{"id":20665,"date":"2025-11-21T08:43:00","date_gmt":"2025-11-21T11:43:00","guid":{"rendered":"https:\/\/sobelconsult.com\/fda-iso-13485-harmonization\/"},"modified":"2025-11-21T09:57:52","modified_gmt":"2025-11-21T12:57:52","slug":"fda-iso-13485-harmonization","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/fda-iso-13485-harmonization\/","title":{"rendered":"Not\u00edcias: Harmoniza\u00e7\u00e3o da ISO 13485 da FDA e outras atualiza\u00e7\u00f5es regulat\u00f3rias"},"content":{"rendered":"\n

A FDA publicou uma nova vers\u00e3o preliminar de orienta\u00e7\u00e3o detalhando a transi\u00e7\u00e3o para o Regulamento do Sistema de Gerenciamento de Qualidade (QMSR). <\/strong>Essa \u00e9 considerada uma das revis\u00f5es mais significativas da estrutura regulat\u00f3ria de qualidade da Ag\u00eancia nas \u00faltimas d\u00e9cadas.<\/p>\n\n

O objetivo \u00e9 alinhar<\/strong> ainda mais os requisitos da FDA com os princ\u00edpios da<\/strong> ISO 13485:2016<\/strong>, consolidando a harmoniza\u00e7\u00e3o entre as duas normas.<\/p>\n\n

O documento prop\u00f5e ajustes de terminologia e responsabilidades revisadas. Ele tamb\u00e9m esclarece o que ser\u00e1 exigido em auditorias, inspe\u00e7\u00f5es e envios t\u00e9cnicos. <\/p>\n\n

Esse esfor\u00e7o de harmoniza\u00e7\u00e3o da ISO 13485 da FDA exige que os fabricantes revisem seus sistemas de gerenciamento de qualidade. Essa revis\u00e3o \u00e9 essencial para a conformidade! Ela afeta especialmente processos como controle de projeto, CAPA e rastreabilidade. <\/p>\n\n

As futuras submiss\u00f5es \u00e0 FDA podem exigir evid\u00eancias mais robustas de conformidade, afetando os cronogramas e o escopo das auditorias.<\/p>\n\n

Essa transi\u00e7\u00e3o marca uma etapa importante na harmoniza\u00e7\u00e3o da ISO 13485 da FDA e deve orientar as estrat\u00e9gias regulat\u00f3rias nos pr\u00f3ximos anos.<\/p>\n\n

Para as empresas que operam no mercado americano, esse movimento representa tanto um alerta quanto uma oportunidade estrat\u00e9gica. Aqueles que se preparam com anteced\u00eancia reduzem os riscos e fortalecem sua posi\u00e7\u00e3o competitiva.<\/strong><\/p>\n\n

Dica:<\/strong> se voc\u00ea deseja preparar a sua equipe para a ISO 13485, saiba mais sobre o treinamento exclusivo da Sobel (on-line ou presencial). Envie-nos uma mensagem para receber mais informa\u00e7\u00f5es sobre nosso treinamento em ISO 13485<\/a>!<\/strong><\/p>\n\n

Anvisa anuncia plano para reduzir o atraso de dispositivos m\u00e9dicos<\/strong><\/h2>\n\n

A Anvisa anunciou um webinar para apresentar seu novo plano para reduzir as filas de an\u00e1lise relacionadas a dispositivos m\u00e9dicos.<\/strong><\/p>\n\n

A iniciativa visa tornar os cronogramas mais previs\u00edveis e aumentar a efici\u00eancia das avalia\u00e7\u00f5es t\u00e9cnicas. Esse \u00e9 um ponto cr\u00edtico para os fabricantes que aguardam registros, renova\u00e7\u00f5es ou altera\u00e7\u00f5es p\u00f3s-aprova\u00e7\u00e3o. <\/p>\n\n

O webinar ser\u00e1 realizado em 24 de novembro, \u00e0s 15h (BRT) <\/strong>, e dever\u00e1 detalhar todas as medidas futuras. Registre-se aqui.<\/a><\/p>\n\n

A TGA aceitar\u00e1 as certifica\u00e7\u00f5es da UKCA<\/h2>\n\n

A Therapeutic Goods Administration (TGA), autoridade regulat\u00f3ria da Austr\u00e1lia, publicou uma atualiza\u00e7\u00e3o confirmando que come\u00e7ar\u00e1 a aceitar <\/a><\/strong>certifica\u00e7\u00f5es UKCA<\/strong><\/a> como parte do processo de avalia\u00e7\u00e3o de dispositivos m\u00e9dicos.<\/p>\n\n

Essa altera\u00e7\u00e3o expande os caminhos de equival\u00eancia regulamentar. Ela permite que os fabricantes certificados no Reino Unido usem essa base t\u00e9cnica para agilizar o acesso ao mercado australiano. <\/p>\n\n

Com essa nova aceita\u00e7\u00e3o, as empresas que operam em v\u00e1rios mercados podem estruturar seus portf\u00f3lios de forma mais eficiente, aproveitando as evid\u00eancias existentes.<\/strong><\/p>\n\n

Para os fabricantes que j\u00e1 possuem UKCA ou planejam obt\u00ea-lo, essa atualiza\u00e7\u00e3o \u00e9 uma oportunidade de acelerar o tempo de comercializa\u00e7\u00e3o na Austr\u00e1lia e otimizar sua estrat\u00e9gia de registro internacional.<\/p>\n\n

Grupo de trabalho publica rascunho da futura ISO\/TS 23485<\/h2>\n\n

O comit\u00ea t\u00e9cnico da ISO publicou o primeiro rascunho da ISO\/TS 23485<\/a><\/strong>, uma diretriz criada para apoiar a implementa\u00e7\u00e3o pr\u00e1tica da ISO 13485.<\/p>\n\n

Espera-se que o documento forne\u00e7a orienta\u00e7\u00e3o interpretativa, exemplos de pr\u00e1ticas recomendadas e instru\u00e7\u00f5es para os auditores, reduzindo as inconsist\u00eancias na forma como a norma \u00e9 aplicada.<\/p>\n\n

Para as empresas que dependem da ISO 13485 como base de seu sistema de qualidade, esse desenvolvimento \u00e9 especialmente relevante para auditorias e conformidade cont\u00ednua.<\/strong><\/p>\n\n

\"Equipe<\/figure>\n\n

Por que essas atualiza\u00e7\u00f5es importam<\/h2>\n\n

Em conjunto, esses an\u00fancios apontam para uma tend\u00eancia global de maior alinhamento regulat\u00f3rio e sistemas de gerenciamento de qualidade mais fortes.A harmoniza\u00e7\u00e3o da ISO 13485<\/strong> da FDA n\u00e3o \u00e9 apenas um ajuste t\u00e9cnico - ela sinaliza que as autoridades est\u00e3o buscando padronizar as expectativas e reduzir as discrep\u00e2ncias entre os mercados, tornando o ambiente regulat\u00f3rio mais previs\u00edvel.<\/p>\n\n

Ao mesmo tempo, iniciativas como o plano de redu\u00e7\u00e3o de atrasos da Anvisa, o reconhecimento da UKCA pela TGA e o desenvolvimento da ISO\/TS 23485 refor\u00e7am a necessidade de atualiza\u00e7\u00f5es cont\u00ednuas por parte das empresas.<\/p>\n\n

Qualquer pessoa que opere em mercados regulamentados deve acompanhar de perto essas mudan\u00e7as para garantir a conformidade e manter uma vantagem competitiva.<\/p>\n\n

E se voc\u00ea quiser receber essas atualiza\u00e7\u00f5es rapidamente, assine gratuitamente a Sobel News Round Up<\/strong><\/a> e receba as not\u00edcias regulat\u00f3rias que afetam sua empresa diretamente em sua caixa de entrada.<\/p>\n","protected":false},"excerpt":{"rendered":"

Confira as principais not\u00edcias regulat\u00f3rias da semana, incluindo a harmoniza\u00e7\u00e3o da ISO 13485 da FDA via QMSR, Anvisa e TGA.<\/p>\n","protected":false},"author":16,"featured_media":19986,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[308],"tags":[264,142,156,206,241],"class_list":["post-20665","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-pt-br","tag-anvisa-pt-br","tag-dispositivos-medicos","tag-fda-pt-br","tag-iso-pt-br","tag-qms-pt-br"],"yoast_head":"\nNot\u00edcias: Harmoniza\u00e7\u00e3o da ISO 13485 da FDA e outras atualiza\u00e7\u00f5es regulat\u00f3rias - Sobel<\/title>\n<meta name=\"description\" content=\"Confira as principais not\u00edcias regulat\u00f3rias da semana, incluindo a harmoniza\u00e7\u00e3o da ISO 13485 da FDA via QMSR, Anvisa e TGA.\" \/>\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-iso-13485-harmonization\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Not\u00edcias: Harmoniza\u00e7\u00e3o da ISO 13485 da FDA e outras atualiza\u00e7\u00f5es regulat\u00f3rias\" \/>\n<meta property=\"og:description\" content=\"Confira as principais not\u00edcias regulat\u00f3rias da semana, incluindo a harmoniza\u00e7\u00e3o da ISO 13485 da FDA via QMSR, Anvisa e TGA.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/fda-iso-13485-harmonization\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2025-11-21T11:43:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-11-21T12:57:52+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"733\" \/>\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\\\/fda-iso-13485-harmonization\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-iso-13485-harmonization\\\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/person\\\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Not\u00edcias: Harmoniza\u00e7\u00e3o da ISO 13485 da FDA e outras atualiza\u00e7\u00f5es regulat\u00f3rias\",\"datePublished\":\"2025-11-21T11:43:00+00:00\",\"dateModified\":\"2025-11-21T12:57:52+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-iso-13485-harmonization\\\/\"},\"wordCount\":745,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-iso-13485-harmonization\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2025\\\/11\\\/FDA-ISO-13485-harmonization.jpg\",\"keywords\":[\"Anvisa\",\"Dispositivos m\u00e9dicos\",\"FDA\",\"ISO\",\"QMS\"],\"articleSection\":[\"Not\u00edcias\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-iso-13485-harmonization\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/fda-iso-13485-harmonization\\\/\",\"name\":\"Not\u00edcias: Harmoniza\u00e7\u00e3o da ISO 13485 da FDA e outras atualiza\u00e7\u00f5es regulat\u00f3rias - 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