{"id":9444,"date":"2022-09-16T14:00:36","date_gmt":"2022-09-16T17:00:36","guid":{"rendered":"https:\/\/passarini.com.br\/passrod-has-joined-abimed\/"},"modified":"2022-09-16T16:58:45","modified_gmt":"2022-09-16T19:58:45","slug":"anvisa-updates-rules-for-the-regularization-of-medical-devices-in-brazil","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-updates-rules-for-the-regularization-of-medical-devices-in-brazil\/","title":{"rendered":"Anvisa updates rules for the regularization of medical devices in Brazil"},"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\">Anvisa updates rules for RDC n\u00ba 185\/2001 &#8211; regulation of medical devices in Brazil<\/h2>\n<p><a href=\"https:\/\/pt.wikipedia.org\/wiki\/Ag%C3%AAncia_Nacional_de_Vigil%C3%A2ncia_Sanit%C3%A1ria\">Anvisa<\/a> released on its website on Wednesday (14\/09) a news informing about the update of the rules for regularization of medical devices in Brazil.\u00a0According to Anvisa, the Collegiate Board approved the proposal that revises RDC 185\/2001, which is the current legislation.<\/p>\n<p>The <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2022\/anvisa-atualiza-regras-para-regularizacao-de-dispositivos-medicos-no-brasil\">new RDC<\/a> has not yet been published, but Anvisa has already advanced some changes that will appear in the text of the new RDC, as follows:<\/p>\n<p>\u201cThe new text promotes the internalization of Mercosur GMC Resolution No. 25\/2021, which, at the initiative of Brazil, updated the documentary requirements and classification rules for medical devices applicable to the region. In addition to the internalization of the standard, the text consolidates a series of other regulations issued by Anvisa that deal with the process of regularization of medical devices.<\/p>\n<p>Highlights of the new text are:<\/p>\n<ul>\n<li>Adoption of specific classification rules for new technologies, such as Software as Medical Device and nanomaterials;<\/li>\n<li>Consolidation of rules for notification, registration and changes in a single RDC;<\/li>\n<li>Incorporation of rules for the Documentary Repository of Medical Devices;<\/li>\n<li>Incorporation of rules on Instructions for Use in non-printed format;<\/li>\n<li>Adoption of the Table of Contents structure (IMDRF&#8217;s Table of Contents) for Technical Dossiers, enabling the use of dossiers prepared for multiple jurisdictions (regulatory convergence);<\/li>\n<li>Prediction of situations for depletion of finished products, packaging, labels and instructions for use;<\/li>\n<li>Formalization of the procedural reassessment procedure; and<\/li>\n<li>General modernization of the text and updating of terminology.<\/li>\n<\/ul>\n<p>The new RDC will take effect on <strong>March 1, 2023<\/strong>, in order to allow the productive sector to make the necessary adjustments in its future petitions to Anvisa\u201d.<\/p>\n<p>Stay tuned on our <a href=\"https:\/\/passarini.com.br\/en\/blog\/\">Blog<\/a> and on our social networks for updates on this topic.<\/p>\n<p>For more information and explanations about it, send us an 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: 16\/09\/2022 &#8211; Source: <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2022\/anvisa-atualiza-regras-para-regularizacao-de-dispositivos-medicos-no-brasil\">Anvisa<\/a><\/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=\"Anvisa updates rules for RDC n\u00ba 185\/2001 - regulation of medical devices in Brazil\r\nAnvisa released on its website on Wednesday (14\/09) a news informing about the update of the rules for regularization of medical devices in Brazil.\u00a0According to Anvisa, the Collegiate Board approved the proposal that revises RDC 185\/2001,\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-updates-rules-for-the-regularization-of-medical-devices-in-brazil\/\"><h4 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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":9454,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[67,68],"tags":[69,70,231,232,153,212],"class_list":["post-9444","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa-en","category-brazil","tag-anvisa-en","tag-brazil","tag-rdc185-en","tag-regularization-of-medical-devices","tag-regulatorio-en","tag-saude-en"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9444","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=9444"}],"version-history":[{"count":6,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9444\/revisions"}],"predecessor-version":[{"id":9465,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9444\/revisions\/9465"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/9454"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=9444"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=9444"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=9444"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}