{"id":31508,"date":"2024-01-18T15:23:53","date_gmt":"2024-01-18T14:23:53","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=31508"},"modified":"2024-01-19T09:58:40","modified_gmt":"2024-01-19T08:58:40","slug":"brasil-revision-de-la-normativa-sobre-productos-de-diagnostico-in-vitro","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/01\/18\/brasil-revision-de-la-normativa-sobre-productos-de-diagnostico-in-vitro\/","title":{"rendered":"BRASIL: revisi\u00f3n de la normativa sobre productos de diagn\u00f3stico in vitro"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>En diciembre de 2023, la Agencia <strong>Nacional de Vigilancia Sanitaria<\/strong>\u00a0<strong>de Brasil<\/strong> <strong>(ANVISA<\/strong>) actualiz\u00f3 el Reglamento <a href=\"https:\/\/antigo.anvisa.gov.br\/documents\/10181\/5673188\/RDC_830_2023_.pdf\/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9\"><em>Resolu\u00e7\u00e3o Da Diretoria Colegiada &#8211; RDC N\u00ba 830, de 6 de dezembro de 2023<\/em><\/a> <em>(RDC 830\/2023)<\/em> que cubre los <strong>Productos de<\/strong> <strong>Diagn\u00f3stico In Vitro (IVD)<\/strong>, acerc\u00e1ndolo al de Dispositivos M\u00e9dicos <em>Resolu\u00e7\u00e3o<\/em> Da <em>Diretoria Colegiada<\/em> <em>&#8211; RDC N\u00ba<\/em> <em>751, de 2022 (RDC 751\/2022)<\/em> y abandonando el Reglamento anterior, <em>Resolu\u00e7\u00e3o Da Diretoria Colegiada &#8211; RDC N\u00ba 36, de 2015 (RDC 36\/2015)<\/em>.<\/h2>\n<p>El objetivo de ANVISA es consolidar la normativa que regula los productos de diagn\u00f3stico in vitro como para los productos sanitarios, adoptando las disposiciones reglamentarias que entrar\u00e1n en vigor el <strong>1 de junio de 2024<\/strong>.<\/p>\n<p>En concreto, la \u00faltima revisi\u00f3n se ajusta a la <strong>normativa que regula los productos sanitarios, RDC 751\/2022<\/strong>, en varios <strong>aspectos<\/strong>, como:<\/p>\n<ul>\n<li>procesos reguladores;<\/li>\n<li>formularios ANVISA de solicitud de notificaci\u00f3n y registro;<\/li>\n<li>revisi\u00f3n de las solicitudes;<\/li>\n<li>renovaci\u00f3n del registro y modificaciones.<\/li>\n<\/ul>\n<p>Adem\u00e1s, los documentos a presentar, salvo el etiquetado y los formularios para ANVISA, podr\u00e1n redactarse en <strong>ingl\u00e9s, espa\u00f1ol o portugu\u00e9s<\/strong>, tal y como establece el art\u00edculo 63 de la RDC 830\/2023.<\/p>\n<p>La actualizaci\u00f3n tambi\u00e9n se refer\u00eda a la <strong>clasificaci\u00f3n de los productos de diagn\u00f3stico in vitro y <\/strong>su <strong>agrupaci\u00f3n<\/strong> <strong>en<\/strong> <strong>categor\u00edas<\/strong>, adoptando como definici\u00f3n de producto de diagn\u00f3stico in vitro la que figura en el art\u00edculo 2, apartado 2, del Reglamento IVDR (UE) 2017\/746.<\/p>\n<p>La <strong>documentaci\u00f3n t\u00e9cnica<\/strong> debe organizarse de acuerdo con la tabla del Anexo II de la RDC 830\/2023, que se alinea con el documento emitido por el Foro de Reguladores: <em>IMDRF\/RPS WG\/N13 (Edition 3) FINAL:2019 &#8211; In Vitro Diagnostic Device Market Authorization Table of Contents (lVD MA ToC).<\/em><\/p>\n<p>Por \u00faltimo, la ANVISA concede m\u00e1s importancia al uso de <strong>normas t\u00e9cnicas<\/strong>, cuidadosamente definidas en el art\u00edculo 2 de la RPC 830\/2023.<\/p>\n<p>En conclusi\u00f3n, aunque el impacto en la clasificaci\u00f3n parece ser limitado, el proceso normativo de los productos de diagn\u00f3stico in vitro experimenta cambios importantes.<\/p>\n<p>ANVISA demuestra su voluntad de mantener la regulaci\u00f3n de los productos de diagn\u00f3stico in vitro en sinton\u00eda con la de otros pa\u00edses, como EE.UU. y Europa, con el fin de garantizar la mejor tecnolog\u00eda para sus usuarios y pacientes.<\/p>\n<p>&gt;&gt; A trav\u00e9s de los servicios de\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>consultor\u00eda estrat\u00e9gica-normativa<\/strong><\/a> Thema ofrece servicios de apoyo al <strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/\"><strong>registro en ANVISA<\/strong> <\/a>\u00a0para la comercializaci\u00f3n de productos sanitarios y de diagn\u00f3stico in vitro en Brasil<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/antigo.anvisa.gov.br\/documents\/10181\/5673188\/RDC_830_2023_.pdf\/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9\">RESOLU\u00c7\u00c3O DA DIRETORIA COLEGIADA &#8211; RDC N\u00ba 830, DE 6 DE DEZEMBRO DE 2023<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":31486,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-31508","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BRASIL: revisi\u00f3n de la normativa sobre productos de diagn\u00f3stico in vitro - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, 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