{"id":32419,"date":"2024-04-17T11:12:18","date_gmt":"2024-04-17T09:12:18","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/04\/17\/brasile-estensione-a-quattro-anni-dei-b-gmp\/"},"modified":"2024-04-18T16:09:45","modified_gmt":"2024-04-18T14:09:45","slug":"brasile-estensione-a-quattro-anni-dei-b-gmp","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/04\/17\/brasile-estensione-a-quattro-anni-dei-b-gmp\/","title":{"rendered":"BRASIL: B-GMP ampliado a cuatro a\u00f1os"},"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>El 20 de marzo de 2024, la Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria <strong>(ANVISA)<\/strong> prorrog\u00f3 oficialmente la validez de los certificados de Buenas Pr\u00e1cticas de Fabricaci\u00f3n brasile\u00f1os<strong> (B-GMP)<\/strong> a <strong>cuatro a\u00f1os <\/strong>para los fabricantes que participan en el Programa de Auditor\u00eda \u00danica de Dispositivos M\u00e9dicos (MDSAP), y esta pr\u00f3rroga entr\u00f3 en vigor el <strong>1 de abril de 2024<\/strong>.<\/h2>\n<p>En concreto, ANIVSA public\u00f3 <strong>la Resoluci\u00f3n RDC 850\/2024<\/strong> por la que se modifica el art\u00edculo 8 de la RDC 497\/2021 y se ampl\u00eda oficialmente <strong>de dos a cuatro a\u00f1os <\/strong>el certificado B-GMP para los fabricantes que participan en el programa MDSAP. Naturalmente, el fabricante debe mantener su certificado MDSAP mientras dure el certificado B-GMP.<\/p>\n<p>Adem\u00e1s, un <strong>fabricante <\/strong>que haya solicitado la renovaci\u00f3n de su certificado B-GMP pero que a\u00fan no haya recibido la aprobaci\u00f3n definitiva de ANVISA antes de la entrada en vigor de la Resoluci\u00f3n 850\/2024 <strong>podr\u00e1<\/strong> seguir <strong>benefici\u00e1ndose de<\/strong> la pr\u00f3rroga de cuatro a\u00f1os B-GMP.<\/p>\n<p>La ampliaci\u00f3n de la validez de los certificados B-GMP de 2 a 4 a\u00f1os es una innovaci\u00f3n muy importante porque aumenta a\u00fan m\u00e1s las <strong>ventajas<\/strong> de la certificaci\u00f3n MDSAP y <strong>reduce<\/strong> los costes de reglamentaci\u00f3n.<\/p>\n<p>Adem\u00e1s, la ANVISA anunci\u00f3 que la RDC 830\/2023 entrar\u00e1 en vigor el <strong>1 de junio de 2024<\/strong> , por lo que pedir\u00e1 a los fabricantes que cierren las brechas entre la RDC 36\/2015 y la RDC 830\/2023.<\/p>\n<p>En concreto, el 25 de marzo de 2024, la autoridad reguladora brasile\u00f1a public\u00f3 tres documentos de orientaci\u00f3n para la RDC 830\/2023:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/centraisdeconteudo\/publicacoes\/produtos-para-a-saude\/manuais\/perguntas-respostas-rdc-830-de-2023\/view\"><em>Perguntas &amp; Respostas &#8211; RDC 830 de 2023<\/em><\/a>;<\/li>\n<li><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/centraisdeconteudo\/publicacoes\/produtos-para-a-saude\/manuais\/rdc-830-2023-nomes-tecnicos-mudanca-de-classe-de-risco\/view\"><em>RDC 830\/2023 &#8211; Nomes t\u00e9cnicos &#8211; Mudan\u00e7a de classe de risco<\/em><\/a>;<\/li>\n<li><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/centraisdeconteudo\/publicacoes\/produtos-para-a-saude\/manuais\/rdc-830-23-nomes-tecnicos-associados-a-mais-de-uma-classe-de-risco\/view\"><em>RDC 830\/2023 &#8211; Nomes t\u00e9cnicos associados a mais de uma classe de risco<\/em><\/a>.<\/li>\n<\/ul>\n<p><strong><em>Perguntas &amp; Respostas &#8211; RDC 830 de 2023<\/em><\/strong> est\u00e1 organizado en cap\u00edtulos sobre temas espec\u00edficos y presenta las respuestas de ANVISA a las preguntas planteadas sobre la RDC 830\/2023. <strong><em>RDC 830\/2023 &#8211; Nomes t\u00e9cnicos &#8211; Mudan\u00e7a de classe de risco<\/em><\/strong> describe c\u00f3mo ha cambiado la clasificaci\u00f3n de los productos. En consecuencia, los fabricantes est\u00e1n obligados a llevar a cabo revisiones de la clasificaci\u00f3n. Por \u00faltimo, <strong><em>RDC 830\/2023 &#8211; Nomes t\u00e9cnicos associados a mais de uma classe de risco<\/em><\/strong> tambi\u00e9n describe los productos para diagn\u00f3stico in vitro con m\u00e1s de una clase de riesgo.<\/p>\n<p>Por lo tanto, se anima a los fabricantes a llevar <strong>a cabo una evaluaci\u00f3n de las diferencias entre la RDC 36\/2015 y la RDC 830\/2023<\/strong>, yendo, en particular, a revisar la clasificaci\u00f3n de sus productos para diagn\u00f3stico in vitro.<\/p>\n<p>Con la <strong>ampliaci\u00f3n de las B-GMP<\/strong>, ANVISA quiere hacer m\u00e1s ventajosa la certificaci\u00f3n MDSAP, para inducir a m\u00e1s fabricantes a comercializar sus dispositivos en Brasil.<\/p>\n<p>Con la entrada en vigor de la RDC 830\/2023, ANVISA demuestra su voluntad de mantener la regulaci\u00f3n de los productos para 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 <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>registroo 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:\/\/www.in.gov.br\/en\/web\/dou\/-\/resolucao-da-diretoria-colegiada-rdc-n-850-de-20-de-marco-de-2024-549594756\">Resoluci\u00f3n RDC 850\/2024<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32374,"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-32419","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 - 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