{"id":33916,"date":"2026-04-10T09:24:17","date_gmt":"2026-04-10T12:24:17","guid":{"rendered":"https:\/\/sobelconsult.com\/mdr-ivdr-revision-unique-device-identification-codes\/"},"modified":"2026-10-31T20:23:22","modified_gmt":"2026-10-31T23:23:22","slug":"mdr-ivdr-revision-unique-device-identification-codes","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/mdr-ivdr-revision-unique-device-identification-codes\/","title":{"rendered":"Not\u00edcias: Revis\u00e3o de MDR\/IVDR e c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos na China"},"content":{"rendered":"\n

As autoridades regulat\u00f3rias de todo o mundo est\u00e3o buscando maior previsibilidade, transpar\u00eancia e harmoniza\u00e7\u00e3o<\/strong>. Como resultado, as mudan\u00e7as regulat\u00f3rias na Europa - como a revis\u00e3o do MDR\/IVDR - e a implementa\u00e7\u00e3o de c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos (UDI) na China est\u00e3o ocorrendo simultaneamente. <\/p>\n\n

Para os profissionais que atuam no setor de dispositivos m\u00e9dicos, manter-se atualizado faz toda a diferen\u00e7a. Este artigo foi criado com esse objetivo: manter voc\u00ea informado sobre os desenvolvimentos regulat\u00f3rios mais relevantes das \u00faltimas semanas. <\/p>\n\n

Dica: <\/strong>quem assina nossa newsletter recebe todo esse conte\u00fado com anteced\u00eancia. N\u00e3o fique de fora: inscreva-segratuitamente para receber a <\/strong>Sobel News Round Up<\/strong><\/a>.<\/strong> <\/p>\n\n

Uni\u00e3o Europeia sinaliza progresso nas revis\u00f5es de MDR e IVDR<\/h2>\n\n

As autoridades da Uni\u00e3o Europeia expressaram otimismo<\/strong> em rela\u00e7\u00e3o \u00e0s revis\u00f5es propostas para o Regulamento de Dispositivos M\u00e9dicos (MDR) e o Regulamento de Diagn\u00f3stico In Vitro (IVDR).<\/a><\/p>\n\n

As discuss\u00f5es se concentram nos conhecidos desafios de implementa\u00e7\u00e3o desde que os regulamentos entraram em vigor. Os principais problemas incluem a capacidade limitada do \u00f3rg\u00e3o notificado, cronogramas de transi\u00e7\u00e3o desafiadores e a carga administrativa significativa imposta aos fabricantes. <\/p>\n\n

Embora as propostas ainda estejam sendo avaliadas, o sinal positivo sugere abertura para ajustes com base na experi\u00eancia real do setor,<\/strong> sem comprometer os requisitos de seguran\u00e7a e desempenho dos dispositivos.<\/p>\n\n

Voc\u00ea fabrica dispositivos m\u00e9dicos e planeja acessar o mercado europeu<\/a>? Ent\u00e3o fique atento e reavalie suas estrat\u00e9gias regulat\u00f3rias. <\/p>\n\n

China estabelece prazo final para conformidade total com UDI<\/h2>\n\n

Voc\u00ea j\u00e1 ouviu falar do acr\u00f4nimo UDI? Ela se refere a c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos<\/strong>, um sistema projetado para permitir o controle e a rastreabilidade de produtos m\u00e9dicos.<\/p>\n\n

Os requisitos de UDI j\u00e1 est\u00e3o sendo implementados em v\u00e1rios pa\u00edses.<\/strong> Na China, as autoridades anunciaram que todos os dispositivos m\u00e9dicos devem estar totalmente em conformidade com os requisitos de UDI at\u00e9 2029<\/a>.<\/p>\n\n

Essa medida fortalece a rastreabilidade durante todo o ciclo de vida do produto, melhora a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o e alinha a China mais de perto com as pr\u00e1ticas regulat\u00f3rias internacionais.<\/p>\n\n

Al\u00e9m disso, a exig\u00eancia aumenta a relev\u00e2ncia dos c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos como um elemento central para controle regulat\u00f3rio, log\u00edstica, recalls e monitoramento de seguran\u00e7a.<\/strong><\/p>\n\n

As empresas que operam no mercado chin\u00eas ou planejam entrar nele devem incorporar esse requisito em suas estrat\u00e9gias regulat\u00f3rias o mais cedo poss\u00edvel.<\/p>\n\n

Dica: se a sua empresa est\u00e1 pensando em expandir as opera\u00e7\u00f5es e levar produtos para a China, um dos maiores mercados do mundo, conte com a Sobel!<\/strong><\/p>\n\n

Temos especialistas totalmente dedicados \u00e0s opera\u00e7\u00f5es regulat\u00f3rias na China, ajudando os fabricantes a navegar por esses processos com maior efici\u00eancia e confian\u00e7a.<\/p>\n\n

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

H2: Anvisa lan\u00e7a painel de monitoramento para a Agenda Regulat\u00f3ria 2026-2027<\/strong><\/p>\n\n

No Brasil, a Anvisa lan\u00e7ou um painel de controle p\u00fablico para monitorar suas <\/strong>Agenda Regulat\u00f3ria 2026-2027<\/strong><\/a>.<\/strong><\/p>\n\n

A ferramenta oferece maior visibilidade das a\u00e7\u00f5es planejadas, cronogramas e prioridades regulat\u00f3rias.<\/strong> Na pr\u00e1tica, fortalece a transpar\u00eancia e permite um planejamento mais estrat\u00e9gico para as empresas.<\/p>\n\n

Outro desenvolvimento importante \u00e9 a assinatura da Declara\u00e7\u00e3o do Rio de Janeiro pela Anvisa<\/strong>, juntamente com v\u00e1rias autoridades reguladoras da Am\u00e9rica Latina.<\/p>\n\n

Esse marco representa um compromisso com a converg\u00eancia regulat\u00f3ria.<\/strong> A iniciativa busca aprimorar a coopera\u00e7\u00e3o entre as ag\u00eancias, simplificar os processos e facilitar o acesso ao mercado em toda a regi\u00e3o.<\/p>\n\n

Al\u00e9m disso, espera-se que ele promova o alinhamento dos requisitos t\u00e9cnicos e administrativos, incluindo aqueles relacionados aos c\u00f3digos de identifica\u00e7\u00e3o exclusivos dos dispositivos.<\/p>\n\n

\n

Dispositivos m\u00e9dicos<\/p>\n\n\n\n

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

Ver a consultoria para dispositivos m\u00e9dicos \u2192<\/a><\/p>\n<\/div>\n\n\n\n

Uma nova ferramenta no site da Sobel<\/h2>\n\n

Voc\u00ea deseja regularizar um dispositivo m\u00e9dico, cosm\u00e9tico ou IVD, mas n\u00e3o tem certeza de qual servi\u00e7o precisa?<\/strong><\/p>\n\n

A Sobel tem a solu\u00e7\u00e3o para voc\u00ea! Lan\u00e7amos uma nova ferramenta em nosso site<\/strong> criada para orientar voc\u00ea em sua jornada regulat\u00f3ria.<\/p>\n\n

Funciona assim: clicando no bot\u00e3o de bate-papo na parte inferior do site (ou acessando a ferramenta diretamente<\/a>), voc\u00ea responder\u00e1 a algumas perguntas.<\/p>\n\n

Ao final, a tela exibe os servi\u00e7os recomendados para o seu caso<\/strong>, juntamente com a op\u00e7\u00e3o de ser contatado por nossa equipe de especialistas.<\/p>\n\n

Trata-se de um recurso pr\u00e1tico e altamente funcional que ajudar\u00e1 voc\u00ea a identificar o melhor caminho para o seu processo regulat\u00f3rio.<\/p>\n\n

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

O que essas mudan\u00e7as significam para sua empresa?<\/h2>\n\n

Como voc\u00ea viu, muitos pa\u00edses est\u00e3o tomando medidas importantes em suas estruturas regulat\u00f3rias.<\/p>\n\n

Em conjunto, essas iniciativas refletem um esfor\u00e7o global em dire\u00e7\u00e3o a sistemas regulat\u00f3rios mais previs\u00edveis, integrados e focados na seguran\u00e7a do paciente.<\/p>\n\n

Por isso, manter-se informado \u00e9 essencial. Isso contribui para a tomada de decis\u00f5es estrat\u00e9gicas mais seguras, seja para submiss\u00f5es regulat\u00f3rias ou para a implementa\u00e7\u00e3o de c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos em diferentes mercados. <\/p>\n\n

A antecipa\u00e7\u00e3o das tend\u00eancias regulat\u00f3rias permite que as empresas ajustem seus roteiros, otimizem recursos e fortale\u00e7am a competitividade em um ambiente cada vez mais regulamentado e interconectado.<\/p>\n","protected":false},"excerpt":{"rendered":"

Al\u00e9m da revis\u00e3o do MDR\/IVDR, os c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos na China receberam um prazo final. Saiba mais. <\/p>\n","protected":false},"author":12,"featured_media":33905,"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":[138,263],"tags":[541],"market":[497],"content_type":[517],"class_list":["post-33916","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivo-medico","category-ivd-pt-br","tag-udi-e-eudamed-pt-br","market-europa","content_type-noticias"],"yoast_head":"\nNot\u00edcias: Revis\u00e3o de MDR\/IVDR e c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos na China - Sobel<\/title>\n<meta name=\"description\" content=\"Al\u00e9m da revis\u00e3o do MDR\/IVDR, os c\u00f3digos exclusivos de identifica\u00e7\u00e3o de dispositivos na China receberam um prazo final. 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