{"id":34260,"date":"2025-06-16T14:10:13","date_gmt":"2025-06-16T12:10:13","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34260"},"modified":"2025-06-17T12:20:26","modified_gmt":"2025-06-17T10:20:26","slug":"the-udi-system-for-medical-devices-in-australia-news-and-key-deadlines","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/es\/2025\/06\/16\/the-udi-system-for-medical-devices-in-australia-news-and-key-deadlines\/","title":{"rendered":"El sistema UDI para productos sanitarios en Australia: novedades y plazos clave"},"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>El 24 de marzo de 2025 marca un hito para la industria de los productos sanitarios en Australia: en esta fecha entr\u00f3 oficialmente en vigor el sistema de <strong>Identificaci\u00f3n \u00danica de Productos Sanitarios (UDI<\/strong>, por sus siglas en ingl\u00e9s), tal y como se establece en el Reglamento <em>Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025.<\/em> Con la introducci\u00f3n del UDI, Australia refuerza su marco normativo, poni\u00e9ndolo en consonancia con las normas internacionales.<br \/>\nEste cambio tendr\u00e1 sin duda una importante repercusi\u00f3n positiva en la trazabilidad, la seguridad y la gesti\u00f3n posterior a la comercializaci\u00f3n de los productos sanitarios.<\/p>\n<p>En esta primera fase, el sistema UDI para productos sanitarios en Australia es <strong>voluntario<\/strong>. En otras palabras, los patrocinadores y fabricantes ya pueden registrarse y cargar datos en la base de datos nacional, la <strong>Australian Unique Device Identification Database (AusUDID)<\/strong>, gestionada por la Therapeutic Goods Administration (TGA).<\/p>\n<p>En cambio,<strong> la introducci\u00f3n de requisitos de <\/strong>etiquetado <strong>obligatorios <\/strong>para los productos sanitarios ser\u00e1 <strong>gradual<\/strong>.\u00a0 La primera fecha l\u00edmite est\u00e1 fijada para <strong>el 1 de julio de 2026: <\/strong>a partir de esta fecha los patrocinadores y fabricantes que distribuyan la mayor\u00eda de los productos sanitarios en Australia deber\u00e1n <strong>colocar el UDI en la etiqueta del producto<\/strong> y en todos los envases pertinentes, as\u00ed como presentar los datos a AusUDID.<\/p>\n<h3>Requisitos UDI<\/h3>\n<p>La TGA modific\u00f3 los principios esenciales del<strong> anexo 1 <\/strong>de los <a href=\"https:\/\/www.legislation.gov.au\/F2002B00237\/latest\/text\"><em>Therapeutic Goods (Medical Devices) Regulations 2002<\/em><\/a> para integrar los requisitos de UDI. Al igual que en otros pa\u00edses, el sistema UDI australiano ofrece:<\/p>\n<ul>\n<li>Asignaci\u00f3n de un c\u00f3digo UDI (UDI-DI y UDI-PI) para cada producto sanitario.<\/li>\n<li>Registro de datos UDI en la base de datos AusUDID;<\/li>\n<li>Inserci\u00f3n del c\u00f3digo UDI en la etiqueta y el envase<\/li>\n<li>Marcado directo para algunos dispositivos reutilizables.<\/li>\n<\/ul>\n<p>Adem\u00e1s, se utilizar\u00e1n dos formatos complementarios:<\/p>\n<ul>\n<li><strong>HRI<\/strong> (interpretaci\u00f3n legible por el ser humano)<\/li>\n<li><strong>AIDC<\/strong> (captura autom\u00e1tica de datos)<\/li>\n<\/ul>\n<p>Gracias a este modo dual, la trazabilidad se garantiza tanto manualmente como con sistemas automatizados a lo largo de toda la cadena de suministro.<\/p>\n<h3>Aplicaci\u00f3n gradual: plazos para los productos sanitarios<\/h3>\n<p>El UDI obligatorio seguir\u00e1 un calendario escalonado basado en la clasificaci\u00f3n de riesgo del producto.<\/p>\n<\/div><div class=\"fusion-image-element \" style=\"--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"767\" height=\"217\" title=\"Tabella_ES\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/06\/Tabella_ES.png\" alt class=\"img-responsive wp-image-34275\" srcset=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/06\/Tabella_ES-200x57.png 200w, http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/06\/Tabella_ES-400x113.png 400w, http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/06\/Tabella_ES-600x170.png 600w, http:\/\/www.thema-med.com\/wp-content\/uploads\/2025\/06\/Tabella_ES.png 767w\" sizes=\"(max-width: 1024px) 100vw, (max-width: 640px) 100vw, 767px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-2\"><p>El marcado directo para los productos de la clase IIb puede estar sujeto a excepciones espec\u00edficas indicadas por la TGA.<\/p>\n<h3>Env\u00edo de datos UDI a la base de datos TGA<\/h3>\n<p>La introducci\u00f3n del sistema UDI en Australia forma parte de un proceso de armonizaci\u00f3n mundial m\u00e1s amplio en el que participan cada vez m\u00e1s pa\u00edses del sector de los productos sanitarios. El objetivo es hacer m\u00e1s eficaz y transparente todo el ciclo de vida del producto, empezando por su <strong>trazabilidad<\/strong>, elemento clave para una gesti\u00f3n responsable y segura. Al mismo tiempo, el sistema UDI contribuye a <strong>mejorar la seguridad de los pacientes<\/strong> al facilitar una intervenci\u00f3n r\u00e1pida en caso de problemas, como <strong>retiradas del mercado o alertas de seguridad<\/strong> , y apoyar <strong>un seguimiento posterior a la comercializaci\u00f3n m\u00e1s estructurado y oportuno.<\/strong><\/p>\n<p>En este contexto, es crucial que patrocinadores y fabricantes empiecen a prepararse desde el principio. Establecer un plan de cumplimiento por fases, actualizar los procedimientos internos y familiarizarse con el funcionamiento de la base de datos <strong>AusUDID<\/strong> son pasos necesarios para garantizar una transici\u00f3n fluida y el pleno cumplimiento de los requisitos normativos australianos.<\/p>\n<p>&gt;&gt;&gt; Thema ofrece un <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/registros-internacionales-fuera-de-la-ue\/\"><strong>apoyo<\/strong><\/a> completo para el registro de productos sanitarios en Australia, incluida la conformidad con UDI. Los <a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\"><strong>\u00a0consultores de Thema<\/strong><\/a> le guiar\u00e1n en cada paso del camino, garantizando una transici\u00f3n fluida y el cumplimiento de la normativa australiana.<\/p>\n<p><strong>FUENTES: <\/strong><\/p>\n<p><a href=\"https:\/\/www.medicaldevicenews.eu\/files\/tga-australia-complying-unique-device-identification-regulations-for-medical-devices-678f6f0c87a02e1851357c47.pdf\">https:\/\/www.medicaldevicenews.eu\/files\/tga-australia-complying-unique-device-identification-regulations-for-medical-devices-678f6f0c87a02e1851357c47.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.tga.gov.au\/how-we-regulate\/manufacturing\/manufacture-medical-device\/unique-device-identification-udi-hub\/udi-resources-and-technical-documents\">https:\/\/www.tga.gov.au\/how-we-regulate\/manufacturing\/manufacture-medical-device\/unique-device-identification-udi-hub\/udi-resources-and-technical-documents<\/a><\/p>\n<p><a href=\"https:\/\/www.tga.gov.au\/resources\/guidance\/complying-unique-device-identification-timeframes-medical-devices\">https:\/\/www.tga.gov.au\/resources\/guidance\/complying-unique-device-identification-timeframes-medical-devices<\/a><\/p>\n<p><em>16\/06\/2025<\/em><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34186,"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":[1879,1871,1874,1867,1872,1870,1868,1873,1875,1869,1876,1878,1880,1877],"class_list":["post-34260","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es","tag-ausudid-es","tag-clasificacion-de-dispositivos-medicos-udi","tag-conformidad-udi-australia","tag-dispositivos-medicos-australia","tag-etiquetado-udi","tag-fechas-de-caducidad-udi-australia","tag-identificacion-unica-de-dispositivos-australia","tag-marcado-directo-udi","tag-nueva-regulacion-de-dispositivos-medicos-australia","tag-regulacion-de-dispositivos-medicos-australia","tag-seguridad-de-dispositivos-medicos","tag-tga-udi-es","tag-trazabilidad-de-dispositivos-medicos-es","tag-udi-australia-es"],"acf":[],"yoast_head":"<!-- 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