{"id":7683,"date":"2022-04-05T09:41:22","date_gmt":"2022-04-05T12:41:22","guid":{"rendered":"https:\/\/passarini.com.br\/udi-for-brazil-anvisa-2\/"},"modified":"2022-04-05T09:54:17","modified_gmt":"2022-04-05T12:54:17","slug":"anvisa-rdc-657-regularization-of-software-as-a-medical-device","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-rdc-657-regularization-of-software-as-a-medical-device\/","title":{"rendered":"ANVISA &#8211; RDC N\u00ba 657, Regularization of software as a medical device"},"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\"><h2><span style=\"color: #000000;\"><strong>ANVISA &#8211;\u00a0COLLEGIATE BOARD RESOLUTION &#8211; RDC N\u00ba 657, OF MARCH 24, 2022: Provides for the regularization of software as a medical device (Software as a Medical Device \u2013 SaMD)<\/strong><\/span><\/h2>\n<p><span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/en\/portfolio-items\/anvisa-registration\/\">ANVISA<\/a><\/strong><\/span> published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION &#8211; RDC No. 657, OF MARCH 24, 2022, which provides for the regularization of software as a medical device (Software as a Medical Device \u2013 SaMD), a milestone for the software market in Brazil, as it is ANVISA&#8217;s first RDC that deals exclusively with this product category.<\/p>\n<p>Effective from July 1, 2022, <span style=\"color: #0000ff;\"><strong>RDC 657\/2022<\/strong><\/span> establishes the requirements for the regularization of software as a medical device (Software as a Medical Device &#8211; SaMD), defined as Software that meets the definition of a medical device, may be in vitro diagnostics (IVD) or not, being intended for one or more medical indications, and which accomplish those purposes without being part of medical device hardware. Includes mobile applications and software for in vitro purposes, if their indications are included in the general definition of medical devices. This definition includes, among others, software licensed by subscription and centrally hosted (Software as a Service), which meets the definition of medical devices.<\/p>\n<p>According to <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/04\/RDC_657_2022_Blog_Passarini_Group.pdf\">RDC 657\/2022<\/a><\/strong><\/span>, software with medical applications that are considered accessories for the exclusive use of medical devices and software with embedded medical applications must be regularized together with the medical devices under the associated health surveillance regime. In addition, SaMD must be framed in the rules and classes according to the Collegiate Board Resolution &#8211; RDC No. 185, of October 22, 2001, or subsequent regulations.<\/p>\n<p>For SaMD for in vitro, notwithstanding the risk classification of SaMD for in vitro, its regularization must follow the other rules in accordance with the Resolution of the Collegiate Board of Directors &#8211; RDC No. 185, of October 22, 2001, or subsequent regulations.<\/p>\n<p>The SaMD developed internally (in house) by the health service and for the exclusive use of the health service, head office or branches, which fall into risk classes I and II, will not be subject to regularization at Anvisa, as long as they do not interfere with the functioning of medical devices subject to regularization, being prohibited their commercialization or donation of the SaMD developed internally, without proper regularization at Anvisa.<\/p>\n<p>Finally, the regularization of a SaMD must follow the general provisions of medical devices, in particular the Collegiate Board Resolution &#8211; RDC n\u00ba 185, of October 22, 2001, and the Collegiate Board Resolution &#8211; RDC n\u00ba 40, of August 2015, including its updates, and the manufacturer is not allowed to commercialize, in the form of licensing or equivalent, or to make the SaMD or its updates available to new users with expired or canceled regularization.<\/p>\n<p>Link to access RDC 657\/2022 in portuguese, <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/04\/RDC_657_2022_Blog_Passarini_Group.pdf\">click here<\/a><\/strong><\/span>.<\/p>\n<p>For more <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/en\/services\/\">information<\/a><\/strong><\/span> 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<h4><span style=\"color: #000000;\"><strong>Passarini Group<\/strong><\/span><\/h4>\n<p>Published: 04\/05\/2022<\/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 -\u00a0COLLEGIATE BOARD RESOLUTION - RDC N\u00ba 657, OF MARCH 24, 2022: Provides for the regularization of software as a medical device (Software as a Medical Device \u2013 SaMD)\r\nANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION - RDC\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-rdc-no-657-regularization-of-software-as-a-medical-device\/\"><h4 class=\"tagline\" 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