{"id":7758,"date":"2022-04-14T10:26:59","date_gmt":"2022-04-14T13:26:59","guid":{"rendered":"https:\/\/passarini.com.br\/anvisa-rdc-657-regularization-of-software-as-a-medical-device-2\/"},"modified":"2022-04-20T13:13:36","modified_gmt":"2022-04-20T16:13:36","slug":"anvisa-rdc-no665-gmp-for-medical-products-and-in-vitro-diagnostic-products","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-rdc-no665-gmp-for-medical-products-and-in-vitro-diagnostic-products\/","title":{"rendered":"ANVISA &#8211; RDC N\u00ba 665, GMP for Medical Products and In Vitro Diagnostic Products"},"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; Published on March 30th: RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.<\/strong><\/span><\/h2>\n<h3 style=\"margin: 0cm; background: white;\"><span style=\"font-family: 'Segoe UI',sans-serif; color: #242424;\">The new RDC will come into force on May 2nd, 2022. The new RDC 665\/2022 revoked RDC 16\/2013 and incorporated IN 8 of 2013.<\/span><\/h3>\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. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products. See more details below:<\/p>\n<ol>\n<li>The scope of the new RDC is now expanded and mentions manufacturers, distributors, storers and importers of medical devices and in vitro diagnostic products that are commercialized in Brazil;<\/li>\n<li>There were changes in the structure of the standard (chapters, articles) as well as minor text adjustments;<\/li>\n<li>The management representative remains mandatory, being more explicit;<\/li>\n<li>It is now an explicit requirement to establish the responsibility, authority and interrelationship of all personnel who manage, perform and verify quality-related work;<\/li>\n<li>RDC 665 details the Risk Management requirements, however there is no difference to what is already expected to be implemented;<\/li>\n<li>Continuous Risk Management Process, RDC 665 clarifies that the points of continuous analysis of the GER, which is already established by ISO14971:2019<\/li>\n<li>The design requirements remain, they were just reorganized;<\/li>\n<li>Evidence that suppliers have received specifications for materials and services is now required for each purchase.<\/li>\n<li>Article 70 mentions that all personnel who are in contact with the product or its environment must be clean, healthy and properly dressed. This also includes people outside the organization as service providers.<\/li>\n<li>Inspection of labels and instructions for use must be documented in the product&#8217;s historical record. This requirement is now applicable to importers.<\/li>\n<li>It was made clear that all documents must be available whenever requested by health surveillance agencies.<\/li>\n<\/ol>\n<ul>\n<li>Stay Tuned: authorization letters that mentioned RDC 16\/2013 must be changed to the new RDC665\/2022<\/li>\n<li style=\"font-style: inherit; font-weight: inherit;\">References, including chapters and structures, to RDC 16\/2013 in quality documents must be changed as well.<\/li>\n<\/ul>\n<p>Link to access RDC 665\/2022 in english, <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/04\/RDC_665_2022_EN_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\/14\/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 - Published on March 30th: RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.\r\nThe new RDC will come into force on May 2nd, 2022. The new RDC 665\/2022 revoked RDC 16\/2013 and\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-rdc-no665-gmp-for-medical-products-and-in-vitro-diagnostic-products\/\"><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%2Fanvisa-rdc-no665-gmp-for-medical-products-and-in-vitro-diagnostic-products%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 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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