{"id":34965,"date":"2026-05-11T11:29:16","date_gmt":"2026-05-11T14:29:16","guid":{"rendered":"https:\/\/sobelconsult.com\/news-anvisa-regulatory-sandbox-and-global-updates\/"},"modified":"2026-05-12T05:56:43","modified_gmt":"2026-05-12T08:56:43","slug":"news-anvisa-regulatory-sandbox-and-global-updates","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/news-anvisa-regulatory-sandbox-and-global-updates\/","title":{"rendered":"Not\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais"},"content":{"rendered":"\n

A inova\u00e7\u00e3o, a vigil\u00e2ncia p\u00f3s-mercado e a evolu\u00e7\u00e3o das expectativas de conformidade est\u00e3o remodelando o cen\u00e1rio regulat\u00f3rio em todo o mundo. E, \u00e0 medida que as autoridades regulat\u00f3rias se adaptam \u00e0s novas tecnologias e demandas do mercado, os fabricantes devem ficar atentos \u00e0s mudan\u00e7as que podem afetar diretamente as estrat\u00e9gias de acesso ao mercado.<\/strong> <\/p>\n\n

Nesse contexto, a Anvisa deu um importante passo \u00e0 frente com sua nova iniciativa Sandbox Regulat\u00f3rio focada em cosm\u00e9ticos personalizados. Mas al\u00e9m do Brasil, h\u00e1 tamb\u00e9m atualiza\u00e7\u00f5es relevantes envolvendo a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o na China, discuss\u00f5es sobre os requisitos de MDR e IVDR na Europa<\/a> e altera\u00e7\u00f5es na ISO 10993-7. <\/p>\n\n

A seguir, reunimos os \u00faltimos destaques regulat\u00f3rios e explicamos por que eles merecem a aten\u00e7\u00e3o dos fabricantes.<\/p>\n\n

Anvisa avan\u00e7a com Sandbox Regulat\u00f3rio para cosm\u00e9ticos personalizados<\/strong><\/h2>\n\n

A Anvisa anunciou o resultado da etapa de sele\u00e7\u00e3o preliminar de seu Sandbox Regulat\u00f3rio<\/a><\/strong> voltado para produtos de higiene pessoal personalizados, cosm\u00e9ticos e fragr\u00e2ncias.<\/p>\n\n

Quatro projetos inovadores foram considerados eleg\u00edveis para passar para a pr\u00f3xima fase,<\/strong> que inclui uma avalia\u00e7\u00e3o t\u00e9cnica detalhada das propostas apresentadas pelas empresas participantes.<\/p>\n\n

A iniciativa faz parte do Ambiente Regulat\u00f3rio Experimental da Anvisa. Ele foi projetado para permitir que as empresas testem modelos de neg\u00f3cios inovadores sob condi\u00e7\u00f5es regulat\u00f3rias supervisionadas. <\/p>\n\n

O novo Sandbox Regulat\u00f3rio pode permitir que as empresas desenvolvam e testem solu\u00e7\u00f5es cosm\u00e9ticas personalizadas no ponto de venda. Essas atividades podem operar sob flexibilidades regulat\u00f3rias tempor\u00e1rias e protocolos personalizados. <\/p>\n\n

Esse movimento reflete uma tend\u00eancia crescente no setor de cosm\u00e9ticos: o aumento da demanda por personaliza\u00e7\u00e3o, digitaliza\u00e7\u00e3o e experi\u00eancias personalizadas do consumidor.<\/strong><\/p>\n\n

A China refor\u00e7a os requisitos de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o<\/strong><\/h2>\n\n

A China emitiu novas diretrizes que refor\u00e7am os requisitos de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o<\/a><\/strong> para dispositivos m\u00e9dicos.<\/p>\n\n

As regras atualizadas d\u00e3o maior \u00eanfase \u00e0s atividades de avalia\u00e7\u00e3o de risco e \u00e0s revis\u00f5es mais rigorosas dos relat\u00f3rios peri\u00f3dicos, aumentando as expectativas de conformidade para fabricantes locais e estrangeiros.<\/p>\n\n

Isso significa que as empresas que operam no mercado chin\u00eas podem precisar de sistemas de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o mais robustos, pr\u00e1ticas de documenta\u00e7\u00e3o mais fortes e monitoramento mais pr\u00f3ximo das obriga\u00e7\u00f5es regulat\u00f3rias locais.<\/p>\n\n

As atividades p\u00f3s-comercializa\u00e7\u00e3o est\u00e3o se tornando cada vez mais estrat\u00e9gicas para manter a conformidade e o acesso de longo prazo ao mercado.<\/p>\n\n

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

\u00d3rg\u00e3os Notificados levantam preocupa\u00e7\u00f5es sobre a revis\u00e3o do MDR e do IVDR<\/strong><\/h2>\n\n

A Equipe do NB expressou preocupa\u00e7\u00e3o com as revis\u00f5es propostas para as estruturas de MDR e IVDR na Europa<\/a>.<\/strong><\/p>\n\n

De acordo com a associa\u00e7\u00e3o, a redu\u00e7\u00e3o dos requisitos de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o poderia criar riscos regulat\u00f3rios e afetar potencialmente a seguran\u00e7a do paciente ao longo do tempo.<\/strong><\/p>\n\n

A discuss\u00e3o destaca como a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o continua sendo um dos pilares centrais do sistema regulat\u00f3rio europeu, especialmente no \u00e2mbito do MDR e do IVDR.<\/p>\n\n

Para os fabricantes, isso serve como um lembrete importante de que o cen\u00e1rio regulat\u00f3rio europeu continua a evoluir. Isso tamb\u00e9m exige um monitoramento constante das discuss\u00f5es legislativas e regulat\u00f3rias. <\/p>\n\n

A ISO 10993-7:2026 introduz atualiza\u00e7\u00f5es na avalia\u00e7\u00e3o biol\u00f3gica<\/strong><\/h2>\n\n

A Organiza\u00e7\u00e3o Internacional de Padroniza\u00e7\u00e3o atualizou oficialmente a ISO 10993-7:2026 com crit\u00e9rios revisados relacionados a res\u00edduos de esteriliza\u00e7\u00e3o<\/a>.<\/strong><\/p>\n\n

O padr\u00e3o atualizado introduz uma abordagem baseada em risco mais forte, levando em conta fatores como a popula\u00e7\u00e3o de pacientes e a dura\u00e7\u00e3o do uso ao definir os limites aceit\u00e1veis.<\/p>\n\n

Al\u00e9m disso, a nova vers\u00e3o oferece orienta\u00e7\u00e3o ampliada para o lan\u00e7amento de produtos e metodologias de avalia\u00e7\u00e3o.<\/p>\n\n

Essa atualiza\u00e7\u00e3o refor\u00e7a a expectativa crescente de que os fabricantes forne\u00e7am justificativas cient\u00edficas mais robustas em todas as atividades de avalia\u00e7\u00e3o biol\u00f3gica e processos de gerenciamento de risco.<\/p>\n\n

Dica: <\/strong>a avalia\u00e7\u00e3o biol\u00f3gica geralmente gera d\u00favidas entre os fabricantes, principalmente quando comparada \u00e0s avalia\u00e7\u00f5es cl\u00ednicas e toxicol\u00f3gicas. Em nossa \u00faltima publica\u00e7\u00e3o no blog, explicamos as diferen\u00e7as entre essas avalia\u00e7\u00f5es<\/a>, como elas se relacionam entre si e por que s\u00e3o essenciais em todo o processo regulat\u00f3rio.<\/strong> <\/p>\n\n

Inova\u00e7\u00e3o, vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o e adapta\u00e7\u00e3o regulat\u00f3ria<\/strong><\/h2>\n\n

Toda semana, as autoridades reguladoras de todo o mundo introduzem atualiza\u00e7\u00f5es que podem afetar diretamente os fabricantes dos setores de dispositivos m\u00e9dicos, IVD e cosm\u00e9ticos.<\/p>\n\n

Desde o avan\u00e7o do Sandbox Regulat\u00f3rio no Brasil at\u00e9 requisitos mais r\u00edgidos de vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o e padr\u00f5es internacionais em evolu\u00e7\u00e3o, essas mudan\u00e7as refor\u00e7am como as estrat\u00e9gias regulat\u00f3rias devem se adaptar continuamente \u00e0s expectativas de inova\u00e7\u00e3o e conformidade global.<\/p>\n\n

Mais do que nunca, manter-se informado \u00e9 essencial para reduzir riscos, evitar atrasos e manter a competitividade em mercados regulamentados cada vez mais complexos.<\/p>\n\n

Voc\u00ea quer ficar por dentro das mudan\u00e7as no setor e das atualiza\u00e7\u00f5es regulat\u00f3rias? Assine nosso boletim informativo. Cadastre-se clicando no bot\u00e3o abaixo!<\/strong><\/p>\n\n

\n
Receba as not\u00edcias!<\/strong><\/a><\/div>\n<\/div>\n\n

Permita que as informa\u00e7\u00f5es ajudem a reduzir riscos, evitar retrabalho e manter a competitividade!<\/p>\n","protected":false},"excerpt":{"rendered":"

A Anvisa avan\u00e7a em sua iniciativa Sandbox Regulat\u00f3rio para cosm\u00e9ticos personalizados, enquanto os reguladores globais fortalecem a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.<\/p>\n","protected":false},"author":16,"featured_media":34960,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[308],"tags":[264,297,329,142,128,206,309],"class_list":["post-34965","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-noticias-pt-br","tag-anvisa-pt-br","tag-brasil","tag-china-pt-br","tag-dispositivos-medicos","tag-europa-pt-br","tag-iso-pt-br","tag-noticias-pt-br"],"yoast_head":"\nNot\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais - Sobel<\/title>\n<meta name=\"description\" content=\"A Anvisa avan\u00e7a em sua iniciativa Sandbox Regulat\u00f3rio para cosm\u00e9ticos personalizados, enquanto os reguladores globais fortalecem a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.\" \/>\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\/news-anvisa-regulatory-sandbox-and-global-updates\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Not\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais\" \/>\n<meta property=\"og:description\" content=\"A Anvisa avan\u00e7a em sua iniciativa Sandbox Regulat\u00f3rio para cosm\u00e9ticos personalizados, enquanto os reguladores globais fortalecem a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/sobelconsult.com\/pt-br\/news-anvisa-regulatory-sandbox-and-global-updates\/\" \/>\n<meta property=\"og:site_name\" content=\"Sobel\" \/>\n<meta property=\"article:published_time\" content=\"2026-05-11T14:29:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-05-12T08:56:43+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2026\/05\/cosmetic-test.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\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=\"5 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\"},\"author\":{\"name\":\"Bruna Marzarotto\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#\\\/schema\\\/person\\\/bd2753d272a36eb353492e956e803d3b\"},\"headline\":\"Not\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais\",\"datePublished\":\"2026-05-11T14:29:16+00:00\",\"dateModified\":\"2026-05-12T08:56:43+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\"},\"wordCount\":919,\"publisher\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/sobelconsult.com\\\/wp-content\\\/uploads\\\/2026\\\/05\\\/cosmetic-test.jpg\",\"keywords\":[\"Anvisa\",\"Brasil\",\"China\",\"Dispositivos m\u00e9dicos\",\"Europa\",\"ISO\",\"Not\u00edcias\"],\"articleSection\":[\"Not\u00edcias\"],\"inLanguage\":\"pt-BR\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\",\"url\":\"https:\\\/\\\/sobelconsult.com\\\/pt-br\\\/news-anvisa-regulatory-sandbox-and-global-updates\\\/\",\"name\":\"Not\u00edcias: Sandbox Regulat\u00f3rio da Anvisa e Atualiza\u00e7\u00f5es Globais - 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