{"id":32694,"date":"2026-02-27T14:41:01","date_gmt":"2026-02-27T17:41:01","guid":{"rendered":"https:\/\/sobelconsult.com\/news-uk-regulatory-authority-launches-consultation-on-ce-marking\/"},"modified":"2026-02-27T14:41:42","modified_gmt":"2026-02-27T17:41:42","slug":"news-uk-regulatory-authority-launches-consultation-on-ce-marking","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/news-uk-regulatory-authority-launches-consultation-on-ce-marking\/","title":{"rendered":"Not\u00edcias: Autoridade reguladora do Reino Unido lan\u00e7a consulta sobre a marca\u00e7\u00e3o CE"},"content":{"rendered":"\n

O cen\u00e1rio regulat\u00f3rio internacional continua a evoluir e, desta vez, o foco est\u00e1 na autoridade regulat\u00f3ria do Reino Unido.<\/strong><\/p>\n\n

A MHRA lan\u00e7ou uma consulta p\u00fablica que pode reformular as estrat\u00e9gias de acesso ao mercado na Gr\u00e3-Bretanha para fabricantes de dispositivos m\u00e9dicos e IVDs que possuem a marca\u00e7\u00e3o CE<\/a>.<\/p>\n\n

Ao mesmo tempo, as atualiza\u00e7\u00f5es no Brasil e nos Estados Unidos refor\u00e7am uma tend\u00eancia global: a previsibilidade regulat\u00f3ria, a simplifica\u00e7\u00e3o operacional e a supervis\u00e3o refor\u00e7ada permanecem no centro das discuss\u00f5es regulat\u00f3rias.<\/p>\n\n

Neste artigo, descrevemos os principais desenvolvimentos que podem afetar<\/strong> o planejamento regulat\u00f3rio das empresas que operam internacionalmente.<\/p>\n\n

A autoridade reguladora do Reino Unido e o reconhecimento da marca CE<\/strong><\/h2>\n\n

A autoridade regulat\u00f3ria do Reino Unido (MHRA) abriu uma consulta propondo o reconhecimento reconhecimento indefinido dos dispositivos m\u00e9dicos com a marca CE<\/strong><\/a> no mercado da Gr\u00e3-Bretanha.<\/strong><\/p>\n\n

A proposta vem em resposta direta \u00e0s incertezas p\u00f3s-Brexit e \u00e0s solicita\u00e7\u00f5es recorrentes do setor por maior estabilidade na estrutura de acesso ao mercado do Reino Unido.<\/p>\n\n

Atualmente, uma parte significativa dos dispositivos comercializados na Gr\u00e3-Bretanha ainda depende da certifica\u00e7\u00e3o CE, enquanto o modelo UKCA ainda n\u00e3o foi totalmente consolidado como padr\u00e3o exclusivo.<\/strong><\/p>\n\n

A consulta inclui tr\u00eas propostas principais:<\/p>\n\n

- Possibilidade de reconhecimento cont\u00ednuo da marca\u00e7\u00e3o CE<\/p>\n\n

- Prorroga\u00e7\u00e3o dos prazos de transi\u00e7\u00e3o para dispositivos certificados de acordo com a MDD at\u00e9 dezembro de 2028<\/p>\n\n

- Cria\u00e7\u00e3o de uma rota de reconhecimento internacional para dispositivos classificados como de alto risco de acordo com as regulamenta\u00e7\u00f5es do Reino Unido<\/p>\n\n

Se aprovadas, essas propostas poder\u00e3o reduzir os custos imediatos de transi\u00e7\u00e3o<\/strong> e permitir um planejamento regulat\u00f3rio mais estrat\u00e9gico.<\/p>\n\n

Por outro lado, a proposta tamb\u00e9m sinaliza poss\u00edveis mudan\u00e7as na din\u00e2mica da supervis\u00e3o. Certos dispositivos poderiam ser aceitos sem a an\u00e1lise pr\u00e9-mercado do Reino Unido, mas continuariam a ser monitorados pelas estruturas regulat\u00f3rias europeias. <\/p>\n\n

Para empresas que operam no Reino Unido ou planejam expans\u00e3o, acompanhar de perto as pr\u00f3ximas etapas da autoridade reguladora do Reino Unido \u00e9 essencial para decis\u00f5es de investimento, prioriza\u00e7\u00e3o de mercado e gerenciamento de riscos regulat\u00f3rios.<\/p>\n\n

\"Marcação<\/figure>\n\n

Anvisa simplifica o processo de certifica\u00e7\u00e3o GMP para dispositivos m\u00e9dicos<\/strong><\/h2>\n\n

No Brasil, a Anvisa anunciou a unifica\u00e7\u00e3o dos c\u00f3digos de assunto usados na solicita\u00e7\u00e3o do Certificado de Boas Pr\u00e1ticas de Fabrica\u00e7\u00e3o (CBPF) para dispositivos m\u00e9dicos.<\/strong><\/a> para dispositivos m\u00e9dicos.<\/p>\n\n

Embora a medida n\u00e3o altere os requisitos estabelecidos na RDC 497\/2021, ela simplifica os fluxos de trabalho operacionais no sistema Solicita.<\/p>\n\n

A separa\u00e7\u00e3o entre as linhas de produ\u00e7\u00e3o de dispositivos m\u00e9dicos e IVD continua obrigat\u00f3ria, mas o processo administrativo se torna mais simplificado.<\/p>\n\n

Nas \u00faltimas semanas, a Anvisa tamb\u00e9m participou de <\/strong>miss\u00f5es oficiais \u00e0 \u00cdndia<\/strong><\/a> e em v\u00e1rios <\/strong>pa\u00edses africanos<\/strong><\/a>.<\/strong> O objetivo \u00e9 fortalecer o di\u00e1logo regulat\u00f3rio e ampliar a coopera\u00e7\u00e3o nas \u00e1reas de sa\u00fade, dispositivos m\u00e9dicos, produtos farmac\u00eauticos e cosm\u00e9ticos.<\/p>\n\n

Esse tipo de movimento sinaliza um impulso para uma maior integra\u00e7\u00e3o internacional. No longo prazo, pode influenciar os processos de harmoniza\u00e7\u00e3o regulat\u00f3ria e as oportunidades comerciais. <\/p>\n\n

A FDA refor\u00e7a os requisitos de renova\u00e7\u00e3o bienal de acordo com o MoCRA<\/strong><\/h2>\n\n

Nos Estados Unidos, <\/strong>a FDA atualizou o portal Cosmetics Direct<\/strong><\/a> e os materiais de orienta\u00e7\u00e3o relacionados<\/strong> para apoiar a renova\u00e7\u00e3o bienal dos registros de instala\u00e7\u00f5es de cosm\u00e9ticos, conforme exigido pelo MoCRA.<\/p>\n\n

As atualiza\u00e7\u00f5es incluem lembretes autom\u00e1ticos, visibilidade do status do registro e instru\u00e7\u00f5es de envio revisadas.<\/strong><\/p>\n\n

Essa iniciativa refor\u00e7a a consolida\u00e7\u00e3o da nova estrutura regulat\u00f3ria para cosm\u00e9ticos no mercado dos EUA, com maior rastreabilidade e supervis\u00e3o formal dos registros das instala\u00e7\u00f5es.<\/p>\n\n

As empresas que operam no setor devem monitorar cuidadosamente seus prazos, pois a renova\u00e7\u00e3o deve ocorrer a cada dois anos a partir da data do registro inicial.<\/p>\n\n

Monitoramento como ferramenta estrat\u00e9gica<\/strong><\/h2>\n\n

As iniciativas da autoridade regulat\u00f3ria do Reino Unido, combinadas com as atualiza\u00e7\u00f5es da Anvisa e da FDA, demonstram que o ambiente regulat\u00f3rio global continua a evoluir.<\/p>\n\n

Para as empresas que operam em v\u00e1rios mercados, o monitoramento ativo dessas mudan\u00e7as deve fazer parte da estrat\u00e9gia corporativa, n\u00e3o apenas como um requisito de conformidade, mas como uma vantagem competitiva.<\/p>\n\n

Entender o que cada autoridade reguladora sinaliza hoje pode se traduzir em economia de custos, redu\u00e7\u00e3o de riscos e maior previsibilidade no futuro.<\/p>\n\n

Para se manter informado, recomendamos que voc\u00ea assine gratuitamente o Sobel News Round Up<\/a>.<\/p>\n\n

Ao fazer isso, voc\u00ea receber\u00e1 em sua caixa de entrada os principais desenvolvimentos regulat\u00f3rios de todo o mundo, seja da autoridade reguladora do Reino Unido, do Brasil ou de seus mercados-alvo.<\/p>\n","protected":false},"excerpt":{"rendered":"

A autoridade reguladora do Reino Unido abre uma consulta sobre o reconhecimento da marca CE e destaca outras atualiza\u00e7\u00f5es regulat\u00f3rias globais importantes.<\/p>\n","protected":false},"author":16,"featured_media":6427,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[308],"tags":[264,297,142,128,400,309,399],"class_list":["post-32694","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-mhra","tag-noticias-pt-br","tag-reino-unido"],"yoast_head":"\nNot\u00edcias: Autoridade reguladora do Reino Unido lan\u00e7a consulta sobre a marca\u00e7\u00e3o CE - Sobel<\/title>\n<meta name=\"description\" content=\"A autoridade reguladora do Reino Unido abre uma consulta sobre o reconhecimento da marca CE e destaca outras atualiza\u00e7\u00f5es regulat\u00f3rias 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