{"id":11452,"date":"2024-01-16T09:22:59","date_gmt":"2024-01-16T12:22:59","guid":{"rendered":"https:\/\/passarini.com.br\/launch-new-brand-passarini-europe-solutions\/"},"modified":"2024-07-04T14:51:48","modified_gmt":"2024-07-04T17:51:48","slug":"rdc-830-2023-new-regulations-for-medical-devices-2","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/rdc-830-2023-new-regulations-for-medical-devices-2\/","title":{"rendered":"RDC 830\/2023 New Regulations 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\"><h2 class=\"headingpostinterno\">RDC 830\/2023 comes into force from june 1, 2024<\/h2>\n<p>RDC 830\/2023, provides for the risk classification notification and registration regimes, and labeling requirements and instructions for in vitro diagnosis, including their instruments, comes into force from the <strong>1st of june 2024.<\/strong><\/p>\n<p>With the publication of the RDC 830\/2023, several changes to the regulation of in vitro diagnostic medical devices were made , including:<\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-image-element fusion-image-align-center in-legacy-container\" style=\"text-align:center;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><div class=\"imageframe-align-center\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><a class=\"fusion-no-lightbox\" href=\"https:\/\/bit.ly\/47ztLNT\" target=\"_blank\" aria-label=\"capa_folha_rdc_830_passarini_group\" rel=\"noopener noreferrer\"><img decoding=\"async\" width=\"210\" height=\"300\" alt=\"RDC 830\/2023 comes into force from june 1, 2024\" src=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/01\/capa_folha_rdc_830_passarini_group-210x300.webp\" class=\"img-responsive wp-image-11459\" srcset=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/01\/capa_folha_rdc_830_passarini_group-200x286.webp 200w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/01\/capa_folha_rdc_830_passarini_group-210x300.webp 210w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/01\/capa_folha_rdc_830_passarini_group-400x571.webp 400w, https:\/\/passarini.com.br\/wp-content\/uploads\/2024\/01\/capa_folha_rdc_830_passarini_group.webp 500w\" sizes=\"(max-width: 800px) 100vw, 210px\" \/><\/a><\/span><\/div><\/div><div class=\"fusion-text fusion-text-2\"><ul>\n<li>The RDC 830\/2023 removed the products below froom the list of non-applicable products, that is, these products must be considered in the new RDC:\n<p>IV &#8211; laboratory reagentes intended for diagnosis in any type of non-human sample.<\/p>\n<p>XI &#8211; software for in vitro diagnostics not embedded in the equipment, which is dealt with in specific regulations.<\/li>\n<li>&nbsp;\n<p>RDC 830\/2023 does not apply to products intended exclusively for use in technical assistance or maintenance procedures.<\/li>\n<li>&nbsp;\n<p>Change of some definitions and inclusion of definitions that are in accordance with the current context, facilitating the understanding of the legislation.<\/li>\n<li>&nbsp;\n<p>Inclusion of specific classification rules, such as:<\/p>\n<p>f) to be used as diagnostic tests for therapeutic selection or to provide essential information for the safe and effective use of a medicine or biological product (used as companion diagnostic medical devices);<\/li>\n<li>&nbsp;\n<p>Alteration of some classification rules.<\/li>\n<li>&nbsp;\n<p>Added to RDC 830\/2023 a section to deal with the types of Change notification and Registration of Medical Device for in vitro Diagnostics \u2013 Change of immediate implementation, change of approval required and non-reportable alteration.<\/li>\n<li>&nbsp;\n<p>Permission to deplete the stock of packaging, labels and instructions for use for a period of 120 days from the publication of the alteration.<\/li>\n<li>&nbsp;\n<p>Labels and instructions for use:<\/p>\n<p>New text:<\/p>\n<p>\u201cthe inclusion of information from national companies on labels in addition to the legal manufacturer and\/or holder of the registration or notification is prohibited;\u201d<\/p>\n<p>\u201cWhen the dimensions of the product packaging allow, information about instructions for use may appear on its label.\u201d<\/li>\n<li>&nbsp;\n<p>Inclusion of a list of devices for which instructions for use in non-printed format are not permitted.<\/li>\n<li>&nbsp;\n<p>The dossier format has been changed. It is similar to the dossier presented in RDC 751\/2022.<\/li>\n<li>&nbsp;\n<p>Establishes a period of 365 days, counting from June 1, 2024, for notification holders to file petitions for sanitary reclassification of products that had their notification regime modified for registration according to the classification rules.<\/li>\n<li>&nbsp;\n<p>Control devices without assigned quantitative or qualitative values that are now classified as medical devices for in vitro diagnosis and products for the extraction of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA), auxiliary to in vitro diagnostic procedures, must be duly regularized within 365 days from June 1, 2024.<\/li>\n<\/ul>\n<p>Is your company ready for the changes? Update yourself, access the Portuguese version of <strong><a href=\"https:\/\/bit.ly\/47ztLNT\">RDC 830\/2023.<\/a><\/strong><\/p>\n<\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"margin-left: auto;margin-right: auto;width:100%;\"><\/div><div class=\"fusion-sep-clear\"><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:10px;\"><p>With the entry into force of RDC 830\/2023, the following legislation will be revoked:<\/p>\n<p>I &#8211; the Resolution of the Collegiate Board of Directors &#8211; RDC n\u00ba 36, of August 26, 2015;<br \/>\nII &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 211, of January 22, 2018;<br \/>\nIII &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 270, of February 28, 2019;<br \/>\nIV &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 340, of March 6, 2020;<br \/>\nV &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 403, of July 21, 2020;<br \/>\nVI &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 431, of October 13, 2020;<br \/>\nVII &#8211; the Collegiate Board Resolution &#8211; RDC n\u00ba 27, of May 2, 2008;<br \/>\nVIII &#8211; Normative Instruction &#8211; IN n\u00ba 30, of March 19, 2019;<br \/>\nIX &#8211; Normative Instruction &#8211; IN n\u00ba 4, of June 15, 2012;<br \/>\nX &#8211; art. 11 of the Normative Instruction &#8211; IN n\u00ba 3, of August 26, 2015.<\/p>\n<p>For further information, please contact Passarini Group! We will be pleased to assist you via email: <strong><a href=\"mailto:contato@passarini.com.br?subject=Passarini%20Europe%20Solutions\">clique aqui!<\/a><\/strong><\/p>\n<h2><span style=\"color: #000000;\"><strong>Fly higher with Passarini Group!<\/strong><\/span><\/h2>\n<p>Published on: 01\/16\/2024<\/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=\" RDC 830\/2023 entra em vigor a partir de 1\u00ba de junho de 2024.\" data-description=\"RDC 830\/2023 comes into force from june 1, 2024\r\nRDC 830\/2023, provides for the risk classification notification and registration regimes, and labeling requirements and instructions for in vitro diagnosis, including their instruments, comes into force from the 1st of june 2024.\r\n\r\nWith the publication of the RDC 830\/2023, several changes to the\" data-link=\"https:\/\/passarini.com.br\/en\/?p=11452\"><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%2F%3Fp%3D11452&amp;t=%20RDC%20830%2F2023%20entra%20em%20vigor%20a%20partir%20de%201%C2%BA%20de%20junho%20de%202024.\" 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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class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":11489,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[72,248,216],"tags":[267,295],"class_list":["post-11452","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ce-mark","category-europa-en","category-regulatorios-en","tag-medical-devices","tag-regulation"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11452","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=11452"}],"version-history":[{"count":8,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11452\/revisions"}],"predecessor-version":[{"id":11500,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/11452\/revisions\/11500"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/11489"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=11452"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=11452"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=11452"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}