{"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":"tga-herz-zns-geratefuhrung","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/tga-heart-cns-device-guidance\/","title":{"rendered":"TGA ver\u00f6ffentlicht Leitfaden zur Neuklassifizierung medizinischer Ger\u00e4te in \u2026"},"content":{"rendered":"<p>Der <a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">TGA<\/a> hat ein Leitfadendokument mit dem Titel \u201eNeuklassifizierung von Medizinprodukten mit direktem Kontakt mit dem Herzen, dem zentralen Kreislauf- und Nervensystem\u201c ver\u00f6ffentlicht, um die Hersteller dieser Art von Medizinprodukten bei der Einhaltung der neuen Vorschriften zu unterst\u00fctzen.<\/p>\n<p>Zu den \u00c4nderungen geh\u00f6rt die Neueinstufung aller chirurgisch-invasiven Medizinprodukte, die f\u00fcr den direkten Kontakt mit dem Herzen, dem Zentralnervensystem oder dem ZNS vorgesehen sind, von Klasse IIa (niedriges bis mittleres Risiko) in Klasse III (hohes Risiko), g\u00fcltig ab <strong>25. November 2021<\/strong>.<\/p>\n<p>Diese \u00c4nderungen kamen zustande, nachdem die Therapeutic Goods Administration (TGA) eine \u00f6ffentliche Konsultation durchgef\u00fchrt hatte, um Feedback zu ihren Pl\u00e4nen einzuholen, die australischen Vorschriften f\u00fcr Medizinprodukte soweit wie m\u00f6glich an den Rahmen der Europ\u00e4ischen Union anzugleichen.<\/p>\n<p>Wenn eine Person Sponsor eines Medizinprodukts ist, das in direktem Kontakt mit dem Herzen, dem zentralen Nervensystem oder dem ZNS verwendet wird, muss sie je nach Produktstatus die neuen Vorschriften einhalten:<\/p>\n<p>Medizinprodukte, die vor dem 25. November 2021 in das ARTG aufgenommen wurden \u2013 Medizinprodukte der Klassen IIa oder IIb, die vor dem 25. November 2021 in das ARTG aufgenommen wurden, d\u00fcrfen weiterhin geliefert werden. Um das Ger\u00e4t liefern zu k\u00f6nnen, muss der Lieferant die TGA jedoch vor dem 25. Mai 2022 dar\u00fcber informieren, dass das Ger\u00e4t neu klassifiziert werden muss. Au\u00dferdem muss der Lieferant vor dem 1. November 2024 einen Antrag auf Aufnahme des Ger\u00e4ts in das ARTG als Medizinprodukt der Klasse III einreichen.<\/p>\n<p>Antr\u00e4ge auf Aufnahme eines Medizinprodukts in das ARTG, die vor dem 25. November 2021 eingereicht wurden \u2013 wenn ein Lieferant vor dem 25. November 2021 einen Antrag auf Aufnahme eines Produkts der Klasse IIa in das ARTG gestellt hat, wird der Antrag gepr\u00fcft und das Produkt gem\u00e4\u00df den alten Klassifizierungsregeln als Produkt der Klasse IIa in das ARTG aufgenommen. Um das Produkt in ein Produkt der Klasse III umzuklassifizieren, muss der Lieferant die TGA vor dem 25. Mai 2022 und innerhalb von 2 Monaten nach dem Beginn der Aufnahme des Ger\u00e4ts in das ARTG benachrichtigen und au\u00dferdem vor dem 1. November 2024 einen Antrag auf Aufnahme des Ger\u00e4ts in das ARTG als Produkt der Klasse III einreichen. Wenn der Lieferant die TGA nicht vor dem 25. Mai 2022 oder innerhalb von zwei Monaten nach dem Beginn der Aufnahme des Ger\u00e4ts in das ARTG benachrichtigt, f\u00e4llt das Ger\u00e4t nicht mehr unter die \u00dcbergangsregelungen und der Lieferant muss die Lieferung des Ger\u00e4ts ab dem 1. November 2024 einstellen und die Aufnahme stornieren.<\/p>\n<p>Antr\u00e4ge auf Aufnahme eines neuen Medizinprodukts in das ARTG am oder nach dem 25. November 2021 \u2013 Jeder Antrag auf Aufnahme eines neuen Ger\u00e4ts, das noch nicht im ARTG ver\u00f6ffentlicht ist, muss am oder nach dem 25. November 2021 bei der TGA eingereicht werden und muss als Antrag f\u00fcr ein Medizinprodukt der Klasse III eingereicht werden.<\/p>\n<p>Kontaktieren Sie RegASK, um mehr \u00fcber \u00c4nderungen der Vorschriften f\u00fcr Medizinprodukte zu erfahren. <a href=\"https:\/\/regask.com\/de\/kontakt\/\" target=\"_blank\" rel=\"noopener\">Nehmen Sie Kontakt mit den Experten von RegASK auf.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/de\/kontakt\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Kontaktieren Sie RegASK f\u00fcr weitere Details<\/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>Mehr lesen<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1755328042\">\n\n\t<div id=\"col-915156576\" 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\/de\/fallstudien\/ressourcen-fallstudien-medizinprodukte\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lesen Sie Fallstudien aus der Medizinger\u00e4tebranche<\/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 v28.0 (Yoast SEO v28.3) - 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\/de\/tga-herz-zns-geratefuhrung\/\" \/>\n<meta property=\"og:locale\" content=\"de_DE\" \/>\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\/de\/tga-herz-zns-geratefuhrung\/\" \/>\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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