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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\/zh\/tga-\u5fc3\u810f-cns-\u8bbe\u5907\u6307\u5bfc\/\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\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\/zh\/tga-\u5fc3\u810f-cns-\u8bbe\u5907\u6307\u5bfc\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" 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