{"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":"2026-10-31T20:22:57","modified_gmt":"2026-10-31T23:22:57","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<p class=\"wp-block-paragraph\">A FDA publicou uma <strong>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<p class=\"wp-block-paragraph\">O objetivo \u00e9 <strong>alinhar<\/strong> ainda mais <strong>os requisitos da FDA com os princ\u00edpios da<\/strong> <strong>ISO 13485:2016<\/strong>, consolidando a harmoniza\u00e7\u00e3o entre as duas normas.<\/p>\n\n<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">Para as empresas que operam no mercado americano, esse movimento representa tanto um alerta quanto uma oportunidade estrat\u00e9gica.  <strong>Aqueles que se preparam com anteced\u00eancia reduzem os riscos e fortalecem sua posi\u00e7\u00e3o competitiva.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\"><strong>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). <strong>Envie-nos uma mensagem para receber mais informa\u00e7\u00f5es sobre nosso <a href=\"https:\/\/sobelconsult.com\/pt-br\/contact-us\/\">treinamento em ISO 13485<\/a>!<\/strong><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-anvisa-announces-plan-to-reduce-the-medical-device-backlog\"><strong>Anvisa anuncia plano para reduzir o atraso de dispositivos m\u00e9dicos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">A Anvisa anunciou <strong>um webinar para apresentar seu novo plano para reduzir as filas de an\u00e1lise relacionadas a dispositivos m\u00e9dicos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\"><strong>O webinar ser\u00e1 realizado em 24 de novembro, \u00e0s 15h (BRT) <\/strong>, e dever\u00e1 detalhar todas as medidas futuras. <a href=\"https:\/\/teams.microsoft.com\/l\/message\/19:6f6a02bf54584444825965ab9f82c550@thread.tacv2\/1763034581661?tenantId=963c8fe0-bdb7-427e-8c70-84fe98f4ccfa&amp;groupId=8b8b0509-8d45-4259-b2c7-b035d707a4d8&amp;parentMessageId=1763034581661&amp;teamName=Sobel%20Consultancy&amp;channelName=All%40Sobel&amp;createdTime=1763034581661\">Registre-se aqui.<\/a><\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-tga-to-accept-ukca-certifications\">A TGA aceitar\u00e1 as certifica\u00e7\u00f5es da UKCA<\/h2>\n\n<p class=\"wp-block-paragraph\">A Therapeutic Goods Administration (TGA), autoridade regulat\u00f3ria da Austr\u00e1lia, <strong>publicou uma <a href=\"https:\/\/www.legislation.gov.au\/F2025L01322\/asmade\/text\">atualiza\u00e7\u00e3o confirmando que come\u00e7ar\u00e1 a aceitar <\/a><\/strong><a href=\"https:\/\/www.legislation.gov.au\/F2025L01322\/asmade\/text\"><strong>certifica\u00e7\u00f5es UKCA<\/strong><\/a> como parte do processo de avalia\u00e7\u00e3o de dispositivos m\u00e9dicos.<\/p>\n\n<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">Com essa nova aceita\u00e7\u00e3o, <strong>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<p class=\"wp-block-paragraph\">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<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-iso-13485-harmonization\">Ver a consultoria para dispositivos m\u00e9dicos \u2192<\/a><\/p>\n<\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-working-group-publishes-draft-of-future-iso-ts-23485\">Grupo de trabalho publica rascunho da futura ISO\/TS 23485<\/h2>\n\n<p class=\"wp-block-paragraph\">O comit\u00ea t\u00e9cnico da ISO <strong>publicou o primeiro rascunho da <a href=\"https:\/\/www.iso.org\/standard\/90565.html\">ISO\/TS 23485<\/a><\/strong>, uma diretriz criada para apoiar a implementa\u00e7\u00e3o pr\u00e1tica da ISO 13485.<\/p>\n\n<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">Para as empresas que dependem da ISO 13485 como base de seu sistema de qualidade,<strong> esse desenvolvimento \u00e9 especialmente relevante para auditorias e conformidade cont\u00ednua.<\/strong><\/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\/2025\/07\/quality-control-for-medical-devices.webp\" alt=\"Equipe trabalhando no sistema de controle de qualidade. H&#xE1; tr&#xEA;s pessoas verificando gr&#xE1;ficos e dados. \" class=\"wp-image-10017\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/quality-control-for-medical-devices.webp 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/quality-control-for-medical-devices-300x200.webp 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/07\/quality-control-for-medical-devices-768x512.webp 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-why-these-updates-matter\">Por que essas atualiza\u00e7\u00f5es importam<\/h2>\n\n<p class=\"wp-block-paragraph\">Em conjunto, esses an\u00fancios apontam para uma tend\u00eancia global de maior alinhamento regulat\u00f3rio e sistemas de gerenciamento de qualidade mais fortes.<br\/><strong>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<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">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<p class=\"wp-block-paragraph\">E se voc\u00ea quiser receber essas atualiza\u00e7\u00f5es rapidamente, assine gratuitamente a <a href=\"https:\/\/sobelconsult.com\/pt-br\/?popup=810\"><strong>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":"<p>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":12,"featured_media":19986,"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":[529],"market":[501],"content_type":[517],"class_list":["post-20665","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivo-medico","tag-sistemas-da-qualidade-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) - 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