{"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":"2026-04-30T08:25:09","modified_gmt":"2026-04-30T11:25:09","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

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

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

A seguir, reunimos os principais destaques regulat\u00f3rios recentes<\/strong> e explicamos por que eles merecem a aten\u00e7\u00e3o dos fabricantes.<\/p>\n\n

FDA avan\u00e7a no marco regulat\u00f3rio para dispositivos m\u00e9dicos com intelig\u00eancia artificial<\/strong><\/h2>\n\n

Os Estados Unidos representam 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

Nesse sentido, recentemente a Food and Drug Administration (FDA) tem trabalhado no seu marco regulat\u00f3rio para tecnologias baseadas em intelig\u00eancia artificial<\/a> e machine learning<\/strong> aplicadas \u00e0 \u00e1rea da sa\u00fade.<\/p>\n\n

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

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

Esse modelo traz 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

Sustentabilidade passa a definir acesso a licita\u00e7\u00f5es p\u00fablicas no Brasil e no Chile<\/strong><\/h2>\n\n

No Brasil e no Chile, crit\u00e9rios ambientais passaram a ter peso decisivo em processos de compras p\u00fablicas<\/a> na \u00e1rea da sa\u00fade. <\/strong><\/p>\n\n

Ainda que um produto esteja devidamente registrado junto \u00e0 autoridade sanit\u00e1ria, ele pode ser eliminado na fase t\u00e9cnica da licita\u00e7\u00e3o caso n\u00e3o atenda a exig\u00eancias de sustentabilidade.<\/strong><\/p>\n\n

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

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

Dica: 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

\n
Fale com Sobel<\/strong><\/a><\/div>\n<\/div>\n\n

Anvisa institui C\u00e2mara T\u00e9cnica de Cosmetovigil\u00e2ncia<\/strong><\/h2>\n\n

A Anvisa anunciou a cria\u00e7\u00e3o de uma 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

\"Renderização<\/figure>\n\n

A iniciativa busca 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

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

China discute novo padr\u00e3o obrigat\u00f3rio de seguran\u00e7a para cosm\u00e9ticos<\/strong><\/h2>\n\n

Falando em cosm\u00e9ticos, a autoridade sanit\u00e1ria chinesa abriu consulta p\u00fablica para o primeiro padr\u00e3o nacional obrigat\u00f3rio de seguran\u00e7a aplic\u00e1vel a cremes dentais<\/a>. <\/strong><\/p>\n\n

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

Para fabricantes com atua\u00e7\u00e3o internacional, o avan\u00e7o de padr\u00f5es obrigat\u00f3rios na China refor\u00e7a a necessidade de 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

Intelig\u00eancia artificial, seguran\u00e7a e sustentabilidade<\/strong><\/h2>\n\n

Toda semana, uma s\u00e9rie de mudan\u00e7as acontecem nos mercados regulados ao redor do mundo.<\/p>\n\n

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

Em conjunto, essas atualiza\u00e7\u00f5es mostram que o acesso a mercado deixou de depender apenas do registro regulat\u00f3rio formal.<\/p>\n\n

Al\u00e9m disso, tamb\u00e9m mostram que \u00e9 preciso estar um passo a frente e se manter bem informado! Para isso, a Newsletter regulat\u00f3ria da Sobel faz toda a diferen\u00e7a.<\/strong><\/p>\n\n

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. Cadastre-se clicando no bot\u00e3o abaixo!<\/strong><\/p>\n\n

\n
Receba a News!<\/strong><\/a><\/div>\n<\/div>\n\n

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":"

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":16,"featured_media":34281,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[308],"tags":[264,329,127,142,156,309],"class_list":["post-34286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-pt-br","tag-anvisa-pt-br","tag-china-pt-br","tag-cosmeticos-pt-br","tag-dispositivos-medicos","tag-fda-pt-br","tag-noticias-pt-br"],"yoast_head":"\nNews: 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 atualiza\u00e7\u00f5es.\" \/>\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\/dispositivos-medicos-com-inteligencia-artificial\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"News: FDA e os dispositivos m\u00e9dicos com intelig\u00eancia artificial\" \/>\n<meta property=\"og:description\" content=\"Saiba mais sobre o marco regulat\u00f3rio da FDA sobre os dispositivos m\u00e9dicos com intelig\u00eancia artificial e mais atualiza\u00e7\u00f5es.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/dispositivos-medicos-com-inteligencia-artificial\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-27T13:26:29+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-04-30T11:25:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/04\/Lab-technician-doctor-analyzing-virus-evolution-looking-on-digital-tablet.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"563\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Bruna Marzarotto\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Bruna Marzarotto\" \/>\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\\\/dispositivos-medicos-com-inteligencia-artificial\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/dispositivos-medicos-com-inteligencia-artificial\\\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/person\\\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"News: FDA e os dispositivos m\u00e9dicos com intelig\u00eancia artificial\",\"datePublished\":\"2026-04-27T13:26:29+00:00\",\"dateModified\":\"2026-04-30T11:25:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/dispositivos-medicos-com-inteligencia-artificial\\\/\"},\"wordCount\":854,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/dispositivos-medicos-com-inteligencia-artificial\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2026\\\/04\\\/Lab-technician-doctor-analyzing-virus-evolution-looking-on-digital-tablet.jpg\",\"keywords\":[\"Anvisa\",\"China\",\"Cosm\u00e9ticos\",\"Dispositivos m\u00e9dicos\",\"FDA\",\"Not\u00edcias\"],\"articleSection\":[\"Not\u00edcias\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/dispositivos-medicos-com-inteligencia-artificial\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/dispositivos-medicos-com-inteligencia-artificial\\\/\",\"name\":\"News: FDA e os dispositivos m\u00e9dicos com intelig\u00eancia artificial - 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