{"id":8267,"date":"2022-05-31T10:59:22","date_gmt":"2022-05-31T13:59:22","guid":{"rendered":"https:\/\/passarini.com.br\/anvisa-solicita-system-2\/"},"modified":"2022-07-26T08:55:01","modified_gmt":"2022-07-26T11:55:01","slug":"anvisa-rdc-no-687-gmp","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-rdc-no-687-gmp\/","title":{"rendered":"ANVISA &#8211; RDC No. 687 GMP"},"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; <\/strong><\/span><span style=\"color: black;\">RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices<\/span><\/h2>\n<p>Published on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.<\/p>\n<p>The new legislation will get into force on June 1st, 2022. The new RDC 687\/2022 revoques RDC 183\/2017.<\/p>\n<ul>\n<li>Certification continues to be mandatory for manufacturers of class III and IV medical devices that produces final products on their behalf or for another company;<\/li>\n<li>The scope of the new RDC applies now for the activity of sterile barrier\u2019s packing system for products declared as sterile. This is now considered a requirement for Certification of Good Manufacturing Practices (Brazil). It will also be required for IVD manufacturing sites that perform the steps of impregnation, lamination or cutting of immunochromatography strips;<\/li>\n<li>The structure of the standard were changed (chapters, articles and order);<\/li>\n<li>New definitions have been added and the list of documents for the petition has been changed as well;<\/li>\n<li>A period of 180 days was established for companies that need to make the necessary adequation and protocols.<\/li>\n<\/ul>\n<p>NOTE: The deadline for renewal remains as established in RDC 497\/2021<\/p>\n<p>Link to access RDC 687\/2022 in english, <span style=\"color: #0000ff;\"><strong><a style=\"color: #0000ff;\" href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/07\/RDC_687_2022_EN_Passarini_Group.pdf\" data-wpmeteor-mouseover=\"true\" data-wpmeteor-mouseout=\"true\">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: 05\/31\/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 - RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices\r\nPublished on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.\r\n\r\nThe new legislation will get\" data-link=\"https:\/\/passarini.com.br\/en\/anvisa-rdc-no-687-gmp\/\"><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-no-687-gmp%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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