{"id":3009,"date":"2021-10-26T16:35:05","date_gmt":"2021-10-26T08:35:05","guid":{"rendered":"https:\/\/regask.com\/?p=3009"},"modified":"2024-11-22T04:44:35","modified_gmt":"2024-11-21T20:44:35","slug":"guia-del-dispositivo-tga-heart-cns","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/tga-heart-cns-device-guidance\/","title":{"rendered":"TGA publica una gu\u00eda para reclasificar dispositivos m\u00e9dicos en\u2026"},"content":{"rendered":"<p>El <a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">TGA<\/a> ha publicado un documento de orientaci\u00f3n: \u201cReclasificaci\u00f3n de dispositivos m\u00e9dicos en contacto directo con el coraz\u00f3n, el sistema circulatorio central y el sistema nervioso central\u201d para ayudar a las industrias de este tipo de dispositivos m\u00e9dicos a cumplir con las nuevas regulaciones.<\/p>\n<p>Las modificaciones incluyen la reclasificaci\u00f3n de todos los dispositivos m\u00e9dicos quir\u00fargicamente invasivos destinados a ser utilizados en contacto directo con el coraz\u00f3n, el SCC o el SNC de la Clase IIa (riesgo bajo-medio) a la Clase III (riesgo alto), con vigencia a partir de <strong>25 de noviembre de 2021<\/strong>.<\/p>\n<p>Estas modificaciones se produjeron despu\u00e9s de que la Administraci\u00f3n de Productos Terap\u00e9uticos (TGA) llevara a cabo una consulta p\u00fablica para buscar comentarios sobre sus planes para alinear las Regulaciones de Dispositivos M\u00e9dicos Australianos, cuando sea posible, con el Marco de la Uni\u00f3n Europea.<\/p>\n<p>Si una persona es patrocinadora de un dispositivo m\u00e9dico que se utiliza en contacto directo con el coraz\u00f3n, el CCS o el CNS, entonces deber\u00e1 cumplir con las nuevas regulaciones dependiendo del estado de su producto:<\/p>\n<p>Dispositivos m\u00e9dicos incluidos en la ARTG antes del 25 de noviembre de 2021: para los dispositivos m\u00e9dicos de Clase IIa o IIb incluidos en la ARTG antes del 25 de noviembre de 2021, se permite que estos dispositivos a\u00fan se puedan suministrar, pero para suministrar el dispositivo, el proveedor debe notificar a la TGA antes del 25 de mayo de 2022 que el dispositivo deber\u00e1 reclasificarse y el proveedor deber\u00e1 presentar una solicitud para que el dispositivo se incluya en la ARTG como dispositivos m\u00e9dicos de Clase III antes del 1 de noviembre de 2024.<\/p>\n<p>Solicitudes para incluir un dispositivo m\u00e9dico en la ARTG presentadas antes del 25 de noviembre de 2021: si un proveedor ha presentado una solicitud de inclusi\u00f3n en la ARTG para un dispositivo de Clase IIa antes del 25 de noviembre de 2021, se evaluar\u00e1 la solicitud y el dispositivo se incluir\u00e1 en la ARTG como un dispositivo de Clase IIa seg\u00fan las antiguas reglas de clasificaci\u00f3n. Para reclasificar el dispositivo como un dispositivo de Clase III, el proveedor deber\u00e1 notificar a la TGA antes del 25 de mayo de 2022 y dentro de los 2 meses a partir de la fecha de inicio de la entrada del dispositivo en la ARTG, y tambi\u00e9n presentar una solicitud para que el dispositivo se incluya en la ARTG como un dispositivo de Clase III antes del 1 de noviembre de 2024. Si el proveedor no notifica a la TGA antes del 25 de mayo de 2022 o dentro de los dos meses a partir de la fecha de inicio de la entrada del dispositivo en la ARTG, el dispositivo ya no ser\u00e1 elegible para los acuerdos transitorios y el proveedor debe dejar de suministrar el dispositivo a partir del 1 de noviembre de 2024 y cancelar la inclusi\u00f3n.<\/p>\n<p>Solicitudes para incluir un nuevo dispositivo m\u00e9dico en el ARTG a partir del 25 de noviembre de 2021: cualquier solicitud para una nueva inclusi\u00f3n de un nuevo dispositivo que a\u00fan no est\u00e9 publicado en el ARTG debe presentarse a la TGA a partir del 25 de noviembre de 2021 y debe presentarse como una solicitud para un dispositivo m\u00e9dico de Clase III.<\/p>\n<p>Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos. <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/www.tga.gov.au\/sites\/default\/files\/reclassification-medical-devices-direct-contact-heart-central-circulatory-central-nervous-systems-august-2021.pdf\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-706326609\">\n\n\t<div id=\"col-1145876797\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>The TGA has published a Guidance document: &#8220;Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems&#8221; to assist industries of these types of medical devices to comply with new regulations. The amendments include the reclassification of all surgically invasive medical devices intended to be used in direct contact&#8230;<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[511,39],"tags":[40],"class_list":["post-3009","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-australia-regulations","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.7 (Yoast SEO v27.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Australia&#039;s TGA Updates Heart &amp; CNS Device Rules | RegASK<\/title>\n<meta name=\"description\" content=\"Australia&#039;s TGA releases new guidance on reclassifying medical devices in contact with the heart, circulatory, &amp; nervous systems.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/es\/guia-del-dispositivo-tga-heart-cns\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"TGA Publishes Guidance Reclassifying Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems\" \/>\n<meta property=\"og:description\" content=\"Australia&#039;s TGA releases new guidance on reclassifying medical devices in contact with the heart, circulatory, &amp; nervous systems.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/es\/guia-del-dispositivo-tga-heart-cns\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-10-26T08:35:05+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T20:44:35+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png\" \/>\n\t<meta property=\"og:image:width\" content=\"689\" \/>\n\t<meta property=\"og:image:height\" content=\"626\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"TGA Publishes Guidance Reclassifying Medical Devices in&hellip;\",\"datePublished\":\"2021-10-26T08:35:05+00:00\",\"dateModified\":\"2024-11-21T20:44:35+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/\"},\"wordCount\":555,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"keywords\":[\"Latest Insights\"],\"articleSection\":[\"Australia\",\"Medical Devices\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/\",\"name\":\"Australia's TGA Updates Heart & CNS Device Rules | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"datePublished\":\"2021-10-26T08:35:05+00:00\",\"dateModified\":\"2024-11-21T20:44:35+00:00\",\"description\":\"Australia's TGA releases new guidance on reclassifying medical devices in contact with the heart, circulatory, & nervous systems.\",\"inLanguage\":\"es\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es\",\"@id\":\"https:\\\/\\\/regask.com\\\/tga-heart-cns-device-guidance\\\/#primaryimage\",\"url\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"contentUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/brain-nervous-system-medical-device.png\",\"width\":689,\"height\":626,\"caption\":\"Brain Nervous System Medical Devices\"},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/regask.com\\\/#website\",\"url\":\"https:\\\/\\\/regask.com\\\/\",\"name\":\"RegASK\",\"description\":\"The Regulatory AI Operating System for High-Performing Teams\",\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/regask.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"es\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\",\"name\":\"Benoit Trouwaert\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"La TGA de Australia actualiza las normas sobre dispositivos para el coraz\u00f3n y el sistema nervioso central | RegASK","description":"La TGA de Australia publica una nueva gu\u00eda sobre la reclasificaci\u00f3n de los dispositivos m\u00e9dicos en contacto con el coraz\u00f3n, el sistema circulatorio y el sistema nervioso.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/regask.com\/es\/guia-del-dispositivo-tga-heart-cns\/","og_locale":"es_ES","og_type":"article","og_title":"TGA Publishes Guidance Reclassifying Medical Devices in Direct Contact with the Heart, Central Circulatory and Central Nervous Systems","og_description":"Australia's TGA releases new guidance on reclassifying medical devices in contact with the heart, circulatory, & nervous systems.","og_url":"https:\/\/regask.com\/es\/guia-del-dispositivo-tga-heart-cns\/","og_site_name":"RegASK","article_publisher":"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/","article_published_time":"2021-10-26T08:35:05+00:00","article_modified_time":"2024-11-21T20:44:35+00:00","og_image":[{"width":689,"height":626,"url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","type":"image\/png"}],"author":"Benoit Trouwaert","twitter_card":"summary_large_image","twitter_creator":"@ASKRegASK","twitter_site":"@ASKRegASK","twitter_misc":{"Written by":"Benoit Trouwaert","Est. reading time":"3 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/#article","isPartOf":{"@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/"},"author":{"name":"Benoit Trouwaert","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d"},"headline":"TGA Publishes Guidance Reclassifying Medical Devices in&hellip;","datePublished":"2021-10-26T08:35:05+00:00","dateModified":"2024-11-21T20:44:35+00:00","mainEntityOfPage":{"@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/"},"wordCount":555,"publisher":{"@id":"https:\/\/regask.com\/#organization"},"image":{"@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","keywords":["Latest Insights"],"articleSection":["Australia","Medical Devices"],"inLanguage":"es"},{"@type":"WebPage","@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/","url":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/","name":"La TGA de Australia actualiza las normas sobre dispositivos para el coraz\u00f3n y el sistema nervioso central | RegASK","isPartOf":{"@id":"https:\/\/regask.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/#primaryimage"},"image":{"@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/#primaryimage"},"thumbnailUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","datePublished":"2021-10-26T08:35:05+00:00","dateModified":"2024-11-21T20:44:35+00:00","description":"La TGA de Australia publica una nueva gu\u00eda sobre la reclasificaci\u00f3n de los dispositivos m\u00e9dicos en contacto con el coraz\u00f3n, el sistema circulatorio y el sistema nervioso.","inLanguage":"es","potentialAction":[{"@type":"ReadAction","target":["https:\/\/regask.com\/tga-heart-cns-device-guidance\/"]}]},{"@type":"ImageObject","inLanguage":"es","@id":"https:\/\/regask.com\/tga-heart-cns-device-guidance\/#primaryimage","url":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","contentUrl":"https:\/\/regask.com\/wp-content\/uploads\/2021\/10\/brain-nervous-system-medical-device.png","width":689,"height":626,"caption":"Brain Nervous System Medical Devices"},{"@type":"WebSite","@id":"https:\/\/regask.com\/#website","url":"https:\/\/regask.com\/","name":"RegASK","description":"El sistema operativo de IA regulatoria para equipos de alto rendimiento","publisher":{"@id":"https:\/\/regask.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/regask.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"es"},{"@type":"Person","@id":"https:\/\/regask.com\/#\/schema\/person\/c1d261e8dcf7b1c30b2c4f2c119df42d","name":"Benoit Trouwaert"}]}},"_links":{"self":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/3009","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/users\/39"}],"replies":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/comments?post=3009"}],"version-history":[{"count":0,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/posts\/3009\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media\/3003"}],"wp:attachment":[{"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/media?parent=3009"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/categories?post=3009"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/regask.com\/es\/wp-json\/wp\/v2\/tags?post=3009"}],"curies":[{"name":"Gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}