{"id":34286,"date":"2026-04-27T10:26:29","date_gmt":"2026-04-27T13:26:29","guid":{"rendered":"https:\/\/sobelconsult.com\/news-fda-and-ai-powered-medical-devices\/"},"modified":"2026-10-24T06:37:52","modified_gmt":"2026-10-24T09:37:52","slug":"dispositivos-medicos-com-inteligencia-artificial","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/dispositivos-medicos-com-inteligencia-artificial\/","title":{"rendered":"News: FDA e os dispositivos m\u00e9dicos com intelig\u00eancia artificial"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Voc\u00ea j\u00e1 ouviu falar em dispositivos m\u00e9dicos com intelig\u00eancia artificial?<\/strong> Com o avan\u00e7o da tecnologia, esse termo est\u00e1 se tornando cada vez mais comum. Por isso mesmo, est\u00e1 na mira das autoridades regulat\u00f3rias de todo o mundo. <\/p>\n\n<p class=\"wp-block-paragraph\">Nesse sentido, a FDA avan\u00e7a no marco regulat\u00f3rio para dispositivos m\u00e9dicos com intelig\u00eancia artificial. Mas para al\u00e9m do mercado norte americano, temos novidades relacionadas \u00e0s exig\u00eancias de sustentabilidade e vigil\u00e2ncia p\u00f3s-mercado. <\/p>\n\n<p class=\"wp-block-paragraph\">A seguir, <strong>reunimos os principais destaques regulat\u00f3rios recentes<\/strong> e explicamos por que eles merecem a aten\u00e7\u00e3o dos fabricantes.<\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 id=\"h-fda-advances-regulatory-framework-for-ai-powered-medical-devices\" class=\"wp-block-heading\"><strong>FDA avan\u00e7a no marco regulat\u00f3rio para dispositivos m\u00e9dicos com intelig\u00eancia artificial<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Os Estados Unidos representam <a href=\"https:\/\/sobelconsult.com\/pt-br\/registro-de-cosmeticos-estados-unidos\/\">um dos maiores mercados de dispositivos m\u00e9dicos<\/a> do mundo. Por isso, podemos esperar movimenta\u00e7\u00f5es que seguem as tend\u00eancias da evolu\u00e7\u00e3o da tecnologia. <\/p>\n\n<p class=\"wp-block-paragraph\">Nesse sentido, recentemente a Food and Drug Administration (FDA) tem trabalhado <strong>no seu <a href=\"https:\/\/www.mddionline.com\/artificial-intelligence\/fda-s-ai-device-regulations-key-updates-compliance-strategies-for-medtech-success\">marco regulat\u00f3rio para tecnologias baseadas em intelig\u00eancia artificial<\/a> e machine learning<\/strong> aplicadas \u00e0 \u00e1rea da sa\u00fade.<\/p>\n\n<p class=\"wp-block-paragraph\">As orienta\u00e7\u00f5es mais recentes abordam todo o ciclo de vida do produto, desde o desenvolvimento at\u00e9 o p\u00f3s\u2011mercado. O foco est\u00e1 em governan\u00e7a de dados, transpar\u00eancia, ciberseguran\u00e7a e uso de evid\u00eancias do mundo real.<\/p>\n\n<p class=\"wp-block-paragraph\">Um dos principais destaques \u00e9 o Predetermined Change Control Plan (PCCP), que permite que fabricantes planejem e obtenham aprova\u00e7\u00e3o pr\u00e9via para determinadas modifica\u00e7\u00f5es futuras em algoritmos, sem a necessidade de uma nova submiss\u00e3o a cada atualiza\u00e7\u00e3o.<\/p>\n\n<p class=\"wp-block-paragraph\">Esse modelo traz <strong>mais previsibilidade para empresas que desenvolvem dispositivos m\u00e9dicos com intelig\u00eancia artificial<\/strong>. Ao mesmo tempo, refor\u00e7a as responsabilidades relacionadas \u00e0 seguran\u00e7a e ao desempenho cont\u00ednuo da tecnologia.<\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 id=\"h-sustainability-becomes-a-key-factor-in-access-to-public-tenders-in-brazil-and-chile\" class=\"wp-block-heading\"><strong>Sustentabilidade passa a definir acesso a licita\u00e7\u00f5es p\u00fablicas no Brasil e no Chile<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">No Brasil e no Chile,<strong> <a href=\"https:\/\/www.meddeviceonline.com\/doc\/new-sustainability-mandates-in-brazil-and-chile-are-quietly-disqualifying-medical-devices-0001\">crit\u00e9rios ambientais passaram a ter peso decisivo em processos de compras p\u00fablicas<\/a> na \u00e1rea da sa\u00fade. <\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Ainda que um produto esteja devidamente registrado junto \u00e0 autoridade sanit\u00e1ria, ele<strong> pode ser eliminado na fase t\u00e9cnica da licita\u00e7\u00e3o caso n\u00e3o atenda a exig\u00eancias de sustentabilidade.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">No contexto brasileiro, a Lei n\u00ba 14.133\/2021 autoriza a avalia\u00e7\u00e3o do impacto ambiental ao longo do ciclo de vida do produto, incluindo requisitos como an\u00e1lise de ciclo de vida (LCA) e comprova\u00e7\u00e3o de log\u00edstica reversa.<\/p>\n\n<p class=\"wp-block-paragraph\">J\u00e1 no Chile, crit\u00e9rios ambientais v\u00eam sendo incorporados gradualmente \u00e0 pontua\u00e7\u00e3o t\u00e9cnica, refor\u00e7ando a necessidade de que fabricantes alinhem estrat\u00e9gia regulat\u00f3ria e estrat\u00e9gia comercial.<\/p>\n\n<p class=\"wp-block-paragraph\">Dica: <strong>o mercado Latino Americano tem se destacado como destino para fabricantes de dispositivos m\u00e9dicos. <\/strong>Na Sobel, temos especialistas regulat\u00f3rios focados nesses mercados. Que tal explorar as possibilidades de acessar pa\u00edses do Mercosul?<\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-3e41869c wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/sobelconsult.com\/pt-br\/#footer-cta\/\" style=\"background-color:#08225b\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Fale com Sobel<\/strong><\/a><\/div>\n<\/div>\n\n<div style=\"height:31px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 id=\"h-anvisa-establishes-cosmetovigilance-technical-committee\" class=\"wp-block-heading\"><strong>Anvisa institui C\u00e2mara T\u00e9cnica de Cosmetovigil\u00e2ncia<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\"><strong>A Anvisa anunciou a cria\u00e7\u00e3o de uma <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/anvisa-institui-camara-tecnica-de-cosmetovigilancia\">C\u00e2mara T\u00e9cnica de Cosmetovigil\u00e2ncia<\/a>. <\/strong>O objetivo \u00e9 fortalecer o monitoramento da seguran\u00e7a de produtos cosm\u00e9ticos ap\u00f3s a sua coloca\u00e7\u00e3o no mercado.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"667\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/03\/3d-rendering-of-personal-care-products-in-fondant-pink.jpg\" alt=\"Renderiza&#xE7;&#xE3;o em 3D de produtos de cuidados pessoais em rosa fondant\" class=\"wp-image-32979\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/03\/3d-rendering-of-personal-care-products-in-fondant-pink.jpg 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/03\/3d-rendering-of-personal-care-products-in-fondant-pink-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/03\/3d-rendering-of-personal-care-products-in-fondant-pink-768x512.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<p class=\"wp-block-paragraph\">A iniciativa busca <strong>ampliar a an\u00e1lise de dados, apoiar decis\u00f5es regulat\u00f3rias e promover maior integra\u00e7\u00e3o<\/strong> entre diferentes atores do setor.<\/p>\n\n<p class=\"wp-block-paragraph\">Esse movimento refor\u00e7a a import\u00e2ncia de estruturas robustas de vigil\u00e2ncia p\u00f3s\u2011comercializa\u00e7\u00e3o e sinaliza uma tend\u00eancia de maior maturidade regulat\u00f3ria no setor de cosm\u00e9ticos, alinhada a pr\u00e1ticas internacionais e \u00e0 RDC n\u00ba 894\/2024.<\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 id=\"h-china-discusses-new-mandatory-safety-standard-for-cosmetics\" class=\"wp-block-heading\"><strong>China discute novo padr\u00e3o obrigat\u00f3rio de seguran\u00e7a para cosm\u00e9ticos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Falando em cosm\u00e9ticos, a autoridade sanit\u00e1ria chinesa<strong> abriu consulta p\u00fablica para o primeiro <a href=\"https:\/\/cisema.com\/news\/china-toothpaste-safety-standard\">padr\u00e3o nacional obrigat\u00f3rio de seguran\u00e7a aplic\u00e1vel a cremes dentais<\/a>. <\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">A proposta estabelece requisitos t\u00e9cnicos mais claros e refor\u00e7a o controle regulat\u00f3rio sobre produtos cosm\u00e9ticos comercializados no pa\u00eds.<\/p>\n\n<p class=\"wp-block-paragraph\">Para fabricantes com atua\u00e7\u00e3o internacional, o avan\u00e7o de padr\u00f5es obrigat\u00f3rios na China refor\u00e7a a necessidade de <strong>acompanhar de perto mudan\u00e7as regulat\u00f3rias locais e adaptar rapidamente dossi\u00eas t\u00e9cnicos e estrat\u00e9gias de compliance <\/strong>a cada mercado de destino.<\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 id=\"h-artificial-intelligence-safety-and-sustainability\" class=\"wp-block-heading\"><strong>Intelig\u00eancia artificial, seguran\u00e7a e sustentabilidade<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">Toda semana, uma s\u00e9rie de mudan\u00e7as acontecem nos mercados regulados ao redor do mundo.<\/p>\n\n<p class=\"wp-block-paragraph\">Dos dispositivos m\u00e9dicos com intelig\u00eancia artificial, passando pelos requisitos sustent\u00e1veis, at\u00e9 a seguran\u00e7a cosm\u00e9tica: s\u00e3o movimentos que podem afetar os fabricantes;<\/p>\n\n<p class=\"wp-block-paragraph\">Em conjunto, essas atualiza\u00e7\u00f5es mostram que o acesso a mercado deixou de depender apenas do registro regulat\u00f3rio formal.<\/p>\n\n<p class=\"wp-block-paragraph\">Al\u00e9m disso, tamb\u00e9m mostram que \u00e9 preciso estar um passo a frente e se manter bem informado! <strong>Para isso, a Newsletter regulat\u00f3ria da Sobel faz toda a diferen\u00e7a.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Quinzenalmente, enviamos de forma gratuita um e-mail com as not\u00edcias regulat\u00f3rias mais importantes do Brasil, Estados Unidos, Europa, \u00c1sia e outros mercados. <strong>Cadastre-se clicando no bot\u00e3o abaixo!<\/strong><\/p>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-3e41869c wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/sobelconsult.com\/pt-br\/?popup=810\" style=\"background-color:#08225b\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Receba a News!<\/strong><\/a><\/div>\n<\/div>\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p class=\"wp-block-paragraph\">Lembre-se: a informa\u00e7\u00e3o \u00e9 essencial para reduzir riscos, evitar retrabalho e garantir competitividade em um ambiente regulat\u00f3rio cada vez mais complexo.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Saiba mais sobre o marco regulat\u00f3rio da FDA sobre os dispositivos m\u00e9dicos com intelig\u00eancia artificial e mais atualiza\u00e7\u00f5es.<\/p>\n","protected":false},"author":12,"featured_media":34281,"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":[537],"market":[501],"content_type":[517],"class_list":["post-34286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivo-medico","tag-software-e-ia-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 e os dispositivos m\u00e9dicos com intelig\u00eancia artificial - Sobel<\/title>\n<meta name=\"description\" content=\"Saiba mais sobre o marco regulat\u00f3rio da FDA sobre os dispositivos m\u00e9dicos com intelig\u00eancia artificial e mais 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