{"id":34893,"date":"2025-11-25T14:44:24","date_gmt":"2025-11-25T13:44:24","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34893"},"modified":"2025-11-25T15:49:07","modified_gmt":"2025-11-25T14:49:07","slug":"health-canada-inicia-la-fase-ii-de-consulta-para-modernizar-las-licencias-de-establecimiento-mdel","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2025\/11\/25\/health-canada-inicia-la-fase-ii-de-consulta-para-modernizar-las-licencias-de-establecimiento-mdel\/","title":{"rendered":"Health Canada Inicia la Fase II de Consulta para Modernizar las Licencias de Establecimiento (MDEL)"},"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-blend:overlay;--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\"><p style=\"text-align: right;\"><strong><em>Traducido con IA<\/em><\/strong><\/p>\n<p>El 8 de noviembre de 2025, Health Canada (HC) inici\u00f3 una <a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/medical-devices-compliance-bulletin\/consultation-modernizing-mdel-framework-phase-ii.html?utm_source=chatgpt.com\"><strong>consulta p\u00fablica<\/strong><\/a> sobre la propuesta de <strong>modernizaci\u00f3n de las<\/strong> <strong>Licencias de Establecimiento de Productos Sanitarios<\/strong> (<strong><em>Medical Device Establishment Licences \u2013<\/em><\/strong><em> <strong>MDEL<\/strong><\/em><strong>),<\/strong> que autorizan la comercializaci\u00f3n de productos sanitarios.<\/p>\n<p>En previsi\u00f3n de los inminentes cambios de la <strong>Segunda Fase<\/strong> de modificaciones al <strong>Reglamento de Productos Sanitarios<\/strong> (<em>Medical Devices Regulations<\/em>) y con el fin de aumentar la <strong>previsibilidad<\/strong> y la <strong>transparencia<\/strong> para la industria, Health Canada desea recabar las opiniones de las partes interesadas (<em>stakeholders<\/em>).<\/p>\n<p>Esta iniciativa sigue a la Primera Fase de modificaciones, que culmin\u00f3 con la publicaci\u00f3n de reglamentos en la <a href=\"https:\/\/gazette.gc.ca\/rp-pr\/p2\/2024\/2024-07-03\/html\/sor-dors136-eng.html\"><em>Gaceta de Canad\u00e1, Parte II<\/em><\/a> (17 de junio de 2024), que entraron en vigor el 14 de diciembre de 2024. Adem\u00e1s, se enmarca en el <strong>Plan Regulador Prospectivo 2024-2026<\/strong> (<em>Forward Regulatory Plan 2024-2026<\/em>) de Health Canada, que define las intervenciones estrat\u00e9gicas de reforma para hacer que el sistema regulador sea m\u00e1s eficaz y simplificado.<\/p>\n<p>La consulta est\u00e1 abierta a todas las partes interesadas y permanecer\u00e1 disponible hasta el <strong>17 de enero de 2026<\/strong> (huso horario <em>Eastern Standard Time \u2013 EST<\/em>). Health Canada tendr\u00e1 en cuenta las contribuciones recogidas durante este proceso en la publicaci\u00f3n final de los documentos.<\/p>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>Objetivos<\/strong><\/h3>\n<p>La propuesta de modificaci\u00f3n se centra en tres puntos clave, indicados expl\u00edcitamente por Health Canada:<\/p>\n<ol>\n<li><strong>Eliminar la obligaci\u00f3n para los Distribuidores Extranjeros<\/strong> (<em>Foreign Distributors<\/em>) de <strong>poseer una Licencia MDEL<\/strong>, siempre que vendan sus productos sanitarios <strong>exclusivamente a trav\u00e9s de distribuidores canadienses<\/strong> (<em>Canadian distributors<\/em>) que posean una MDEL v\u00e1lida.<br \/>\nEsta modificaci\u00f3n est\u00e1 respaldada por un an\u00e1lisis de Health Canada que estima beneficios para los distribuidores extranjeros por valor de 2,3 millones de d\u00f3lares canadienses (en valor actual) en diez a\u00f1os.<\/li>\n<li><span style=\"background-color: rgba(0, 0, 0, 0);\">Aclarar la obligaci\u00f3n para los titulares de MDEL de establecer, implementar y mantener <\/span><strong style=\"background-color: rgba(0, 0, 0, 0);\">procedimientos documentados<\/strong><span style=\"background-color: rgba(0, 0, 0, 0);\"> para todas las actividades reguladas.<\/span><\/li>\n<li><strong>Trazabilidad:<\/strong> requerir a todos los solicitantes de MDEL y a los titulares de Licencia que proporcionen una <strong>lista de personas (proveedores<\/strong>) que venden productos sanitarios en Canad\u00e1, con la obligaci\u00f3n de mantenerla actualizada.<\/li>\n<\/ol>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>Documentos de Orientaci\u00f3n Sujetos a Revisi\u00f3n<\/strong><\/h3>\n<p>Health Canada tambi\u00e9n est\u00e1 solicitando opiniones sobre las revisiones de los siguientes documentos de orientaci\u00f3n y formularios, que son parte integral del sistema MDEL:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/directives-guidance-documents-policies\/guidance-medical-device-establishment-licensing-0016.html\"><strong>GUI-0016<\/strong><\/a> (Gu\u00eda sobre la Licencia de Establecimiento de Productos Sanitarios): documento que define los requisitos para obtener y mantener la MDEL.<\/li>\n<li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/information-health-product\/medical-devices\/inspects-medical-device-establishments-0064.html\"><strong>GUI-0064<\/strong><\/a> (Gu\u00eda de Inspecciones): documento sobre c\u00f3mo Health Canada inspecciona los establecimientos.<\/li>\n<li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/information-health-product\/medical-devices\/guidance-risk-classification-medical-device-observations-0079.html\"><strong>GUI-0079<\/strong><\/a> (Gu\u00eda de Clasificaci\u00f3n de Riesgo): documento sobre la clasificaci\u00f3n del riesgo para las inspecciones, lo que influye en la frecuencia de las mismas.<\/li>\n<li><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/forms\/medical-device-establishment-licence-application-form-instructions-0292.html\"><strong>FRM-0292<\/strong><\/a> (Formulario de Solicitud): Formulario de Solicitud MDEL (<em>MDEL Application Form<\/em>) e instrucciones relativas.<\/li>\n<\/ul>\n<h3 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 32; line-height: 1.25;\" data-fontsize=\"32\" data-lineheight=\"40px\"><strong>Conclusiones y Pr\u00f3ximos Pasos<\/strong><\/h3>\n<p>La segunda fase de modificaciones al Reglamento de Productos Sanitarios (MDR) sobre las Licencias de Establecimiento representa un paso significativo: por un lado, reduce las cargas regulatorias para los distribuidores extranjeros; por otro, refuerza la trazabilidad, la calidad y el cumplimiento (<em>compliance<\/em>) para los operadores que act\u00faan en el mercado canadiense.<\/p>\n<p><strong>Continuaremos siguiendo las actualizaciones de Health Canada<\/strong> en relaci\u00f3n con el resultado de esta consulta y la publicaci\u00f3n de los reglamentos finales.<\/p>\n<p>\ud83d\udc49 Estamos listos para ofrecer apoyo en todos los aspectos regulatorios de la comercializaci\u00f3n de productos sanitarios en Canad\u00e1: <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">descubra c\u00f3mo.<\/a><\/p>\n<p><strong>FUENTE: <\/strong><a href=\"https:\/\/www.canada.ca\/en\/health-canada\/services\/drugs-health-products\/compliance-enforcement\/establishment-licences\/medical-devices-compliance-bulletin\/consultation-modernizing-mdel-framework-phase-ii.html?utm_source=chatgpt.com\">Consultation on modernizing the medical device establishment licensing (MDEL) framework &#8211; Phase II &#8211; Canada.ca<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34901,"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-34893","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>Health Canada Inicia la Fase II de Consulta para Modernizar las Licencias de Establecimiento (MDEL) - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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