{"id":32710,"date":"2024-06-21T09:59:57","date_gmt":"2024-06-21T07:59:57","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/06\/21\/brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi\/"},"modified":"2024-06-21T10:07:55","modified_gmt":"2024-06-21T08:07:55","slug":"brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/06\/21\/brasile-programma-reliance-accesso-accelerato-per-dispositivi-medici-gia-registrati-in-altri-paesi\/","title":{"rendered":"BRASIL: Programa Confianza de acceso acelerado para productos sanitarios ya registrados en otros pa\u00edses"},"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>A partir del <strong>3 de junio de 2024<\/strong>, ser\u00e1 posible colocar <strong>dispositivos m\u00e9dicos de alto riesgo<\/strong> <strong>en<\/strong> <strong>Brasil<\/strong>, apoy\u00e1ndose en las autorizaciones recibidas en otros pa\u00edses seleccionados de todo el mundo, un camino que acelera significativamente los procedimientos de registro y que s\u00f3lo puede ser acogido con entusiasmo por la industria.<\/h2>\n<p>La importante noticia ha sido formalizada por <strong>ANVISA<\/strong>, la Agencia Reguladora Brasile\u00f1a, con la <strong>Instrucci\u00f3n Normativa 290\/2024<\/strong> del 8 de abril de 2024, que define los procedimientos optimizados para el an\u00e1lisis y aprobaci\u00f3n de las solicitudes de registro de dispositivos m\u00e9dicos, los criterios que se utilizar\u00e1n en las evaluaciones realizadas por las <strong>Autoridades Reguladoras Extranjeras Equivalentes (<\/strong>conocidas como <strong>AREE)<\/strong>.<\/p>\n<p>La medida es un paso importante en el <strong>Programa de Confianza<\/strong> <strong>Reguladora<\/strong>, impulsado por la Organizaci\u00f3n Mundial de la Salud (OMS), que define como tal la <strong>Confianza Reguladora<\/strong>: \u00abun acto por el cual la autoridad reguladora nacional de una jurisdicci\u00f3n, al adoptar su propia decisi\u00f3n, tiene en cuenta la evaluaci\u00f3n realizada por otra autoridad o instituci\u00f3n de confianza o informaci\u00f3n adicional pertinente. <strong>La autoridad que adopta este enfoque sigue siendo independiente, responsable de las decisiones <\/strong>que toma y debe rendir cuentas de las mismas, aunque se base en decisiones e informaci\u00f3n de otras autoridades\u00bb.<\/p>\n<p><strong>Autoridades Reguladoras Extranjeras Equivalentes (AREE)<\/strong><\/p>\n<p>Las Autoridades Reguladoras Extranjeras Equivalentes (AREE) representan a <strong>cuatro <\/strong>de los cinco antiguos pa\u00edses fundadores del Global Harmonization Task Force (GHTF). Se trata de un grupo voluntario de representantes de las autoridades reguladoras nacionales de productos sanitarios y de la industria creado para fomentar la armonizaci\u00f3n y convergencia reglamentarias entre los distintos pa\u00edses del mundo con el fin de favorecer el despliegue de productos seguros y eficaces.<\/p>\n<p>Las AREE autorizadas son las siguientes:<\/p>\n<ul>\n<li>TGA &#8211; Registro Australiano de Productos Terap\u00e9uticos (ARTG)<\/li>\n<li>Health Canada &#8211; Licencia de productos sanitarios<\/li>\n<li>FDA de EE.UU. &#8211; Autorizaci\u00f3n 510(k), aprobaci\u00f3n previa a la comercializaci\u00f3n (PMA) o 513(f)(2) \u00abDe Novo\u00bb<\/li>\n<li>MHLW japon\u00e9s &#8211; Aprobaci\u00f3n previa a la comercializaci\u00f3n (Shonin)<\/li>\n<\/ul>\n<p><strong>\u00bfC\u00f3mo funciona la entrada optimizada de productos sanitarios en Brasil?<\/strong><\/p>\n<p>En primer lugar, cabe se\u00f1alar que la Instrucci\u00f3n Normativa 290\/2024 s\u00f3lo se aplica a <strong>los productos sanitarios de las clases<\/strong> <strong>III y IV<\/strong> <strong>y a los de diagn\u00f3stico in vitro<\/strong> que normalmente deben someterse al procedimiento de registro.<\/p>\n<p>Tales dispositivos, si ya han sido autorizados por una de las cuatro AREE, pueden ser liberados en Brasil mucho m\u00e1s r\u00e1pidamente. Debe identificarse un AREE principal y, si se han obtenido varias autorizaciones, pueden notificarse AREE adicionales.<\/p>\n<p>Deben presentarse <strong>documentos <\/strong>que prueben que los productos destinados al mercado brasile\u00f1o tienen las mismas caracter\u00edsticas de producci\u00f3n, indicaciones y uso previsto aprobados por la autoridad reguladora reconocida.<\/p>\n<p>Para solicitar una autorizaci\u00f3n de comercializaci\u00f3n, es necesario presentar:<\/p>\n<ul>\n<li>Una declaraci\u00f3n firmada por el director t\u00e9cnico y el responsable jur\u00eddico;<\/li>\n<li>Una prueba de la autorizaci\u00f3n recibida de la Autoridad Reguladora Extranjera Equivalente identificada;<\/li>\n<li>Las instrucciones de uso (IFU).<\/li>\n<\/ul>\n<p>La v\u00eda Confianza acelera la entrada en el mercado brasile\u00f1o, pero <strong>no excluye algunos pasos, <\/strong>como la presentaci\u00f3n del <strong>expediente<\/strong> <strong>t\u00e9cnico<\/strong> en la fase de solicitud y el cumplimiento de <strong>otros requisitos espec\u00edficos de registro<\/strong>, como la presentaci\u00f3n de los certificados INCQS, B-GMP, INMETRO o ANTEL.<\/p>\n<p>Se calcula que la v\u00eda Confianza reducir\u00eda los plazos de revisi\u00f3n de ANVISA en al menos un 30%, con una disminuci\u00f3n sustancial de los tiempos de espera para los registros, lo que permitir\u00eda a la poblaci\u00f3n un acceso m\u00e1s r\u00e1pido a productos sanitarios importantes para la salud p\u00fablica.<\/p>\n<p>&gt;&gt; Thema puede acompa\u00f1arle en el mercado brasile\u00f1o con los <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>servicios de consultor\u00eda estrat\u00e9gico-normativa <\/strong><\/a><strong>\u00a0<\/strong>asisti\u00e9ndole en el <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/registrazioni-internazionali-extra-ue-dispositivi-medici-dm-e-medico-diagnostici-in-vitro-ivd\/\"><strong>registro de sus dispositivos m\u00e9dicos en Brasil<\/strong><\/a> ya sea por la v\u00eda de la Confianza, o en caso de que usted nunca haya registrado sus dispositivos m\u00e9dicos en Australia, Canad\u00e1, EE.UU. o Jap\u00f3n.<\/p>\n<p><strong>Fuente<\/strong><strong>:<\/strong><br \/>\n<a href=\"https:\/\/www.in.gov.br\/web\/dou\/-\/instrucao-normativa-in-n-290-de-4-de-abril-de-2024-552512770\">INSTRU\u00c7\u00c3O NORMATIVA &#8211; IN N\u00b0 290, DE 4 DE ABRIL DE 2024 &#8211; INSTRU\u00c7\u00c3O NORMATIVA &#8211; IN N\u00b0 290, DE 4 DE ABRIL DE 2024 &#8211; DOU &#8211; Imprensa Nacional<\/a><\/p>\n<p><a href=\"https:\/\/www.gov.br\/anvisa\/pt-br\/assuntos\/noticias-anvisa\/2024\/anvisa-ira-utilizar-analises-de-autoridades-estrangeiras-para-registro-de-dispositivos-medicos\">Anvisa ir\u00e1 utilizar an\u00e1lises de autoridades estrangeiras para registro de dispositivos m\u00e9dicos \u2014 Ag\u00eancia Nacional de Vigil\u00e2ncia Sanit\u00e1ria &#8211; Anvisa (www.gov.br)<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32693,"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-32710","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: Programa Confianza de acceso acelerado para productos sanitarios ya registrados en otros pa\u00edses<\/title>\n<meta name=\"description\" content=\"Il Medical Device Coordination Group (MDCG) ha aggiornato la linea guida MDCG 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