{"id":5203,"date":"2020-10-26T11:09:37","date_gmt":"2020-10-26T14:09:37","guid":{"rendered":"https:\/\/passarini.com.br\/rdc-no-270_2019-notification-of-risk-class-i-medical-devices-2\/"},"modified":"2021-11-16T11:26:27","modified_gmt":"2021-11-16T14:26:27","slug":"resolution-of-the-directive-board-rdc-431-anvisa","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/resolution-of-the-directive-board-rdc-431-anvisa\/","title":{"rendered":"Resolution of the Directive Board (RDC) 431, ANVISA"},"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=\"NEWLESTTER\" width=\"1920\" height=\"500\" class=\"wp-image-7069\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-200x52.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-300x78.webp 300w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-400x104.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-600x156.webp 600w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-768x200.webp 768w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-800x208.webp 800w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1024x267.webp 1024w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1200x313.webp 1200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1-1536x400.webp 1536w, https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/10\/1920x500_informativos_noticias-1.webp 1920w\" sizes=\"(max-width: 800px) 100vw, 1200px\" \/><\/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\"><p><strong>Resolution of the Directive Board (RDC) 431, October 31st, 2020 &#8211; ANVISA<\/strong><\/p>\n<p><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registrationrecord\">ANVISA<\/a> has published the Resolution of the Directive Board <span style=\"color: #000000;\"><strong>RDC 431\/2020<\/strong><\/span> where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is responsible for imputing and updating the instructions for use. This procedure applies to medical devices of all risk classifications.<\/p>\n<p>The <span style=\"color: #000000;\"><strong>RDC 431\/2020<\/strong><\/span> becomes in force from <strong><span style=\"color: #000000;\">November 1st, 2020<\/span><\/strong>. The instructions for use of products regularized until this day must be uploaded to ANVISA\u2019s website within <span style=\"color: #000000;\"><strong>12 months<\/strong><\/span>. The instructions for use for products approved after November 1st\u00a0 must be uploaded within <span style=\"color: #000000;\"><strong>30 days<\/strong><\/span> after the favorable conclusion of the petition or after implementation of the non-reportable change that implies a change in the instructions for use.<\/p>\n<p>The instructions for use uploaded on ANVISA\u2019s website will be available for consultation in the ANVISA\u2019s database. The content of the instructions for use must be under the legislation in force and must be consistent with the regularized product.<\/p>\n<p>In cases of regularized medical devices without a User Manual or similar material, the company must load the label model in the ANVISA\u2019s website, in the instruction for use field.<\/p>\n<p>The lack of uploading of the instruction for use may generate an extra evaluation of documents and taxes by ANVISA at any time. ANVISA also may withdraw the instructions for use of the website, restore an earlier version of the document, or determine other penalties provided for in <span style=\"color: #000000;\"><strong>Law 6.437\/1977<\/strong><\/span>.<\/p>\n<p>Access the full content of the Resolution in the link below:<\/p>\n<p><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" title=\"RESOLU\u00c7\u00c3O DA DIRETORIA COLEGIADA - RDC N\u00ba 270, DE 28 DE FEVEREIRO DE 2019\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2020\/11\/RDC-N-431-13-october-2020-EN.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">RDC N\u00ba 431<\/a><\/strong><\/span><\/p>\n<p>For more information and explanations about it, send us an e-mail:\u00a0<strong><span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"mailto:contato@passarini.com.br\">contato@passarini.com.br<\/a><\/span><\/strong><\/p>\n<p><span style=\"color: #000000;\"><strong>Passarini Regulatory Affairs<\/strong><\/span><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>You may also be interested in:<\/p>\n<p><a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">ANVISA Registration<\/a><br \/>\n<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anatel-approval\/\">ANATEL Approval<\/a><br \/>\n<a href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/inmetro-certification\/\">INMETRO Certification<\/a><\/p>\n<p>Published: 10\/26\/2020<\/p>\n<\/div><div class=\"fusion-sharing-box fusion-sharing-box-1 boxed-icons has-taglines layout-floated layout-medium-floated layout-small-floated\" style=\"background-color:#f6f6f6;--awb-layout:row;--awb-alignment-small:space-between;\" data-title=\"Passarini Regulatory Affairs\" data-description=\"Resolution of the Directive Board (RDC) 431, October 31st, 2020 - ANVISA\r\n\r\nANVISA has published the Resolution of the Directive Board RDC 431\/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is responsible for imputing\" data-link=\"https:\/\/passarini.com.br\/en\/resolution-of-the-directive-board-rdc-431-anvisa\/\"><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%2Fresolution-of-the-directive-board-rdc-431-anvisa%2F&amp;t=Passarini%20Regulatory%20Affairs\" 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 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