{"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-1750133399\">\n\n\t<div id=\"col-1192779430\" 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>TGA\u306f\u3001\u3053\u308c\u3089\u306e\u533b\u7642\u6a5f\u5668\u696d\u754c\u304c\u65b0\u305f\u306a\u898f\u5236\u3092\u9075\u5b88\u3067\u304d\u308b\u3088\u3046\u652f\u63f4\u3059\u308b\u305f\u3081\u3001\u300c\u5fc3\u81d3\u3001\u5faa\u74b0\u5668\u7cfb\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\u516c\u8868\u3057\u307e\u3057\u305f\u3002\u6539\u6b63\u5185\u5bb9\u306b\u306f\u3001\u5fc3\u81d3\u3001\u5faa\u74b0\u5668\u7cfb\u3001\u4e2d\u67a2\u795e\u7d4c\u7cfb\u306b\u76f4\u63a5\u63a5\u89e6\u3057\u3066\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3059\u3079\u3066\u306e\u5916\u79d1\u7684\u4fb5\u8972\u6027\u533b\u7642\u6a5f\u5668\u3092\u30012021\u5e7411\u670825\u65e5\u304b\u3089\u30af\u30e9\u30b9IIa\uff08\u4f4e\uff5e\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\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u6539\u6b63\u306f\u3001\u30aa\u30fc\u30b9\u30c8\u30e9\u30ea\u30a2\u533b\u7642\u6a5f\u5668\u898f\u5236\u3092\u53ef\u80fd\u306a\u9650\u308a\u6b27\u5dde\u306e\u898f\u5236\u306b\u5408\u308f\u305b\u308b\u8a08\u753b\u306b\u3064\u3044\u3066\u610f\u898b\u3092\u52df\u308b\u305f\u3081\u3001TGA\u304c\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30f3\u30b5\u30eb\u30c6\u30fc\u30b7\u30e7\u30f3\u3092\u5b9f\u65bd\u3057\u305f\u5f8c\u306b\u5b9f\u65bd\u3055\u308c\u307e\u3057\u305f\u3002<\/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 v28.1) - 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\/\" \/>\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 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