{"id":18794,"date":"2025-10-24T09:19:37","date_gmt":"2025-10-24T12:19:37","guid":{"rendered":"https:\/\/sobelconsult.com\/automatic-issuance-impacts-anvisa-afe-consultation\/"},"modified":"2026-11-01T12:36:04","modified_gmt":"2026-11-01T15:36:04","slug":"emissao-automatica-impacta-na-anvisa-consulta-afe-e-mais","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/emissao-automatica-impacta-na-anvisa-consulta-afe-e-mais\/","title":{"rendered":"News: emiss\u00e3o autom\u00e1tica impacta na Anvisa consulta AFE e mais!"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">A realidade de muitos profissionais \u00e9 fazer uma Anvisa consulta AFE em suas rotinas regulat\u00f3rias. Mas a ag\u00eancia brasileira lan\u00e7ou uma novidade! <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Agora, os certificados de Autoriza\u00e7\u00e3o de Funcionamento (AFE) e Autoriza\u00e7\u00e3o Especial (AE) passam a ser emitidos automaticamente pelo sistema Solicita.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A medida reduz etapas manuais, diminui retrabalho e encurta prazos, modernizando um ponto cr\u00edtico do relacionamento entre empresas e a Ag\u00eancia.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para quem acompanha de perto o funcionamento da Anvisa consulta AFE, o movimento confirma a tend\u00eancia de digitaliza\u00e7\u00e3o e padroniza\u00e7\u00e3o de <a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/\">processos regulat\u00f3rios no Brasil<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-what-changes-in-practice-for-those-who-depend-on-afe-ae\">O que muda na pr\u00e1tica para quem depende da AFE\/AE?<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Antes da mudan\u00e7a, a emiss\u00e3o dos certificados exigia confer\u00eancia manual ap\u00f3s o deferimento do processo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Agora, <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/certificados-de-afe-e-ae-serao-emitidos-automaticamente-pelo-solicita\">com a automa\u00e7\u00e3o no Solicita,<\/a> o certificado \u00e9 gerado assim que o pedido \u00e9 aprovado, diretamente pelo sistema, sem necessidade de interven\u00e7\u00e3o adicional.<\/p>\n\n\n\n<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"569\" height=\"242\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/Exemplo-de-tela-de-validacao-no-Solicita-Anvisa.webp\" alt=\"Exemplo de tela de valida&#xE7;&#xE3;o no Solicita Anvisa\" class=\"wp-image-18779\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/Exemplo-de-tela-de-validacao-no-Solicita-Anvisa.webp 569w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/10\/Exemplo-de-tela-de-validacao-no-Solicita-Anvisa-300x128.webp 300w\" sizes=\"(max-width: 569px) 100vw, 569px\" \/><figcaption class=\"wp-element-caption\"><em>Exemplo da tela de valida\u00e7\u00e3o de documentos no Solicita. Fonte: Anvisa. <\/em><\/figcaption><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Para quem lida com Anvisa consulta AFE no dia a dia, isso se traduz em:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Tempo de resposta menor e maior previsibilidade;<\/li>\n\n\n\n<li>Processo padronizado e transparente;<\/li>\n\n\n\n<li>Acesso f\u00e1cil ao certificado na \u00e1rea do usu\u00e1rio;<\/li>\n\n\n\n<li>Menos erros e retrabalhos, j\u00e1 que o sistema \u00e9 integrado \u00e0s bases da Ag\u00eancia.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Essa atualiza\u00e7\u00e3o refor\u00e7a o compromisso da Anvisa em modernizar seus fluxos de trabalho e expandir o uso de solu\u00e7\u00f5es digitais. Algo que se alinha com outras iniciativas, como envios eletr\u00f4nicos e publica\u00e7\u00f5es automatizadas no Di\u00e1rio Oficial.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-why-companies-perform-an-anvisa-afe-consultation\">Por que as empresas fazem uma Anvisa consulta AFE<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A consulta AFE Anvisa \u00e9 uma das ferramentas mais acessadas por empresas reguladas, seja de dispositivos m\u00e9dicos ou IVDs.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ela serve para verificar a situa\u00e7\u00e3o da Autoriza\u00e7\u00e3o de Funcionamento, documento obrigat\u00f3rio para que fabricantes, importadores, distribuidores e armazenadores de produtos sujeitos \u00e0 vigil\u00e2ncia sanit\u00e1ria possam operar legalmente no Brasil.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Por meio dessa consulta, \u00e9 poss\u00edvel:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Confirmar se a empresa possui AFE v\u00e1lida ou deferida;<\/li>\n\n\n\n<li>Verificar se h\u00e1 processos em an\u00e1lise, suspensos ou cancelados;<\/li>\n\n\n\n<li>Comprovar regularidade junto a clientes e parceiros comerciais;<\/li>\n\n\n\n<li>Evitar riscos de san\u00e7\u00f5es administrativas, como advert\u00eancias ou interdi\u00e7\u00f5es.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">At\u00e9 recentemente, a obten\u00e7\u00e3o e atualiza\u00e7\u00e3o da AFE envolvia etapas manuais e espera por emiss\u00e3o formal do certificado ap\u00f3s o deferimento do processo.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Agora, com o Solicita, o certificado \u00e9 emitido automaticamente, o que elimina o intervalo entre o deferimento e a gera\u00e7\u00e3o do documento.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-why-automation-of-afe-ae-matters-for-the-regulated-sector\">Por que a automa\u00e7\u00e3o da AFE\/AE importa para o setor regulado<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Fabricantes, importadores e distribuidores de dispositivos m\u00e9dicos, cosm\u00e9ticos e IVDs dependem de previsibilidade para planejar lan\u00e7amentos e importa\u00e7\u00f5es.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Ao automatizar a emiss\u00e3o de certificados, a Anvisa reduz riscos operacionais e aumenta a confian\u00e7a nas informa\u00e7\u00f5es dispon\u00edveis publicamente.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para quem pesquisa \u201cAnvisa consulta AFE\u201d em busca de regulariza\u00e7\u00e3o ou atualiza\u00e7\u00e3o cadastral, essa mudan\u00e7a representa menos burocracia, mais transpar\u00eancia e maior efici\u00eancia.<\/p>\n\n\n\n<div class=\"wp-block-group sb-cta sb-cta-svc is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"sb-cta-eye wp-block-paragraph\">Servi\u00e7o relacionado<\/p>\n\n\n\n<p class=\"sb-cta-title wp-block-paragraph\">Registro de dispositivos m\u00e9dicos no Brasil, da AFE \u00e0 decis\u00e3o da ANVISA<\/p>\n\n\n\n<p class=\"sb-cta-out wp-block-paragraph\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/?utm_source=blog&#038;utm_medium=cta&#038;utm_campaign=automatic-issuance-impacts-anvisa-afe-consultation\">Conhe\u00e7a o servi\u00e7o \u2192<\/a><\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-international-overview-convergence-ai-and-clinical-trials\">Panorama internacional: converg\u00eancia, IA e ensaios cl\u00ednicos<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Enquanto a Anvisa implementa automa\u00e7\u00e3o na AFE\/AE, outras autoridades globais tamb\u00e9m avan\u00e7am:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-fda-public-consultation-on-ai-and-e20-guideline\">FDA: consulta p\u00fablica sobre IA e E20<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A ag\u00eancia norte americana abriu uma Request for Public Comment sobre <a href=\"https:\/\/www.fda.gov\/medical-devices\/digital-health-center-excellence\/request-public-comment-measuring-and-evaluating-artificial-intelligence-enabled-medical-device\">avalia\u00e7\u00e3o do desempenho de dispositivos m\u00e9dicos com IA<\/a>, buscando pr\u00e1ticas reais de monitoramento e gest\u00e3o de performance drift.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Al\u00e9m disso, a FDA divulgou a chamada <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/e20-adaptive-designs-clinical-trials\">E20: Adaptive Designs for Clinical Trials<\/a>. Trata-se de uma nova diretriz que orienta o uso de m\u00e9todos estat\u00edsticos flex\u00edveis em estudos cl\u00ednicos, reduzindo custos e acelerando inova\u00e7\u00f5es.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-nmpa-and-hsa-partnership\">Uni\u00e3o entre NMPA e HSA<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">A NMPA chinesa se reuniu com a autoridade de sa\u00fade de Singapura (HSA) <a href=\"https:\/\/english.nmpa.gov.cn\/2025-09\/16\/c_1125993.htm\">para discutir regimes regulat\u00f3rios de dispositivos m\u00e9dicos<\/a> e fortalecer confian\u00e7a m\u00fatua. Esse movimento faz parte de uma estrat\u00e9gia da China de harmoniza\u00e7\u00e3o com pa\u00edses vizinhos. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Esses avan\u00e7os mostram como diferentes autoridades (inclusive a Anvisa) est\u00e3o modernizando processos e integrando tecnologias para acompanhar a evolu\u00e7\u00e3o cient\u00edfica e digital.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-milestones-of-modernization\">Marcos de moderniza\u00e7\u00e3o<\/h2>\n\n\n\n<figure class=\"wp-block-image aligncenter size-large\"><img decoding=\"async\" width=\"1024\" height=\"682\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-1024x682.jpg\" alt=\"A imagem mostra um espa&#xE7;o de trabalho moderno, provavelmente em um laborat&#xF3;rio ou ambiente de engenharia. Em primeiro plano, h&#xE1; um estojo de pl&#xE1;stico r&#xED;gido azul com &#xF3;culos de seguran&#xE7;a apoiados em cima. Um cord&#xE3;o azul com um crach&#xE1; de identifica&#xE7;&#xE3;o est&#xE1; colocado pr&#xF3;ximo a ele. Em segundo plano, dois monitores de computador exibem modelos 3D ou desenhos t&#xE9;cnicos de bra&#xE7;os rob&#xF3;ticos. O espa&#xE7;o de trabalho tamb&#xE9;m inclui um teclado, um mouse e um copo com canetas coloridas, tudo sobre uma mesa branca e limpa. A cena transmite um ambiente profissional e organizado, focado em design, testes ou tecnologia de fabrica&#xE7;&#xE3;o.     \" class=\"wp-image-15524\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-1024x682.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-768x512.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec-1536x1024.jpg 1536w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/09\/hero-sec.jpg 2000w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">Como voc\u00ea viu, essa foi uma semana importante para o mercado regulat\u00f3rio mundial.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A automa\u00e7\u00e3o da Anvisa consulta AFE marca um passo importante rumo \u00e0 efici\u00eancia regulat\u00f3ria.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Empresas passam a contar com um sistema mais r\u00e1pido, confi\u00e1vel e integrado, capaz de reduzir a carga burocr\u00e1tica e fortalecer a seguran\u00e7a jur\u00eddica das opera\u00e7\u00f5es.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para o setor regulado, essa evolu\u00e7\u00e3o refor\u00e7a a import\u00e2ncia de acompanhar de perto cada atualiza\u00e7\u00e3o da Anvisa, garantindo que processos internos, cadastros e submiss\u00f5es estejam sempre alinhados \u00e0s novas pr\u00e1ticas.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">N\u00f3s sabemos que acompanhar todas essas mudan\u00e7as \u00e9 complexo! \u00c9 por isso que a Sobel monitora constantemente a Anvisa e outras autoridades para que nossos parceiros estejam sempre bem-informados!<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u00c9 isso que nos permite <a href=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/medical-device-registration-global\/\">conectar as tend\u00eancias internacionais<\/a> e pr\u00e1ticas locais para que as empresas estejam sempre um passo \u00e0 frente da regula\u00e7\u00e3o.<\/p>\n\n\n\n<div class=\"wp-block-group sb-cta sb-cta-band is-layout-flow wp-block-group-is-layout-flow\">\n<p class=\"sb-cta-eye wp-block-paragraph\">Como a Sobel pode ajudar<\/p>\n\n\n\n<p class=\"sb-cta-big wp-block-paragraph\">Precisa de apoio na sua <strong>jornada<\/strong> regulat\u00f3ria?<\/p>\n\n\n\n<p class=\"sb-cta-p wp-block-paragraph\">Cuidamos da AFE, da classifica\u00e7\u00e3o, do dossi\u00ea e do registro de dispositivos m\u00e9dicos no Brasil.<\/p>\n\n\n\n<p class=\"sb-cta-btns wp-block-paragraph\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/our-solutions-brazil\/?utm_source=blog&#038;utm_medium=cta&#038;utm_campaign=automatic-issuance-impacts-anvisa-afe-consultation#footer-cta\">Agende sua avalia\u00e7\u00e3o<\/a> <a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/produto-travado-na-anvisa\/\">Produto travado na ANVISA? \u2192<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>A Anvisa automatizou a emiss\u00e3o de certid\u00f5es por meio do sistema Solicita. Saiba o que muda na consulta Anvisa AFE! <\/p>\n","protected":false},"author":12,"featured_media":18790,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[489],"tags":[545],"market":[493],"content_type":[517],"class_list":["post-18794","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-todos-os-segmentos","tag-registro-e-acesso-ao-mercado-pt-br","market-brasil","content_type-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>News: emiss\u00e3o autom\u00e1tica impacta na Anvisa consulta AFE e mais! - Sobel<\/title>\n<meta name=\"description\" content=\"A Anvisa automatizou a emiss\u00e3o de certid\u00f5es por meio do sistema Solicita. 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