{"id":9421,"date":"2022-09-02T13:53:35","date_gmt":"2022-09-02T16:53:35","guid":{"rendered":"https:\/\/passarini.com.br\/passrod-has-joined-abimed\/"},"modified":"2022-09-02T14:57:30","modified_gmt":"2022-09-02T17:57:30","slug":"anvisa-now-requires-digital-signatures-in-medical-device-processes-and-petitions","status":"publish","type":"post","link":"https:\/\/passarini.com.br\/en\/anvisa-now-requires-digital-signatures-in-medical-device-processes-and-petitions\/","title":{"rendered":"Anvisa now requires digital signatures in medical device processes and petitions"},"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\">Anvisa now requires digital signatures in medical device processes and petitions<\/h2>\n<p>The National Health Surveillance Agency \u2013 ANVISA circulated this week through Solicita System the Circular Letter No. 1\/2022\/SEI\/GGTPS\/DIRE3\/ANVISA, which mainly provides with guidelines for <strong>signatures in process and petition documents for medical devices.<\/strong><\/p>\n<p>In this letter, Anvisa informs that the processes, petitions and documents filed must be digitally signed by the legally authorized person (or persons) of the company. To this end, e-CNPJ or e-CPF type certificates must be used, issued by certifying authorities recognized by the Brazilian Public Key Infrastructure \u2013 ICP\/Brasil, as provided in the Collegiate Board Resolutio \u2013 <a href=\"https:\/\/passarini.com.br\/wp-content\/uploads\/2022\/09\/RDC_470_2021_PT_Passarini_Group.pdf\">RDC n\u00b0 470\/2021.<\/a><\/p>\n<p>Scanned documents must exclusively use a qualified signature (with a digital certificate in the ICP-Brasil standard), as provided for in Decree No. <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/decreto-n-10.278-de-18-de-marco-de-2020-248810105\">10.278\/2020<\/a>. Native-digital documents, on the other hand. Can make use of both qualified (ICP-Brasil) and advanced signatures (used on the Gov.BR portal, at no cost to the citizen), according to Law No. <a href=\"https:\/\/www.in.gov.br\/en\/web\/dou\/-\/lei-n-14.063-de-23-de-setembro-de-2020-279185931\">14.063\/2020.<\/a><\/p>\n<p>Therefore, as provided for in art. 10 of RDC 470\/2021, signature formats that are not provided for in the legislation for processes, petitions and documents filed will no longer be accepted.<\/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: 02\/09\/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 now requires digital signatures in medical device processes and petitions\r\nThe National Health Surveillance Agency \u2013 ANVISA circulated this week through Solicita System the Circular Letter No. 1\/2022\/SEI\/GGTPS\/DIRE3\/ANVISA, which mainly provides with guidelines for signatures in process and petition documents for medical devices.\r\n\r\nIn this letter, Anvisa informs that the processes,\" data-link=\"https:\/\/passarini.com.br\/en\/passrod-has-joined-abimed-2\/\"><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%2Fpassrod-has-joined-abimed-2%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 href=\"https:\/\/x.com\/intent\/post?text=Passarini%20Group&amp;url=https%3A%2F%2Fpassarini.com.br%2Fen%2Fpassrod-has-joined-abimed-2%2F\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"X\" aria-label=\"X\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"X\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-twitter awb-icon-twitter\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"https:\/\/www.linkedin.com\/shareArticle?mini=true&amp;url=https%3A%2F%2Fpassarini.com.br%2Fen%2Fpassrod-has-joined-abimed-2%2F&amp;title=Passarini%20Group&amp;summary=Anvisa%20now%20requires%20digital%20signatures%20in%20medical%20device%20processes%20and%20petitions%0D%0AThe%20National%20Health%20Surveillance%20Agency%20%E2%80%93%20ANVISA%20circulated%20this%20week%20through%20Solicita%20System%20the%20Circular%20Letter%20No.%201%2F2022%2FSEI%2FGGTPS%2FDIRE3%2FANVISA%2C%20which%20mainly%20provides%20with%20guidelines%20for%20signatures%20in%20process%20and%20petition%20documents%20for%20medical%20devices.%0D%0A%0D%0AIn%20this%20letter%2C%20Anvisa%20informs%20that%20the%20processes%2C\" target=\"_blank\" rel=\"noopener noreferrer\" title=\"LinkedIn\" aria-label=\"LinkedIn\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"LinkedIn\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-linkedin awb-icon-linkedin\" style=\"color:#ffffff;background-color:#0077b5;border-color:#0077b5;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><span><a href=\"mailto:?subject=Passarini%20Group&amp;body=https%3A%2F%2Fpassarini.com.br%2Fen%2Fpassrod-has-joined-abimed-2%2F\" target=\"_self\" title=\"Email\" aria-label=\"Email\" data-placement=\"top\" data-toggle=\"tooltip\" data-title=\"Email\"><i class=\"fusion-social-network-icon fusion-tooltip fusion-mail awb-icon-mail\" style=\"color:#ffffff;background-color:#000000;border-color:#000000;border-radius:4px;\" aria-hidden=\"true\"><\/i><\/a><\/span><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_4 1_4 fusion-one-fourth fusion-column-last\" style=\"--awb-bg-size:cover;width:25%;width:calc(25% - ( ( 4% ) * 0.25 ) );\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-2\"><h3 data-fontsize=\"22\" data-lineheight=\"48\"><strong>More news:<\/strong><\/h3>\n<\/div><div class=\"fusion-recent-posts fusion-recent-posts-1 avada-container layout-default layout-columns-1\"><section class=\"fusion-columns columns fusion-columns-1 columns-1\"><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-12T17:31:31-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/siud-anvisa-udi-medical-devices-brazil-2026-deadlines\/\">SIUD Anvisa: The Complete Guide to the New UDI Database and 2026 Deadlines<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-02T16:07:37-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/fda-qmsr-medical-device-regulation-update\/\">FDA Unleashes New QMSR: A Game Changer for Medical Device Quality Management<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-26T16:10:51-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/simplified-process-trap-anvisa-denials-class-i-ii\/\">The Simplified Process Trap: Why Do Classes I and II Generate More Rejections at ANVISA?<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-06T10:58:24-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/anvisa-new-scheduling-system-compliance-rules\/\">New ANVISA System: 3 Essential Compliance Rules and the 5-Year Risk<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-10-28T17:48:37-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/anvisa-automates-afe-ae-end-of-waiting\/\">ANVISA Revolution: AFE and AE Are Now Automatic!<\/a><\/h4><\/div><\/article><article class=\"post fusion-column column col col-lg-12 col-md-12 col-sm-12\"><div class=\"recent-posts-content\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/passarini.com.br\/en\/author\/anderson\/\" title=\"Posts by Anderson Vieira\" rel=\"author\">Anderson Vieira<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2025-11-26T16:11:15-03:00<\/span><h4 class=\"entry-title\"><a href=\"https:\/\/passarini.com.br\/en\/devices-medical-new-export-route\/\">Devices to America: How U.S. Tariffs Are Changing Medical Device Exports<\/a><\/h4><\/div><\/article><\/section><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":16,"featured_media":9433,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[68],"tags":[69,70,228,152,153,203],"class_list":["post-9421","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-brazil","tag-anvisa-en","tag-brazil","tag-national-health-surveillance-agency","tag-produtos-para-a-saude-en","tag-regulatorio-en","tag-solicita-system"],"_links":{"self":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9421","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=9421"}],"version-history":[{"count":5,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9421\/revisions"}],"predecessor-version":[{"id":9432,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/posts\/9421\/revisions\/9432"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media\/9433"}],"wp:attachment":[{"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/media?parent=9421"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/categories?post=9421"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/passarini.com.br\/en\/wp-json\/wp\/v2\/tags?post=9421"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}