{"id":1351,"date":"2025-06-23T10:22:49","date_gmt":"2025-06-23T13:22:49","guid":{"rendered":"https:\/\/sisvida.com.br\/?p=1351"},"modified":"2025-06-23T10:55:40","modified_gmt":"2025-06-23T13:55:40","slug":"entenda-o-que-ha-de-novo-na-rdc-978-2025","status":"publish","type":"post","link":"https:\/\/sisvida.com.br\/index.php\/entenda-o-que-ha-de-novo-na-rdc-978-2025\/","title":{"rendered":"Entenda o que h\u00e1 de novo na RDC 978\/2025"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">A nova <\/span><b>Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) n\u00ba 978\/2025<\/b><span style=\"font-weight: 400;\">, publicada pela ANVISA no \u00faltimo dia 10 de junho, j\u00e1 est\u00e1 movimentando os laborat\u00f3rios de an\u00e1lises cl\u00ednicas em todo o Brasil. O texto, que revoga oficialmente a RDC n\u00ba 786\/2023, reformula diretrizes e refor\u00e7a crit\u00e9rios t\u00e9cnico-sanit\u00e1rios que laborat\u00f3rios p\u00fablicos e privados devem seguir para manter suas atividades regulares e em conformidade com as normas da vigil\u00e2ncia sanit\u00e1ria.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Com vig\u00eancia imediata e prazo de 90 dias para adapta\u00e7\u00e3o \u2014 at\u00e9 8 de setembro de 2025 \u2014, a RDC 978 imp\u00f5e uma s\u00e9rie de ajustes operacionais, estruturais e documentais. Entretanto, clientes do <\/span><b>VIDA<\/b><span style=\"font-weight: 400;\"> t\u00eam um al\u00edvio: o sistema j\u00e1 incorpora as exig\u00eancias previstas na norma, eliminando a necessidade de solu\u00e7\u00f5es paralelas ou adapta\u00e7\u00f5es de \u00faltima hora.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Nova classifica\u00e7\u00e3o dos servi\u00e7os<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Entre as principais mudan\u00e7as, est\u00e1 a adi\u00e7\u00e3o dos servi\u00e7os itinerantes, que regulamentam\u00a0 coletas independentes\/fora de um laborat\u00f3rio, espec\u00edficas como domic\u00edlio, empresas e estabelecimentos, por\u00e9m, que n\u00e3o podem ser feitos de forma cont\u00ednua e regular para que n\u00e3o se caracterize como um servi\u00e7o fixo. O artigo designa explicitamente postos de coleta que n\u00e3o sejam em laborat\u00f3rios como um grupo espec\u00edfico. Cada grupo, al\u00e9m dos j\u00e1 mencionados anteriormente na RDC 786\/2023 de Tipo I, II e III passam a ter obriga\u00e7\u00f5es distintas com base em seu porte, infraestrutura e escopo de atua\u00e7\u00e3o.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">No VIDA, essa categoriza\u00e7\u00e3o j\u00e1 pode ser definida por unidade, com impacto direto nos relat\u00f3rios, permiss\u00f5es e rotinas automatizadas.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Cadastro do paciente: mais completo e humanizado<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A resolu\u00e7\u00e3o refor\u00e7a a necessidade de um cadastro mais detalhado do paciente, incluindo dados como nome da m\u00e3e, sexo biol\u00f3gico, nome do respons\u00e1vel legal para menores e a op\u00e7\u00e3o de nome social \u2013 este \u00faltimo, especialmente importante para popula\u00e7\u00f5es trans e n\u00e3o bin\u00e1rias.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O sistema VIDA j\u00e1 oferece esses campos com valida\u00e7\u00f5es autom\u00e1ticas e controle de obrigatoriedade, garantindo precis\u00e3o e rastreabilidade.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Laudos com identidade e validade jur\u00eddica<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A RDC 978 mant\u00e9m a obrigatoriedade da assinatura legalmente v\u00e1lida nos laudos \u2013 seja f\u00edsica ou digital qualificada. Al\u00e9m disso, refor\u00e7a a necessidade de exibi\u00e7\u00e3o do CNES do laborat\u00f3rio, identifica\u00e7\u00e3o do respons\u00e1vel t\u00e9cnico e dados do laborat\u00f3rio de apoio, quando aplic\u00e1vel.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O VIDA oferece laudos certificados digitalmente, com valida\u00e7\u00e3o por ICP-Brasil tipo A1, atendendo integralmente \u00e0 Lei n\u00ba 14.063\/2020.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Qualidade, rastreabilidade e seguran\u00e7a operacional<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Outro ponto central da RDC \u00e9 a exig\u00eancia de programas de garantia da qualidade (PGQ). Isso inclui o uso de indicadores de desempenho, auditorias internas, controle da rastreabilidade de amostras e valida\u00e7\u00f5es de m\u00e9todos e equipamentos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O VIDA responde com uma robusta trilha de auditoria, hist\u00f3rico completo de amostras e painel de indicadores integrados, al\u00e9m de m\u00f3dulos espec\u00edficos para manuten\u00e7\u00e3o de equipamentos e controle de ensaios de profici\u00eancia.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Prote\u00e7\u00e3o de dados e LGPD<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A nova resolu\u00e7\u00e3o tamb\u00e9m refor\u00e7a diretrizes da Lei Geral de Prote\u00e7\u00e3o de Dados (LGPD), exigindo restri\u00e7\u00e3o de acessos, controle de visualiza\u00e7\u00e3o de dados sens\u00edveis e registro de a\u00e7\u00f5es sobre os dados.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Com hierarquias de usu\u00e1rios e trilhas de acesso, o VIDA j\u00e1 est\u00e1 plenamente adequado a esse aspecto, oferecendo ainda oculta\u00e7\u00e3o seletiva de resultados e relat\u00f3rios com identifica\u00e7\u00e3o de quem acessou cada informa\u00e7\u00e3o.<\/span><\/p>\n<ul>\n<li aria-level=\"1\">\n<h2><b>Impactos na gest\u00e3o de contratos e res\u00edduos<\/b><\/h2>\n<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">A ANVISA passa a exigir maior rigor tamb\u00e9m nos contratos com terceiros, incluindo cl\u00e1usulas de responsabilidade t\u00e9cnica e controle de qualidade. Al\u00e9m disso, h\u00e1 exig\u00eancias espec\u00edficas para gest\u00e3o de res\u00edduos, higieniza\u00e7\u00e3o e controle ambiental.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O sistema VIDA permite a inclus\u00e3o de documentos e contratos digitalizados, checklists de limpeza e registros de descarte de res\u00edduos, todos audit\u00e1veis.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Para os mais de 600 laborat\u00f3rios que j\u00e1 utilizam o sistema VIDA, a adequa\u00e7\u00e3o \u00e0 RDC 978\/2025 \u00e9 mais simples, pois o VIDA est\u00e1 estruturado n\u00e3o s\u00f3 para cumprir, mas para facilitar a conformidade com qualquer nova resolu\u00e7\u00e3o da ANVISA.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Laborat\u00f3rios que ainda n\u00e3o se adaptaram \u00e0 nova resolu\u00e7\u00e3o devem agir com urg\u00eancia. A RDC 978\/2025 entra em vigor em setembro, e o descumprimento poder\u00e1 acarretar penalidades sanit\u00e1rias e at\u00e9 a suspens\u00e3o do funcionamento.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Quer saber como o VIDA pode ajudar seu laborat\u00f3rio a estar 100% em conformidade? Fale com a nossa equipe e agende uma apresenta\u00e7\u00e3o<\/span><\/p>\n<p>Confira a RDC 978\/2025 completa: https:\/\/drive.google.com\/file\/d\/1uueUepQ3rdbrCpouj2XnowHbzG8GDp1k\/view<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A nova Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) n\u00ba 978\/2025, publicada pela ANVISA no \u00faltimo dia 10 de junho, j\u00e1 est\u00e1 movimentando os laborat\u00f3rios de an\u00e1lises cl\u00ednicas em todo o Brasil. O texto, que revoga oficialmente a RDC n\u00ba 786\/2023, reformula diretrizes e refor\u00e7a crit\u00e9rios t\u00e9cnico-sanit\u00e1rios que laborat\u00f3rios p\u00fablicos e privados devem seguir para manter suas [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":1355,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[5,7],"tags":[],"class_list":["post-1351","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-analises-clinicas","category-gestao-laboratorial"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v18.7 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Entenda o que h\u00e1 de novo na RDC 978\/2025 - VIDA - Software para Laborat\u00f3rio<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sisvida.com.br\/index.php\/entenda-o-que-ha-de-novo-na-rdc-978-2025\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Entenda o que h\u00e1 de novo na RDC 978\/2025\" \/>\n<meta property=\"og:description\" content=\"A nova Resolu\u00e7\u00e3o da Diretoria Colegiada (RDC) n\u00ba 978\/2025, publicada pela ANVISA no \u00faltimo dia 10 de junho, j\u00e1 est\u00e1 movimentando os laborat\u00f3rios de an\u00e1lises cl\u00ednicas em todo o Brasil. O texto, que revoga oficialmente a RDC n\u00ba 786\/2023, reformula diretrizes e refor\u00e7a crit\u00e9rios t\u00e9cnico-sanit\u00e1rios que laborat\u00f3rios p\u00fablicos e privados devem seguir para manter suas [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sisvida.com.br\/index.php\/entenda-o-que-ha-de-novo-na-rdc-978-2025\/\" \/>\n<meta property=\"og:site_name\" content=\"VIDA - Software para Laborat\u00f3rio\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-23T13:22:49+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-23T13:55:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sisvida.com.br\/wp-content\/uploads\/2025\/06\/Blog-Capa-8-1-scaled.png\" \/>\n\t<meta property=\"og:image:width\" content=\"2560\" \/>\n\t<meta property=\"og:image:height\" content=\"1280\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Emilly Ferreira\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Emilly Ferreira\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/\"},\"author\":{\"name\":\"Emilly Ferreira\",\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/#\\\/schema\\\/person\\\/7b9db9eae67f53bc7d53c9fd3e526df6\"},\"headline\":\"Entenda o que h\u00e1 de novo na RDC 978\\\/2025\",\"datePublished\":\"2025-06-23T13:22:49+00:00\",\"dateModified\":\"2025-06-23T13:55:40+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/\"},\"wordCount\":791,\"publisher\":{\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sisvida.com.br\\\/wp-content\\\/uploads\\\/2025\\\/06\\\/Blog-Capa-8-1-scaled.png\",\"articleSection\":[\"An\u00e1lises Cl\u00ednicas\",\"Gest\u00e3o Laboratorial\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/\",\"url\":\"https:\\\/\\\/sisvida.com.br\\\/index.php\\\/entenda-o-que-ha-de-novo-na-rdc-978-2025\\\/\",\"name\":\"Entenda o que h\u00e1 de novo na RDC 978\\\/2025 - 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