{"id":8281,"date":"2025-05-12T17:47:54","date_gmt":"2025-05-12T16:47:54","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=8281"},"modified":"2025-05-12T17:47:54","modified_gmt":"2025-05-12T16:47:54","slug":"anvisa-marco-regulatorio-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/anvisa-marco-regulatorio-dispositivos-medicos\/","title":{"rendered":"Anvisa promove consulta dirigida sobre novo marco regulat\u00f3rio de dispositivos m\u00e9dicos"},"content":{"rendered":"<div>\n<h3><b data-olk-copy-source=\"MailCompose\">Iniciativa busca fortalecer a base normativa para o reprocessamento e a regulariza\u00e7\u00e3o de produtos para sa\u00fade<\/b><\/h3>\n<div>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) anunciou a abertura de uma consulta dirigida sobre a nova proposta de marco regulat\u00f3rio federal para dispositivos m\u00e9dicos. O lan\u00e7amento da iniciativa ser\u00e1 realizado em um<a href=\"https:\/\/teams.microsoft.com\/l\/meetup-join\/19%3ameeting_M2JiZmZlNGMtYTJlOS00Yjc3LThkNzEtZDVjZjM4MWJmNGFl%40thread.v2\/0?context=%7B%22Tid%22%3A%22b67af23f-c3f3-4d35-80c7-b7085f5edd81%22%2C%22Oid%22%3A%2263cbee0d-24e2-4bc7-80b6-f5b64ea6d757%22%2C%22IsBroadcastMeeting%22%3Atrue%2C%22role%22%3A%22a%22%7D&amp;btype=a&amp;role=a\"> evento virtual<\/a> no pr\u00f3ximo dia 13 de maio, \u00e0s 9h (hor\u00e1rio de Bras\u00edlia), por meio da plataforma Microsoft Teams.<\/div>\n<h3><b>Foco em dispositivos m\u00e9dicos reutiliz\u00e1veis e de uso \u00fanico<\/b><\/h3>\n<div>A consulta dirigida tem como objetivo discutir e coletar contribui\u00e7\u00f5es sobre o enquadramento e a regulariza\u00e7\u00e3o de dispositivos m\u00e9dicos reutiliz\u00e1veis e de uso \u00fanico. Al\u00e9m disso, ser\u00e3o abordadas as boas pr\u00e1ticas para o processamento desses produtos, com vistas a aprimorar a seguran\u00e7a sanit\u00e1ria e a efici\u00eancia regulat\u00f3ria no setor.<\/div>\n<h3><b>Participa\u00e7\u00e3o restrita ao SNVS<\/b><\/h3>\n<div>O evento e a consulta s\u00e3o exclusivos para os entes que comp\u00f5em o Sistema Nacional de Vigil\u00e2ncia Sanit\u00e1ria (SNVS). A participa\u00e7\u00e3o ativa dos representantes desse sistema \u00e9 considerada essencial para a constru\u00e7\u00e3o de uma regulamenta\u00e7\u00e3o mais robusta e alinhada com as realidades locais e regionais da vigil\u00e2ncia sanit\u00e1ria.<\/div>\n<h3><b>Envio de contribui\u00e7\u00f5es: de 13 de maio a 13 de junho<\/b><\/h3>\n<div>O per\u00edodo para envio de contribui\u00e7\u00f5es ser\u00e1 de 13 de maio a 13 de junho de 2025. As sugest\u00f5es recolhidas durante esse processo ir\u00e3o subsidiar a elabora\u00e7\u00e3o de minutas de quatro novas normas. Posteriormente, essas minutas ser\u00e3o submetidas \u00e0 consulta p\u00fablica, etapa em que toda a sociedade poder\u00e1 participar com opini\u00f5es e propostas.<\/div>\n<h3><b>Divulga\u00e7\u00e3o de formul\u00e1rios e pr\u00f3ximos passos<\/b><\/h3>\n<div>Os links para os formul\u00e1rios de contribui\u00e7\u00e3o ser\u00e3o disponibilizados durante o evento de lan\u00e7amento e tamb\u00e9m estar\u00e3o acess\u00edveis no portal da Anvisa. A expectativa \u00e9 que o processo colaborativo fortale\u00e7a a regulamenta\u00e7\u00e3o e amplie a transpar\u00eancia nas decis\u00f5es t\u00e9cnicas da Ag\u00eancia.<\/div>\n<h3><b>Consolida\u00e7\u00e3o normativa e fortalecimento do sistema regulat\u00f3rio<\/b><\/h3>\n<div>Com essa iniciativa, a Anvisa busca consolidar um arcabou\u00e7o regulat\u00f3rio mais robusto, baseado em evid\u00eancias, e que reflita as necessidades pr\u00e1ticas do SNVS. O objetivo \u00e9 ampliar a efic\u00e1cia da vigil\u00e2ncia sanit\u00e1ria sobre dispositivos m\u00e9dicos, promovendo maior seguran\u00e7a ao paciente e racionalidade na ado\u00e7\u00e3o de tecnologias em sa\u00fade.<\/div>\n<\/div>\n<div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>A Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria (Anvisa) anunciou a abertura de uma consulta dirigida sobre a nova proposta de marco regulat\u00f3rio federal para dispositivos m\u00e9dicos. O lan\u00e7amento da iniciativa ser\u00e1 realizado em um evento virtual no pr\u00f3ximo dia 13 de maio, \u00e0s 9h (hor\u00e1rio de Bras\u00edlia), por meio da plataforma Microsoft Teams.<\/p>\n","protected":false},"author":9,"featured_media":8283,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[84,73,67,68,53,60,69],"tags":[86,174],"class_list":["post-8281","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-anvisa","category-cannabis","category-els","category-els-group","category-geral","category-noticias","category-questoes-regulatorias","tag-anvisa","tag-dispositivos-medicos"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Anvisa promove novo marco regulat\u00f3rio de dispositivos m\u00e9dicos<\/title>\n<meta name=\"description\" content=\"A Anvisa anunciou a abertura de uma consulta dirigida sobre a nova proposta de marco regulat\u00f3rio federal para dispositivos m\u00e9dicos.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa\" \/>\n<meta property=\"og:description\" content=\"Atualizam a lista de medicamentos com exporta\u00e7\u00e3o suspensa para garantir o abastecimento de produtos cr\u00edticos.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/els-solutions.com\/pt-pt\/anvisa-marco-regulatorio-dispositivos-medicos\/\" \/>\n<meta property=\"og:site_name\" content=\"ELS Group - 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