{"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":"guidage-du-dispositif-cardiaque-cns-tga","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/tga-heart-cns-device-guidance\/","title":{"rendered":"La TGA publie des directives reclassifiant les dispositifs m\u00e9dicaux\u2026"},"content":{"rendered":"<p>Le <a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">TGA<\/a> a publi\u00e9 un document d\u2019orientation : \u00ab Reclassification des dispositifs m\u00e9dicaux en contact direct avec le c\u0153ur, le syst\u00e8me circulatoire central et le syst\u00e8me nerveux central \u00bb pour aider les industries de ces types de dispositifs m\u00e9dicaux \u00e0 se conformer aux nouvelles r\u00e9glementations.<\/p>\n<p>Les modifications comprennent la reclassification de tous les dispositifs m\u00e9dicaux chirurgicaux invasifs destin\u00e9s \u00e0 \u00eatre utilis\u00e9s en contact direct avec le c\u0153ur, le syst\u00e8me nerveux central (SNC) ou le syst\u00e8me nerveux central (SNC) de la classe IIa (risque faible \u00e0 moyen) \u00e0 la classe III (risque \u00e9lev\u00e9), \u00e0 compter du <strong>25 novembre 2021<\/strong>.<\/p>\n<p>Ces modifications interviennent apr\u00e8s que la Therapeutic Goods Administration (TGA) a men\u00e9 une consultation publique afin de recueillir des commentaires sur ses projets visant \u00e0 aligner, lorsque cela est possible, la r\u00e9glementation australienne sur les dispositifs m\u00e9dicaux sur le cadre de l&#039;Union europ\u00e9enne.<\/p>\n<p>Si une personne est le sponsor d&#039;un dispositif m\u00e9dical utilis\u00e9 en contact direct avec le c\u0153ur, le SCC ou le SNC, elle devra alors se conformer \u00e0 la nouvelle r\u00e9glementation en fonction du statut de son produit :<\/p>\n<p>Dispositifs m\u00e9dicaux inclus dans l&#039;ARTG avant le 25 novembre 2021 - pour les dispositifs m\u00e9dicaux de classe IIa ou IIb inclus dans l&#039;ARTG avant le 25 novembre 2021, il est autoris\u00e9 que ces dispositifs soient toujours autoris\u00e9s \u00e0 \u00eatre fournis, mais pour fournir le dispositif, le fournisseur doit informer la TGA avant le 25 mai 2022 que le dispositif devra \u00eatre reclass\u00e9 et le fournisseur devra soumettre une demande pour que le dispositif soit inclus dans l&#039;ARTG en tant que dispositif m\u00e9dical de classe III avant le 1er novembre 2024.<\/p>\n<p>Demandes d&#039;inclusion d&#039;un dispositif m\u00e9dical dans l&#039;ARTG d\u00e9pos\u00e9es avant le 25 novembre 2021 - si un fournisseur a soumis une demande d&#039;inclusion dans l&#039;ARTG pour un dispositif de classe IIa avant le 25 novembre 2021, la demande sera \u00e9valu\u00e9e et le dispositif sera inclus dans l&#039;ARTG en tant que dispositif de classe IIa selon les anciennes r\u00e8gles de classification. Pour reclasser le dispositif en dispositif de classe III, le fournisseur devra en informer la TGA avant le 25 mai 2022 et dans les 2 mois suivant la date de d\u00e9but de l&#039;entr\u00e9e du dispositif dans l&#039;ARTG, et soumettre \u00e9galement une demande d&#039;inclusion du dispositif dans l&#039;ARTG en tant que dispositif de classe III avant le 1er novembre 2024. Si le fournisseur n&#039;informe pas la TGA avant le 25 mai 2022 ou dans les deux mois suivant la date de d\u00e9but de l&#039;entr\u00e9e du dispositif dans l&#039;ARTG, le dispositif ne sera plus \u00e9ligible aux dispositions transitoires et le fournisseur devra cesser de fournir le dispositif \u00e0 partir du 1er novembre 2024 et annuler l&#039;inclusion.<\/p>\n<p>Demandes d&#039;inclusion d&#039;un nouveau dispositif m\u00e9dical dans l&#039;ARTG \u00e0 compter du 25 novembre 2021 - Toute demande de nouvelle inclusion d&#039;un nouveau dispositif qui n&#039;est pas d\u00e9j\u00e0 publi\u00e9 dans l&#039;ARTG doit \u00eatre soumise \u00e0 la TGA \u00e0 compter du 25 novembre 2021 et doit \u00eatre soumise sous la forme d&#039;une demande pour un dispositif m\u00e9dical de classe III.<\/p>\n<p>Contactez RegASK pour en savoir plus sur les changements r\u00e9glementaires relatifs aux dispositifs m\u00e9dicaux. <a href=\"https:\/\/regask.com\/fr\/contact-2\/\" target=\"_blank\" rel=\"noopener\">Contactez les experts de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/fr\/contact-2\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contactez RegASK pour plus de d\u00e9tails<\/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>En savoir plus<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-231278215\">\n\n\t<div id=\"col-1910943599\" 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\/fr\/etudes-de-cas\/ressources-etudes-de-cas-dispositifs-medicaux\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lire les \u00e9tudes de cas sur le secteur des dispositifs m\u00e9dicaux<\/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 v27.3 (Yoast SEO v27.5) - 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\/fr\/guidage-du-dispositif-cardiaque-cns-tga\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\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\/fr\/guidage-du-dispositif-cardiaque-cns-tga\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta 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