI  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23026,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-18969","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRAZIL: ANVISA, kicks off to UDI system for Medical Devices<\/title>\n<meta name=\"description\" content=\"Brazil. 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