{"id":24299,"date":"2025-12-19T08:01:46","date_gmt":"2025-12-19T11:01:46","guid":{"rendered":"https:\/\/sobelconsult.com\/fda-publishes-q3e-for-extractables-leachables\/"},"modified":"2026-10-31T20:23:01","modified_gmt":"2026-10-31T23:23:01","slug":"fda-publishes-q3e-for-extractables-leachables","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/fda-publishes-q3e-for-extractables-leachables\/","title":{"rendered":"News: FDA publica Q3E para extra\u00edveis e lixivi\u00e1veis"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">O FDA publicou um <strong>novo guideline alinhado \u00e0 ICH Q3E para orientar a avalia\u00e7\u00e3o de extra\u00edveis e lixivi\u00e1veis (Extractables &amp; Leachables \u2013 E&amp;L), <\/strong>acompanhado de documenta\u00e7\u00e3o de suporte com monografias para a chamada Class 3 leachables.<\/p>\n\n<p class=\"wp-block-paragraph\">O material refor\u00e7a uma abordagem baseada em risco. Ou seja, <strong>eleva as expectativas<\/strong> sobre:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>a robustez dos estudos anal\u00edticos,<\/li>\n\n\n\n<li>a defini\u00e7\u00e3o de limites de exposi\u00e7\u00e3o,<\/li>\n\n\n\n<li>e a justificativa da correla\u00e7\u00e3o entre materiais, processo produtivo e uso pretendido do produto.<\/li>\n<\/ul>\n\n<p class=\"wp-block-paragraph\">Na pr\u00e1tica, isso sinaliza uma cobran\u00e7a maior por rastreabilidade de dados, consist\u00eancia cient\u00edfica e racional toxicol\u00f3gico ao longo do dossi\u00ea. <strong>Especialmente em submiss\u00f5es ao FDA.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Para os fabricantes que dependem de <a href=\"https:\/\/sobelconsult.com\/pt-br\/iso-10993-de-biocompatibilidade-atualizacao\/\" target=\"_blank\" rel=\"noreferrer noopener\">avalia\u00e7\u00f5es de biocompatibilidade<\/a>, risco qu\u00edmico e seguran\u00e7a de materiais, esse movimento <strong>tende a impactar o planejamento de estudos, cronogramas e estrat\u00e9gia de documenta\u00e7\u00e3o.<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Empresas que revisarem desde j\u00e1 suas estrat\u00e9gias de avalia\u00e7\u00e3o (alinhando estudos, relat\u00f3rios e racional regulat\u00f3rio \u00e0s expectativas do Q3E) podem reduzir o risco de questionamentos, exig\u00eancias adicionais e atrasos no processo regulat\u00f3rio. Al\u00e9m disso, conseguem <strong>fortalecer a qualidade t\u00e9cnica de suas submiss\u00f5es.<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Clique para conferir o <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/q3e-guideline-extractables-and-leachables\">guideline Q3E para Extra\u00edveis e Lixivi\u00e1veis.<\/a><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-health-canada-proposes-regulatory-changes-for-medical-devices\"><strong>Health Canada prop\u00f5e mudan\u00e7as regulat\u00f3rias para dispositivos m\u00e9dicos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Al\u00e9m do novo guia do FDA sobre extra\u00edveis e lixivi\u00e1veis, <strong>o Health Canada tamb\u00e9m prop\u00f4s a moderniza\u00e7\u00e3o dos requisitos regulat\u00f3rios para dispositivos m\u00e9dicos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Nesse sentido, a ag\u00eancia canadense colocou em <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/medical-devices-compliance-bulletin\/consultation-modernizing-mdel-framework-phase-ii.html\">discuss\u00e3o iniciativas para atualizar o marco regulat\u00f3rio<\/a> de dispositivos m\u00e9dicos no pa\u00eds. Poss\u00edveis ajustes podem impactar processos de conformidade e vigil\u00e2ncia p\u00f3s-mercado. <\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Esse tipo de mudan\u00e7a regulat\u00f3ria merece acompanhamento pr\u00f3ximo.<\/strong> Afinal, pode influenciar prazos, evid\u00eancias e planejamento de licen\u00e7as ao longo do ciclo de vida do produto.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-anvisa-updates-medical-device-regularization-manual\"><strong>Anvisa atualiza manual de regulariza\u00e7\u00e3o de equipamentos m\u00e9dicos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\"><strong>No Brasil, a Anvisa disponibilizou uma nova vers\u00e3o do <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2025\/anvisa-publica-nova-versao-de-manual-para-regularizacao-de-equipamentos-medicos\">Manual de Regulariza\u00e7\u00e3o de Produtos m\u00e9dicos<\/a>.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Esse manual re\u00fane orienta\u00e7\u00f5es atualizadas sobre classifica\u00e7\u00e3o, requisitos documentais e procedimentos para regulariza\u00e7\u00e3o no pa\u00eds.<\/p>\n\n<p class=\"wp-block-paragraph\">Assim, espera-se que o material ajude a reduzir interpreta\u00e7\u00f5es divergentes e apoiar fabricantes na tomada de decis\u00e3o sobre enquadramento, documenta\u00e7\u00e3o e estrat\u00e9gias de submiss\u00e3o.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"612\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg\" alt=\"Registro de dispositivo m&#xE9;dico da Anvisa no laptop.\" class=\"wp-image-19147\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-1024x612.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-300x179.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration-768x459.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/Anvisa-Medical-Device-Registration.jpg 1500w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\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\">Dispositivos m\u00e9dicos<\/p>\n\n\n\n<p class=\"sb-cta-title wp-block-paragraph\">J\u00e1 tem registro na Anvisa? Seu dossi\u00ea \u00e9 a base para Europa, Reino Unido, EUA e Canad\u00e1<\/p>\n\n\n\n<p class=\"sb-cta-out wp-block-paragraph\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/home\/nossas-solucoes-2\/dispositivos-medicos\/?utm_source=blog&#038;utm_medium=cta&#038;utm_campaign=fda-publishes-q3e-for-extractables-leachables\">Ver a consultoria para dispositivos m\u00e9dicos \u2192<\/a><\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-china-publishes-new-guidelines-to-accelerate-cosmetic-market-entry\"><strong>China publica novas diretrizes para acelerar a entrada de cosm\u00e9ticos no mercado<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Saindo do mercado brasileiro com o manual e do norte americano com o guia de extra\u00edveis e lixivi\u00e1veis, <strong>a China publicou <a href=\"https:\/\/english.www.gov.cn\/news\/202511\/17\/content_WS691b1a63c6d00ca5f9a079e3.html\">novas diretrizes com o objetivo de estimular a inova\u00e7\u00e3o e acelerar o acesso ao mercado de produtos cosm\u00e9ticos<\/a>.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">As medidas buscam ampliar previsibilidade regulat\u00f3ria, ajustar processos de avalia\u00e7\u00e3o e incentivar produtos inovadores.<\/p>\n\n<p class=\"wp-block-paragraph\">Dessa forma, marcas que avaliam expans\u00e3o internacional (ou que j\u00e1 atuam na regi\u00e3o), tem mais um sinal de que o <strong>ambiente regulat\u00f3rio est\u00e1 se movimentando para equilibrar agilidade e controle.<\/strong><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-sobel-tip-iso-10993-1-guide-for-medical-devices\"><strong>Dica Sobel: Guia ISO 10993-1 para dispositivos m\u00e9dicos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Anteriormente, falamos sobre a avalia\u00e7\u00e3o de extra\u00edveis e lixivi\u00e1veis. Mas voc\u00ea sabia que isso faz parte de uma estrat\u00e9gia mais ampla de biocompatibilidade, <strong>estruturada a partir da ISO 10993-1?<\/strong> <\/p>\n\n<p class=\"wp-block-paragraph\">Essa norma \u00e9 a base para a avalia\u00e7\u00e3o de risco biol\u00f3gico e qu\u00edmico de dispositivos m\u00e9dicos e orienta como definir, justificar e documentar a estrat\u00e9gia de testes ao longo do ciclo de vida do produto.<\/p>\n\n<p class=\"wp-block-paragraph\">Recentemente, <strong>a norma passou por atualiza\u00e7\u00f5es importantes.<\/strong> Para facilitar o entendimento do \u201cantes e depois\u201d, preparamos um <a href=\"https:\/\/sobelconsult.com\/pt-br\/materiais\/atualizacao-2025-da-iso-10993-1\/\">Guia ISO 10993-1:2025.<\/a><\/p>\n\n<p class=\"wp-block-paragraph\">Desenvolvido pelo time de Seguran\u00e7a Humana da Sobel, o guia traz como era a ISO 10993-1 anteriormente, como ficou e quais as a\u00e7\u00f5es esperadas por parte do fabricante. E o melhor: com download gratuito! <strong>E o melhor de tudo: ele est\u00e1 dispon\u00edvel para download gratuito!<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\"><strong>Fa\u00e7a o download agora:<\/strong> basta clicar aqui: https:\/\/sobelconsult.com\/materiais\/atualizacao-2025-da-iso-10993-1<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-why-do-these-updates-matter\">Por que essas atualiza\u00e7\u00f5es importam?<\/h2>\n\n<p class=\"wp-block-paragraph\">Essas not\u00edcias refor\u00e7am uma tend\u00eancia global: maior rigor t\u00e9cnico, busca por previsibilidade e atualiza\u00e7\u00e3o cont\u00ednua de requisitos. Seja em temas altamente t\u00e9cnicos (como extra\u00edveis e lixivi\u00e1veis), seja em ajustes estruturais de marcos regulat\u00f3rios e guias operacionais.<\/p>\n\n<p class=\"wp-block-paragraph\">Para empresas que atuam em mercados regulados, acompanhar esse cen\u00e1rio de perto \u00e9 parte do planejamento de conformidade.<\/p>\n\n<p class=\"wp-block-paragraph\">Lembre-se: se voc\u00ea quiser receber essas atualiza\u00e7\u00f5es com rapidez, assine gratuitamente a <a href=\"https:\/\/sobelconsult.com\/pt-br\/?popup=810\">Sobel News Round Up<\/a> e receba no seu e-mail tudo o que pode impactar o seu neg\u00f3cio.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>O FDA publicou um novo guideline alinhado \u00e0 ICH Q3E para orientar a avalia\u00e7\u00e3o de extra\u00edveis e lixivi\u00e1veis (Extractables &amp; Leachables \u2013 E&amp;L), acompanhado de documenta\u00e7\u00e3o de suporte com monografias para a chamada Class 3 leachables. O material refor\u00e7a uma abordagem baseada em risco. Ou seja, eleva as expectativas sobre: Na pr\u00e1tica, isso sinaliza uma [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":24012,"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":[138],"tags":[208,549],"market":[501],"content_type":[517],"class_list":["post-24299","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivo-medico","tag-avaliacao-biologica","tag-toxicologia-pt-br","market-eua","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: FDA publica Q3E para extra\u00edveis e lixivi\u00e1veis - Sobel<\/title>\n<meta name=\"description\" content=\"Veja o que muda com o guia Q3E do FDA sobre extra\u00edveis e lixivi\u00e1veis, al\u00e9m de atualiza\u00e7\u00f5es no Canad\u00e1, Brasil e China.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/sobelconsult.com\/pt-br\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News: FDA publica Q3E para extra\u00edveis e lixivi\u00e1veis\" \/>\n<meta property=\"og:description\" content=\"Veja o que muda com o guia Q3E do FDA sobre extra\u00edveis e lixivi\u00e1veis, al\u00e9m de atualiza\u00e7\u00f5es no Canad\u00e1, Brasil e China.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/fda-publishes-q3e-for-extractables-leachables\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2025-12-19T11:01:46+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-10-31T23:23:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/12\/medical-device-ivd.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Maik Endler\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Maik Endler\" \/>\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:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/\"},\"author\":{\"name\":\"Maik Endler\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/person\\\/7cb020654e2f235d6175a2734c2b5e28\"},\"headline\":\"News: FDA publica Q3E para extra\u00edveis e lixivi\u00e1veis\",\"datePublished\":\"2025-12-19T11:01:46+00:00\",\"dateModified\":\"2026-10-31T23:23:01+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/\"},\"wordCount\":809,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/12\\\/medical-device-ivd.jpg\",\"keywords\":[\"Avalia\u00e7\u00e3o biol\u00f3gica\",\"Toxicologia\"],\"articleSection\":[\"Dispositivos m\u00e9dicos\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-publishes-q3e-for-extractables-leachables\\\/\",\"name\":\"News: FDA publica Q3E para extra\u00edveis e lixivi\u00e1veis - 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