{"id":9475,"date":"2022-09-22T13:52:20","date_gmt":"2022-09-22T16:52:20","guid":{"rendered":"https:\/\/passarini.com.br\/?p=9475"},"modified":"2023-02-24T09:00:18","modified_gmt":"2023-02-24T12:00:18","slug":"rdc-751-2022-risk-classification-the-notification-and-registration-regimes","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/rdc-751-2022-risk-classification-the-notification-and-registration-regimes\/","title":{"rendered":"RDC 751\/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use 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\"><h1 class=\"documentFirstHeading\">RDC 751\/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices.<\/h1>\n<p>Resolution &#8211; RDC no. 751, of september 15, 2022 was published yesterday (21\/09) in the official Gazette of the Union, which provides for risk classification, notification and registration regimes, and labeling and instructions for use of medical devices.<\/p>\n<p>In addition to the changes previously informed by Anvisa and also released by Passarini <a href=\"https:\/\/passarini.com.br\/en\/anvisa-updates-rules-for-the-regularization-of-medical-devices-in-brazil\/\">last week<\/a>, the new RDC includes new, more up-to-date definitions, thus facilitating the understanding of the requirements established in RDC 751\/2022.<\/p>\n<p>RDC 751\/2022 enters into force on <strong>March 1, 2023<\/strong>, the date on which the following laws will also be repealed:<\/p>\n<ul>\n<li>I &#8211; the Resolution of the Collegiate Board of Directors &#8211; RDC No. 185, of October 22, 2001;<\/li>\n<li>II &#8211; Resolution &#8211; RE No. 1554, of August 19, 2002;<\/li>\n<li>III &#8211; the Resolution of the Collegiate Board of Directors &#8211; RDC No. 207, of November 7, 2006;<\/li>\n<li>IV &#8211; items I and II of article 2, and item II of article 5 of the Normative Instruction &#8211; IN n\u00ba 4, of June 15, 2012;<\/li>\n<li>V &#8211; the Resolution of the Collegiate Board of Directors &#8211; RDC No. 15, of March 28, 2014;<\/li>\n<li>VI &#8211; the Resolution of the Collegiate Board of Directors &#8211; RDC No. 40, of August 26, 2015.<\/li>\n<\/ul>\n<p>Is your company prepared for the changes? Update yourself, access the Portuguese version of <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/bit.ly\/3CiwTjP\">RDC 751\/2022<\/a>.<\/strong><\/span><\/p>\n<p>Count on us in this update. Our team of experts is available for any clarifications.<\/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: 22\/08\/2022 &#8211; Source: <a href=\"http:\/\/antigo.anvisa.gov.br\/legislacao#\/visualizar\/493728\">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=\"RDC 751\/2022: Risk classification, the notification and registration regimes, and the requirements for labeling and instructions for use for medical devices.\r\nResolution - RDC no. 751, of september 15, 2022 was published yesterday (21\/09) in the official Gazette of the Union, which provides for risk classification, notification and registration regimes, and\" data-link=\"https:\/\/passarini.com.br\/en\/rdc-751-2022-risk-classification-the-notification-and-registration-regimes\/\"><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%2Frdc-751-2022-risk-classification-the-notification-and-registration-regimes%2F&amp;t=Passarini%20Group\" 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 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