{"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-%e5%bf%83%e8%87%93-cns-%e3%83%87%e3%83%90%e3%82%a4%e3%82%b9-%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/tga-heart-cns-device-guidance\/","title":{"rendered":"TGA \u304c\u533b\u7642\u6a5f\u5668\u306e\u518d\u5206\u985e\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u516c\u958b"},"content":{"rendered":"<p>\u306e <a href=\"https:\/\/www.tga.gov.au\/\" target=\"_blank\" rel=\"noopener\">TGA<\/a> \u306f\u3001\u3053\u308c\u3089\u306e\u7a2e\u985e\u306e\u533b\u7642\u6a5f\u5668\u306e\u696d\u754c\u304c\u65b0\u3057\u3044\u898f\u5236\u306b\u6e96\u62e0\u3067\u304d\u308b\u3088\u3046\u306b\u652f\u63f4\u3059\u308b\u305f\u3081\u306b\u3001\u300c\u5fc3\u81d3\u3001\u4e2d\u5fc3\u5faa\u74b0\u5668\u3001\u4e2d\u67a2\u795e\u7d4c\u7cfb\u306b\u76f4\u63a5\u63a5\u89e6\u3059\u308b\u533b\u7642\u6a5f\u5668\u306e\u518d\u5206\u985e\u300d\u3068\u3044\u3046\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>\u6539\u6b63\u306b\u306f\u3001\u5fc3\u81d3\u3001\u4e2d\u67a2\u795e\u7d4c\u7cfb\u3001\u307e\u305f\u306f\u4e2d\u67a2\u795e\u7d4c\u7cfb\u306b\u76f4\u63a5\u63a5\u89e6\u3057\u3066\u4f7f\u7528\u3055\u308c\u308b\u3059\u3079\u3066\u306e\u5916\u79d1\u7684\u4fb5\u8972\u6027\u533b\u7642\u6a5f\u5668\u3092\u30af\u30e9\u30b9IIa\uff08\u4f4e\u4e2d\u30ea\u30b9\u30af\uff09\u304b\u3089\u30af\u30e9\u30b9III\uff08\u9ad8\u30ea\u30b9\u30af\uff09\u306b\u518d\u5206\u985e\u3059\u308b\u3053\u3068\u304c\u542b\u307e\u308c\u3066\u304a\u308a\u3001 <strong>2021\u5e7411\u670825\u65e5<\/strong>.<\/p>\n<p>\u3053\u308c\u3089\u306e\u6539\u6b63\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u306e\u533b\u7642\u6a5f\u5668\u898f\u5236\u3092\u53ef\u80fd\u306a\u9650\u308a\u6b27\u5dde\u9023\u5408\u306e\u67a0\u7d44\u307f\u306b\u5408\u308f\u305b\u308b\u8a08\u753b\u306b\u3064\u3044\u3066\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u6c42\u3081\u308b\u305f\u3081\u306b\u3001\u533b\u85ac\u54c1\u7ba1\u7406\u5c40\uff08TGA\uff09\u304c\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u65bd\u3057\u305f\u5f8c\u306b\u884c\u308f\u308c\u307e\u3057\u305f\u3002<\/p>\n<p>\u5fc3\u81d3\u3001CCS\u3001\u307e\u305f\u306f CNS \u306b\u76f4\u63a5\u63a5\u89e6\u3057\u3066\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30dd\u30f3\u30b5\u30fc\u3067\u3042\u308b\u5834\u5408\u306f\u3001\u88fd\u54c1\u306e\u30b9\u30c6\u30fc\u30bf\u30b9\u306b\u5fdc\u3058\u3066\u65b0\u3057\u3044\u898f\u5236\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>2021 \u5e74 11 \u6708 25 \u65e5\u3088\u308a\u524d\u306b ARTG \u306b\u542b\u307e\u308c\u3066\u3044\u305f\u533b\u7642\u6a5f\u5668 - 2021 \u5e74 11 \u6708 25 \u65e5\u3088\u308a\u524d\u306b ARTG \u306b\u542b\u307e\u308c\u3066\u3044\u305f\u30af\u30e9\u30b9 IIa \u307e\u305f\u306f IIb \u306e\u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u306f\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u4f9b\u7d66\u306f\u5f15\u304d\u7d9a\u304d\u8a31\u53ef\u3055\u308c\u3066\u3044\u307e\u3059\u304c\u3001\u6a5f\u5668\u3092\u4f9b\u7d66\u3059\u308b\u306b\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f 2022 \u5e74 5 \u6708 25 \u65e5\u307e\u3067\u306b\u6a5f\u5668\u306e\u518d\u5206\u985e\u304c\u5fc5\u8981\u3067\u3042\u308b\u3053\u3068\u3092 TGA \u306b\u901a\u77e5\u3057\u30012024 \u5e74 11 \u6708 1 \u65e5\u307e\u3067\u306b\u6a5f\u5668\u3092\u30af\u30e9\u30b9 III \u533b\u7642\u6a5f\u5668\u3068\u3057\u3066 ARTG \u306b\u542b\u3081\u308b\u305f\u3081\u306e\u7533\u8acb\u66f8\u3092\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>2021 \u5e74 11 \u6708 25 \u65e5\u4ee5\u524d\u306b\u63d0\u51fa\u3055\u308c\u305f\u533b\u7642\u6a5f\u5668\u3092 ARTG \u306b\u542b\u3081\u308b\u7533\u8acb - \u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c 2021 \u5e74 11 \u6708 25 \u65e5\u4ee5\u524d\u306b\u30af\u30e9\u30b9 IIa \u6a5f\u5668\u3092 ARTG \u306b\u542b\u3081\u308b\u7533\u8acb\u3092\u63d0\u51fa\u3057\u305f\u5834\u5408\u3001\u7533\u8acb\u306f\u8a55\u4fa1\u3055\u308c\u3001\u6a5f\u5668\u306f\u53e4\u3044\u5206\u985e\u898f\u5247\u306b\u57fa\u3065\u3044\u3066\u30af\u30e9\u30b9 IIa \u6a5f\u5668\u3068\u3057\u3066 ARTG \u306b\u542b\u3081\u3089\u308c\u307e\u3059\u3002\u30c7\u30d0\u30a4\u30b9\u3092\u30af\u30e9\u30b9 III \u30c7\u30d0\u30a4\u30b9\u306b\u518d\u5206\u985e\u3059\u308b\u306b\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f 2022 \u5e74 5 \u6708 25 \u65e5\u524d\u307e\u3067\u306b\u3001\u304b\u3064\u30c7\u30d0\u30a4\u30b9\u306e ARTG \u3078\u306e\u767b\u9332\u958b\u59cb\u65e5\u304b\u3089 2 \u304b\u6708\u4ee5\u5185\u306b TGA \u306b\u901a\u77e5\u3057\u30012024 \u5e74 11 \u6708 1 \u65e5\u524d\u307e\u3067\u306b\u30c7\u30d0\u30a4\u30b9\u3092\u30af\u30e9\u30b9 III \u30c7\u30d0\u30a4\u30b9\u3068\u3057\u3066 ARTG \u306b\u542b\u3081\u308b\u305f\u3081\u306e\u7533\u8acb\u3082\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304c 2022 \u5e74 5 \u6708 25 \u65e5\u524d\u307e\u3067\u306b\u3001\u307e\u305f\u306f\u30c7\u30d0\u30a4\u30b9\u306e ARTG \u3078\u306e\u767b\u9332\u958b\u59cb\u65e5\u304b\u3089 2 \u304b\u6708\u4ee5\u5185\u306b TGA \u306b\u901a\u77e5\u3057\u306a\u3044\u5834\u5408\u3001\u30c7\u30d0\u30a4\u30b9\u306f\u79fb\u884c\u63aa\u7f6e\u306e\u5bfe\u8c61\u5916\u3068\u306a\u308a\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f 2024 \u5e74 11 \u6708 1 \u65e5\u4ee5\u964d\u30c7\u30d0\u30a4\u30b9\u306e\u4f9b\u7d66\u3092\u505c\u6b62\u3057\u3001\u767b\u9332\u3092\u53d6\u308a\u6d88\u3059\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>2021 \u5e74 11 \u6708 25 \u65e5\u4ee5\u964d\u306b ARTG \u306b\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u3092\u8ffd\u52a0\u3059\u308b\u7533\u8acb - ARTG \u306b\u307e\u3060\u516c\u958b\u3055\u308c\u3066\u3044\u306a\u3044\u65b0\u3057\u3044\u6a5f\u5668\u3092\u65b0\u305f\u306b\u8ffd\u52a0\u3059\u308b\u7533\u8acb\u306f\u30012021 \u5e74 11 \u6708 25 \u65e5\u4ee5\u964d\u306b TGA \u306b\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u3001\u30af\u30e9\u30b9 III \u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u3068\u3057\u3066\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u533b\u7642\u6a5f\u5668\u898f\u5236\u306e\u5909\u66f4\u306b\u3064\u3044\u3066\u8a73\u3057\u304f\u306f\u3001RegASK \u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002 <a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" target=\"_blank\" rel=\"noopener\">RegASK \u306e\u5c02\u9580\u5bb6\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/ja\/%e6%8e%a5%e8%a7%a6\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306fRegASK\u306b\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044<\/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>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-1970069463\">\n\n\t<div id=\"col-1109803160\" 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\/ja\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-2\/%e3%83%aa%e3%82%bd%e3%83%bc%e3%82%b9-%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3-%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3\u3092\u8aad\u3080<\/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 with the heart, CCS or CNS from Class IIa (low-medium risk) to Class III (high risk), effective from 25 November 2021. These amendments have come about after the Therapeutic Goods Administration (TGA) conducted a public consultation in order to seek feedback on their plans to align Australian Medical Devices Regulations where possible with the European&#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 v27.6 (Yoast SEO v27.6) - 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\/ja\/tga-\u5fc3\u81d3-cns-\u30c7\u30d0\u30a4\u30b9-\u30ac\u30a4\u30c0\u30f3\u30b9\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\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\/ja\/tga-\u5fc3\u81d3-cns-\u30c7\u30d0\u30a4\u30b9-\u30ac\u30a4\u30c0\u30f3\u30b9\/\" 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