{"id":20871,"date":"2022-04-29T12:30:47","date_gmt":"2022-04-29T10:30:47","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20871"},"modified":"2022-04-29T12:30:47","modified_gmt":"2022-04-29T10:30:47","slug":"brazil-udi-system-deadlines-software-as-medical-devices-requirements-samd","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/04\/29\/brazil-udi-system-deadlines-software-as-medical-devices-requirements-samd\/","title":{"rendered":"BRAZIL: UDI\u2019s system deadlines and Software as Medical Devices requirements (SaMD)"},"content":{"rendered":"\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/04\/brasile-sistema-udi-dispositivi-medici-nuovi-requisiti-samd-1024x523.jpg\" alt=\"BRAZIL: UDI\u2019s systema deadlines and Software as Medical Devices requirements (SaMD)\" class=\"wp-image-20852\"\/><figcaption>BRAZIL: UDI\u2019s systema deadlines and Software as Medical Devices requirements (SaMD)<\/figcaption><\/figure>\n\n\n\n<p><strong>RDC Resolution No. 591\/2021<\/strong> <strong>came into force<\/strong> on 10\nJanuary 2022. It requires medical devices regulated by ANVISA &#8211; the Brazilian\nRegulatory Authority &#8211; to be identified using the <strong>UDI<\/strong> (Unique Device\nIdentification) <strong>system<\/strong>.<\/p>\n\n\n\n<p>The resolution applies to all Medical Devices, <strong>except\nfor<\/strong> custom-made Medical Devices and Medical Devices intended for clinical\ninvestigations.<\/p>\n\n\n\n<p><strong>RDC 657\/2022<\/strong> resolution on regulatory requirements\napplicable to <strong>software as Medical Devices (SaMD)<\/strong> which will come<strong> into\nforce in July 2022<\/strong> was published on 24 March.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>UDI\nsystem: different risk classes, different transition periods<\/strong><\/h2>\n\n\n\n<p><strong>Before marketing<\/strong> a Medical Devices on the Brazilian market, it\nis now necessary for the Manufacturer to appoint a <strong>UDI code<\/strong> by placing\nit on the label and, when required, on all levels of packaging.<\/p>\n\n\n\n<p>Please note that the UDI is the code composed\nof numeric or alphanumeric characters that allows the unambiguous\nidentification of a specific device on the market.<\/p>\n\n\n\n<p>As from 10 January 2022, the date of entry into force of CPR No. 591\/2021, ANVISA has provided the following <strong>transitional periods<\/strong> for the <strong>allocation<\/strong> and <strong>application<\/strong> of the <strong>UDI<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>2\u00bd years for Class IV medical devices<\/li><li>3 years for Class III medical devices <\/li><li>4 years for Class II medical devices <\/li><li>6 years for Class I medical devices. <\/li><\/ul>\n\n\n\n<p>For <strong>reusable devices<\/strong> in which the UDI\ninformation is also placed on the product itself, an additional two years are\nadded to the transition period indicated above for the respective risk class\nfor the fulfilment of requirements.<\/p>\n\n\n\n<p>Only for certain types of medical devices\nmanufactured after 20 June 2020, such as <strong>coronary stents<\/strong>, <strong>drug<\/strong>&#8211;<strong>eluting\ncoronary stents and hip and knee arthroplasty implants<\/strong>, the inclusion of\nthe UDI code in the traceability labels mandatory as of 10 January 2022, when\nthis Resolution came into force.<\/p>\n\n\n\n<p>For the <strong>submission of information to the UDI\ndatabase<\/strong> and the transmission of <strong>UDI information on adverse<\/strong> <strong>event\nnotifications, complaints and field actions<\/strong>, the transitional period,\nreferred to above, will begin when ANVISA will publish the Normative\nInstruction (NI) to declare that the Agency&#8217;s UDI database can receive UDI\ninformation. At the moment ANVISA has not yet stated when the Normative\nInstruction will be published.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>New\nregistration rules for software as a Medical Device (SaMD)<\/strong><\/h2>\n\n\n\n<p><strong>RDC 657\/2022<\/strong> Resolution published by ANVISA on 24 March\n2022 focuses instead on the <strong>new requirements<\/strong> for the <strong>registration<\/strong>\nof <strong>software as Medical Devices<\/strong> (<strong>SaMD<\/strong>), for which the Brazilian\nRegulatory Authority had not previously issued specific rules.<\/p>\n\n\n\n<p>Such requirements will come into force on <strong>1\nJuly 2022<\/strong>.<\/p>\n\n\n\n<p>SaMD products registered with ANVISA will be\nsubject to review, market monitoring, surveillance, and inspections by the\nRegulatory Authority. Furthermore, classification requirements established by\nRDC 185\/2001 will also apply to SaMD.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Exceptions\nof SaMD to which the regulation does NOT apply<\/strong><\/h2>\n\n\n\n<p>RDC 657\/2022 <strong>does not apply<\/strong> to certain\ncategories of SaMD, such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Software\nfor well-being of users<\/li><li>SaMD\nalready listed by ANVISA as a non-regulated product<\/li><li>Software\nused only for administrative and financial purposes within healthcare\norganizations<\/li><li>Software\nused to process demographic and epidemiological medical data without providing\nany diagnostic or therapeutic function<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Is Brazil\na country in which you market your Medical Devices?<\/strong><\/h2>\n\n\n\n<p>Thema\u2019s experts are at your disposal to provide information on how to market your Medical Devices in Brazil, including the implementation of MDSAP. <strong><a rel=\"noreferrer noopener\" aria-label=\"Contact our Costumer Service  (si apre in una nuova scheda)\" href=\"mailto:sales@thema-med.com\" target=\"_blank\">Contact our Costumer Service<\/a><\/strong><a rel=\"noreferrer noopener\" aria-label=\"Contact our Costumer Service  (si apre in una nuova scheda)\" href=\"mailto:sales@thema-med.com\" target=\"_blank\"> <\/a>to request a <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"consultation (si apre in una nuova scheda)\">consultation<\/a><\/strong>!<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/in.gov.br\/en\/web\/dou\/-\/resolucao-rdc-n-591-de-21-de-dezembro-de-2021-370622845\">DRC No. 591\/2021, ANVISA, 21\nDecember 2021<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/resolucao-de-diretoria-colegiada-rdc-n-657-de-24-de-marco-de-2022-389603457\">DRC 657\/2022, ANVISA, 24 March 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>RDC Resolution No. 591\/2021 came into force on 10 January 2022. It requires medical devices regulated by ANVISA &#8211; the Brazilian  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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":[1],"tags":[],"class_list":["post-20871","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRAZIL: UDI\u2019s system deadlines and SaMD requirements<\/title>\n<meta name=\"description\" content=\"Medical Devices in Brazil: new ANVISA resolutions to regulate the UDI system and software as a Medical Device (SaMD)\" \/>\n<meta name=\"robots\" content=\"index, follow, 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