{"id":33044,"date":"2026-03-13T08:47:12","date_gmt":"2026-03-13T11:47:12","guid":{"rendered":"https:\/\/sobelconsult.com\/news-imdrf-publishes-regulatory-reliance-playbook\/"},"modified":"2026-03-16T16:02:40","modified_gmt":"2026-03-16T19:02:40","slug":"news-imdrf-publica-regulatory-reliance-playbook","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/news-imdrf-publica-regulatory-reliance-playbook\/","title":{"rendered":"News: IMDRF publica Regulatory Reliance Playbook"},"content":{"rendered":"\n<p>O ambiente regulat\u00f3rio para dispositivos m\u00e9dicos tem passado por ajustes relevantes em diferentes mercados. Em meio a esse cen\u00e1rio, cresce a aten\u00e7\u00e3o para abordagens que permitam \u00e0s ag\u00eancias sanit\u00e1rias utilizar avalia\u00e7\u00f5es j\u00e1 realizadas por autoridades de refer\u00eancia, sem abrir m\u00e3o da responsabilidade regulat\u00f3ria local \u2013 a chamada regulatory reliance. <\/p>\n\n<p>Movimentos recentes do F\u00f3rum Internacional de Reguladores de Dispositivos M\u00e9dicos (IMDRF), somados a atualiza\u00e7\u00f5es da FDA, da Anvisa e de autoridades regulat\u00f3rias na \u00c1sia, evidenciam como essa l\u00f3gica vem sendo incorporada de forma pr\u00e1tica \u00e0s discuss\u00f5es regulat\u00f3rias globais.<\/p>\n\n<p>Em um segmento em constante mudan\u00e7a, acompanhar essas iniciativas \u00e9 fundamental para alinhar estrat\u00e9gias regulat\u00f3rias, antecipar impactos e reduzir incertezas.<\/p>\n\n<p>A seguir, confira as principais novidades do segmento regulat\u00f3rio das \u00faltimas semanas.<\/p>\n\n<p><strong>Dica:<\/strong> quem se inscreve na <a href=\"https:\/\/sobelconsult.com\/?popup=810\"><em>Sobel News Round Up,<\/em><\/a> a nossa newsletter gratuita, j\u00e1 sabe de todas essas informa\u00e7\u00f5es porque recebe primeiro. Se inscreva tamb\u00e9m! <\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-imdrf-and-regulatory-reliance\">IMDRF e Regulatory Reliance<\/h2>\n\n<p>Primeiramente, \u00e9 importante entendermos o conceito de Regulatory Reliance.<\/p>\n\n<p>Regulatory reliance \u00e9 a pr\u00e1tica pela qual uma autoridade regulat\u00f3ria considera e utiliza, total ou parcialmente, avalia\u00e7\u00f5es realizadas por outras autoridades consideradas confi\u00e1veis, mantendo, ainda assim, a responsabilidade pela decis\u00e3o final em sua pr\u00f3pria jurisdi\u00e7\u00e3o.<\/p>\n\n<p>Essa abordagem busca evitar a duplica\u00e7\u00e3o de esfor\u00e7os regulat\u00f3rios, promover o uso mais racional de recursos e acelerar processos de avalia\u00e7\u00e3o, sem comprometer a seguran\u00e7a, a efic\u00e1cia e o desempenho dos produtos.<\/p>\n\n<p>O regulatory reliance pode assumir diferentes formatos, como revis\u00f5es abreviadas, reconhecimento de decis\u00f5es estrangeiras ou modelos de trabalho compartilhado entre autoridades.<\/p>\n\n<p>Embora o conceito n\u00e3o seja novo, sua ado\u00e7\u00e3o tem ganhado for\u00e7a nos \u00faltimos anos diante do aumento da complexidade tecnol\u00f3gica dos dispositivos m\u00e9dicos.<\/p>\n\n<p>Mas onde entra o IMDRF nisso?<\/p>\n\n<p>No final de fevereiro de 2026, o IMDRF (International Medical Device Regulators Forum) publicou o <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/2\/imdrf-publishes-regulatory-reliance-playbook-docum\"><em>Playbook for Medical Device Regulatory Reliance Programs.<\/em><\/a><\/p>\n\n<p>Esse documento oferece orienta\u00e7\u00f5es pr\u00e1ticas para autoridades regulat\u00f3rias interessadas em desenvolver ou aprimorar programas formais de regulatory reliance para dispositivos m\u00e9dicos e diagn\u00f3sticos in vitro.<\/p>\n\n<p>Desenvolvido pelo grupo de trabalho de Boas Pr\u00e1ticas de Revis\u00e3o Regulat\u00f3ria (GRRP), o playbook consolida defini\u00e7\u00f5es, apresenta exemplos de modelos j\u00e1 existentes e descreve etapas pr\u00e1ticas para implementa\u00e7\u00e3o de programas baseados em regulatory reliance, sempre refor\u00e7ando a independ\u00eancia e a responsabilidade decis\u00f3ria das autoridades envolvidas.<\/p>\n\n<p>Para fabricantes, isso representa uma mudan\u00e7a relevante no ambiente regulat\u00f3rio, com potencial impacto em prazos de aprova\u00e7\u00e3o, estrat\u00e9gias de submiss\u00e3o e prioriza\u00e7\u00e3o de mercados.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-updates-reinforcing-the-global-trend\">Atualiza\u00e7\u00f5es regulat\u00f3rias que refor\u00e7am a tend\u00eancia global<\/h2>\n\n<p>Al\u00e9m da iniciativa do IMDRF, outros movimentos recentes refor\u00e7am a busca por maior efici\u00eancia e previsibilidade regulat\u00f3ria.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-core-functions-and-priorities-at-the-fda\">Fun\u00e7\u00f5es centrais e prioridades na FDA<\/h3>\n\n<p>Nos Estados Unidos, a FDA confirmou que as <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/3\/fda-official-core-inspectional-functions,-prioriti\">fun\u00e7\u00f5es centrais e as prioridades de seu programa de inspe\u00e7\u00f5es permanecem inalteradas<\/a>, mesmo diante de mudan\u00e7as recentes na lideran\u00e7a.<\/p>\n\n<p>Ou seja, a ag\u00eancia seguir\u00e1 focada em inspe\u00e7\u00f5es baseadas em risco, inspe\u00e7\u00f5es pr\u00e9\u2011aprova\u00e7\u00e3o e a\u00e7\u00f5es de vigil\u00e2ncia, incluindo atividades em instala\u00e7\u00f5es internacionais.<\/p>\n\n<figure class=\"wp-block-image aligncenter size-large\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"684\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-1024x684.jpg\" alt=\"Um profissional est&#xE1; trabalhando em documentos em uma mesa. Os documentos est&#xE3;o em uma prancheta, onde m&#xE3;os femininas seguram uma caneta, como se estivessem analisando as informa&#xE7;&#xF5;es. Ao fundo, voc&#xEA; pode ver materiais de escrit&#xF3;rio e uma bandeira americana.  \" class=\"wp-image-25556\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-1024x684.jpg 1024w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-300x200.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration-768x513.jpg 768w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/01\/us-agent-FDA-registration.jpg 1294w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n\n<p>Esse posicionamento refor\u00e7a a import\u00e2ncia de <a href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/sistema-da-qualidade-fda\/\">sistemas de qualidade robustos<\/a> e de uma postura cont\u00ednua de conformidade por parte das empresas.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-udi-system-goes-live-in-brazil\">Entra em opera\u00e7\u00e3o Siud no Brasil<\/h3>\n\n<p>No Brasil, a Anvisa <a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2026\/entra-em-operacao-sistema-que-traz-mais-seguranca-para-dispositivos-medicos-no-brasil\">colocou em opera\u00e7\u00e3o o Sistema de Identifica\u00e7\u00e3o \u00danica de Dispositivos M\u00e9dicos (Siud)<\/a>, alinhado \u00e0s diretrizes do IMDRF.<\/p>\n\n<p>A iniciativa fortalece a rastreabilidade e a vigil\u00e2ncia p\u00f3s\u2011mercado, aproximando o pa\u00eds de pr\u00e1ticas regulat\u00f3rias adotadas internacionalmente e ampliando a transpar\u00eancia ao longo da cadeia de suprimentos.<\/p>\n\n<h3 class=\"wp-block-heading\" id=\"h-malaysia-updates-rules-for-medical-device-purchases\">Mal\u00e1sia atualiza regras para compras de dispositivos m\u00e9dicos<\/h3>\n\n<p>Na \u00c1sia, a autoridade reguladora da Mal\u00e1sia publicou <a href=\"https:\/\/cisema.com\/en\/malaysia-medical-device-procurement\/\">novas regras para a aquisi\u00e7\u00e3o de dispositivos m\u00e9dicos<\/a> por hospitais e institui\u00e7\u00f5es de sa\u00fade. .<\/p>\n\n<p>As normas esclarecem que fornecedores envolvidos em processos de compra p\u00fablica ou privada devem cumprir integralmente os requisitos regulat\u00f3rios locais, incluindo licenciamento adequado, refor\u00e7ando o papel da regula\u00e7\u00e3o tamb\u00e9m nas etapas de comercializa\u00e7\u00e3o.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-regulatory-monitoring-as-a-competitive-advantage\">Monitoramento regulat\u00f3rio como vantagem competitiva<\/h2>\n\n<p>As iniciativas recentes do IMDRF, da FDA, da Anvisa e de autoridades regulat\u00f3rias asi\u00e1ticas deixam claro que o ambiente regulat\u00f3rio global est\u00e1 em constante transforma\u00e7\u00e3o. Para empresas do setor de dispositivos m\u00e9dicos, acompanhar essas mudan\u00e7as n\u00e3o deve ser visto apenas como uma obriga\u00e7\u00e3o de compliance, mas como uma ferramenta estrat\u00e9gica.<\/p>\n\n<p>Entender como conceitos como regulatory reliance est\u00e3o sendo incorporados aos marcos regulat\u00f3rios pode ajudar empresas a antecipar cen\u00e1rios, reduzir riscos, otimizar investimentos e tomar decis\u00f5es mais assertivas sobre expans\u00e3o internacional.<\/p>\n\n<p>Por isso, manter-se informado sobre esses movimentos \u00e9 o que faz a diferen\u00e7a na sua pr\u00f3xima estrat\u00e9gia regulat\u00f3ria.<\/p>\n\n<p>E lembre-se: o <a href=\"https:\/\/sobelconsult.com\/pt-br\/#footer-cta\">time Sobel est\u00e1 dispon\u00edvel para orientar voc\u00ea<\/a> em jornadas de regulat\u00f3rias globais!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Entenda o conceito de regulatory reliance e como iniciativas do IMDRF, FDA e Anvisa est\u00e3o impactando a regula\u00e7\u00e3o global.<\/p>\n","protected":false},"author":16,"featured_media":33040,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[308],"tags":[264,297,142,128,156,309],"class_list":["post-33044","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-pt-br","tag-anvisa-pt-br","tag-brasil","tag-dispositivos-medicos","tag-europa-pt-br","tag-fda-pt-br","tag-noticias-pt-br"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v26.3 (Yoast SEO v26.8) - 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