{"id":32210,"date":"2024-03-20T10:22:13","date_gmt":"2024-03-20T09:22:13","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=32210"},"modified":"2024-03-20T10:26:46","modified_gmt":"2024-03-20T09:26:46","slug":"canada-aumento-de-las-tarifas-y-proximos-plazos-para-los-productos-sanitarios","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2024\/03\/20\/canada-aumento-de-las-tarifas-y-proximos-plazos-para-los-productos-sanitarios\/","title":{"rendered":"CANAD\u00c1: aumento de las tarifas y pr\u00f3ximos plazos para los productos sanitarios"},"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><strong>El 1 de abril de 2024 <\/strong>representa una fecha muy importante para el mercado de productos sanitarios en Canad\u00e1. En primer lugar, a partir de esta fecha entrar\u00e1n en vigor las tarifas modificadas para las solicitudes, como el registro de dispositivos, relacionadas con productos sanitarios.<\/h2>\n<p>Adem\u00e1s, los titulares de una <strong>Licencia de Establecimiento de Productos Sanitarios (MDEL)<\/strong> tendr\u00e1n que solicitar una revisi\u00f3n de su licencia cada a\u00f1o antes del 1 de abril, excluidos los titulares de una licencia con una MDEL suspendida.<\/p>\n<p><strong>Las tarifas<\/strong> sufrir\u00e1n un aumento general; por ejemplo, la solicitud de licencia para un dispositivo de la clase II pasar\u00e1 de costar 589 $ a 615 $, la de un dispositivo de la clase III de 12.987 $ a 13.559 $, la de un dispositivo de la clase IV de 28.165 $ a 29.40 $, la licencia de establecimiento para dispositivos m\u00e9dicos costar\u00e1 5.283 $ y dejar\u00e1 de costar 5.060 $.<\/p>\n<p>En cuanto a la <strong>MDEL<\/strong> (Medical Device Establishment Licence), los fabricantes deben solicitar una revisi\u00f3n de su licencia antes del 1 de abril de 2024, ya sea para solicitar una nueva licencia o para solicitar modificaciones o cancelaciones. Si un fabricante ha cesado sus actividades de comercializaci\u00f3n en Canad\u00e1 y, por tanto, desea cancelar su licencia de establecimiento, sigue estando obligado a notificarlo solicitando la cancelaci\u00f3n antes del 1 de abril de 2024. Lo que se acaba de describir para el fabricante tambi\u00e9n se aplica a un <strong>distribuidor<\/strong>.<\/p>\n<p>En conclusi\u00f3n, el marco reglamentario canadiense demuestra que evoluciona constantemente para garantizar el desarrollo de un mercado innovador y competitivo. En este sentido, los cambios propuestos pretenden reforzar la regulaci\u00f3n y supervisi\u00f3n de la agencia reguladora canadiense, mejorando su capacidad de control y evaluaci\u00f3n.<\/p>\n<p><strong>&gt;&gt;<\/strong>\u00a0A 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> y evaluaci\u00f3n previa de la documentaci\u00f3n Thema apoya los <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>registros<\/strong><\/a> con Health Canada (Licencia de Dispositivos M\u00e9dicos y Licencia de Establecimiento de Dispositivos M\u00e9dicos).<\/p>\n<p>Para el registro de productos de las clases II, III y IV, es necesario adaptar el sistema de gesti\u00f3n de la calidad a los requisitos reglamentarios canadienses y obtener el <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/qualita-e-gmp-internazionali\/\"><strong>certificado MDSAP<\/strong><\/a>. Conf\u00ede en nuestros expertos para llevar a cabo el ajuste y reciba apoyo antes, durante y despu\u00e9s de la visita de inspecci\u00f3n de la organizaci\u00f3n auditora.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/medical-devices\/fees.html\">Fees for medical devices<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32207,"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-32210","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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