{"id":4109,"date":"2023-01-31T16:13:16","date_gmt":"2023-01-31T08:13:16","guid":{"rendered":"https:\/\/regask.com\/?p=4109"},"modified":"2024-11-22T05:16:28","modified_gmt":"2024-11-21T21:16:28","slug":"%e8%87%aa%e4%bf%a1%e3%81%a8%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9%e3%82%92%e3%82%82%e3%81%a3%e3%81%a6samd%e3%82%92%e5%b8%82%e5%a0%b4%e3%81%ab%e6%8a%95%e5%85%a5","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/bring-your-samd-to-market-with-confidence-and-compliance\/","title":{"rendered":"\u81ea\u4fe1\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u5099\u3048\u305fSaMD\u3092\u5e02\u5834\u306b\u6295\u5165"},"content":{"rendered":"<p>\u30c7\u30b8\u30bf\u30eb \u30d8\u30eb\u30b9\u306f\u3001\u533b\u7642\u306e\u63d0\u4f9b\u65b9\u6cd5\u306b\u9769\u547d\u3092\u3082\u305f\u3089\u3057\u3066\u3044\u308b\u65b0\u8208\u5206\u91ce\u3067\u3059\u3002\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u3001\u30c7\u30fc\u30bf\u3001\u5206\u6790\u3092\u7d44\u307f\u5408\u308f\u305b\u3066\u3001\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u60a3\u8005\u306e\u8ee2\u5e30\u3092\u6539\u5584\u3057\u307e\u3059\u3002\u30c7\u30b8\u30bf\u30eb \u30d8\u30eb\u30b9 \u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u306e\u30b5\u30d6\u30bb\u30af\u30bf\u30fc\u3067\u3042\u308b\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2 (SaMD) \u306f\u3001\u696d\u754c\u898f\u6a21\u3068\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u4e21\u9762\u3067\u6025\u901f\u306a\u6210\u9577\u3092\u9042\u3052\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u307e\u3059\u307e\u3059 <a href=\"https:\/\/regask.com\/ja\/samd-%e3%83%87%e3%82%b8%e3%82%bf%e3%83%ab%e8%a8%ba%e6%96%ad%e8%a3%85%e7%bd%ae%e3%82%92%e7%b1%b3%e5%9b%bd%e3%81%a8-eu-%e3%81%a7%e8%a6%8f%e5%88%b6%e3%81%99%e3%82%8b%e6%96%b9%e6%b3%95\/\">\u30b5\u30e0<\/a> \u5c0e\u5165\u304c\u9032\u3080\u306b\u3064\u308c\u3066\u3001\u3053\u306e\u5206\u91ce\u306e\u898f\u5236\u306f\u307e\u3059\u307e\u3059\u8907\u96d1\u306b\u306a\u308a\u3001\u898f\u5236\u8981\u4ef6\u304c\u5897\u3048\u3001\u56fd\u306b\u3088\u3063\u3066\u3070\u3089\u3064\u304d\u304c\u5927\u304d\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u65b0\u3057\u3044SaMD\u88fd\u54c1\u3092\u767a\u58f2\u3059\u308b\u306e\u306f\u5927\u5909\u306a\u4f5c\u696d\u3067\u3059\u3002\u30d3\u30b8\u30cd\u30b9\u306e\u6210\u529f\u306e\u9375\u306f\u898f\u5236\u9075\u5b88\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u9069\u5207\u306a <a href=\"https:\/\/regask.com\/ja\/%e3%83%93%e3%82%b8%e3%83%8d%e3%82%b9%e3%81%ab%e5%8b%9d%e5%88%a9%e3%82%92%e3%82%82%e3%81%9f%e3%82%89%e3%81%99%e8%a6%8f%e5%88%b6%e6%88%a6%e7%95%a5%e3%82%92%e6%a7%8b%e7%af%89%e3%81%99%e3%82%8b%e6%96%b9\/\" target=\"_blank\" rel=\"noopener\">\u898f\u5236\u6226\u7565<\/a> \u3053\u308c\u3089\u3092\u5c0e\u5165\u3059\u308b\u3053\u3068\u3067\u3001\u4f01\u696d\u306f\u30d3\u30b8\u30cd\u30b9\u6226\u7565\u3068\u898f\u5236\u6d3b\u52d5\u3092\u8abf\u6574\u3057\u3001\u88fd\u54c1\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u5e02\u5834\u6295\u5165\u306e\u6210\u529f\u3092\u9054\u6210\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>\u3057\u305f\u304c\u3063\u3066\u3001SaMD\u30e1\u30fc\u30ab\u30fc\u304c\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u6975\u3081\u3066\u91cd\u8981\u3067\u3059\u3002 <a href=\"https:\/\/regask.com\/ja\/when-does-your-app-become-a-medical-device\/\" target=\"_blank\" rel=\"noopener\">\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u3069\u306e\u3088\u3046\u306b\u898f\u5236\u3055\u308c\u308b\u304b<\/a> \u5f37\u529b\u304b\u3064\u52b9\u7387\u7684\u306a\u898f\u5236\u6226\u7565\u3092\u7b56\u5b9a\u3059\u308b\u305f\u3081\u3002<\/p>\n<p>RegASK \u306f\u3001\u5f37\u529b\u306a\u30c9\u30e1\u30a4\u30f3\u5c02\u9580\u77e5\u8b58\u3068 20 \u5e74\u3092\u8d85\u3048\u308b\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u7d4c\u9a13\u3092\u6d3b\u7528\u3057\u3001SaMD \u30e1\u30fc\u30ab\u30fc\u306e\u898f\u5236\u5bfe\u5fdc\u3068\u5546\u696d\u7684\u6210\u529f\u3092\u652f\u63f4\u3057\u3066\u304d\u305f\u5b9f\u7e3e\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><strong>\u88fd\u54c1\u306e\u5206\u985e\u3068\u767b\u9332\u304b\u3089\u5546\u54c1\u5316\u307e\u3067\u3001RegASK \u304c\u30c7\u30b8\u30bf\u30eb \u30d8\u30eb\u30b9\u4f01\u696d\u304c\u30a2\u30b8\u30a2\u3067\u6700\u9069\u306a\u898f\u5236\u6226\u7565\u3092\u69cb\u7bc9\u3059\u308b\u306e\u306b\u3069\u306e\u3088\u3046\u306b\u5f79\u7acb\u3063\u305f\u304b\u306b\u3064\u3044\u3066\u306f\u3001\u30b1\u30fc\u30b9 \u30b9\u30bf\u30c7\u30a3\u3092\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002<\/strong><\/p>\n<h2 class=\"h4\"><strong>\u5ba2\u89b3\u7684<\/strong><\/h2>\n<p>\u4e16\u754c\u6709\u6570\u306e\u30c7\u30b8\u30bf\u30eb\u30e1\u30f3\u30bf\u30eb\u30d8\u30eb\u30b9\u30b1\u30a2\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u304c\u3001\u3055\u307e\u3056\u307e\u306a\u969c\u5bb3\u3092\u6301\u3064\u60a3\u8005\u306b\u8a8d\u77e5\u884c\u52d5\u7642\u6cd5 (CBT) \u3092\u63d0\u4f9b\u3059\u308b\u30a2\u30d7\u30ea\u3092\u958b\u767a\u3057\u307e\u3057\u305f\u3002\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u9999\u6e2f\u3001\u30de\u30ec\u30fc\u30b7\u30a2\u3001\u30bf\u30a4\u3092\u542b\u3080\u3044\u304f\u3064\u304b\u306e\u30a2\u30b8\u30a2\u8af8\u56fd\u3067\u3053\u306e\u30a2\u30d7\u30ea\u3092\u5c55\u958b\u3057\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u81ea\u793e\u306e\u30a2\u30d7\u30ea\u3092\u5546\u54c1\u5316\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3001\u307e\u305f\u5bfe\u8c61\u5e02\u5834\u3067\u4f55\u3089\u304b\u306e\u5236\u9650\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u77e5\u308a\u305f\u3044\u3068\u8003\u3048\u3066\u3044\u307e\u3057\u305f\u3002\u305d\u306e\u76ee\u7684\u3092\u9054\u6210\u3059\u308b\u305f\u3081\u306b\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306fRegASK\u306b\u4f9d\u983c\u3057\u307e\u3057\u305f\u3002 <a href=\"https:\/\/regask.com\/ja\/our-solution\/#monitor\" target=\"_blank\" rel=\"noopener\">\u898f\u5236\u95a2\u9023\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\u30b5\u30fc\u30d3\u30b9<\/a>.<\/p>\n<h2 class=\"h4\"><strong>\u89e3\u6c7a<\/strong><\/h2>\n<ul>\n<li>\u9999\u6e2f\u3001\u30de\u30ec\u30fc\u30b7\u30a2\u3001\u30bf\u30a4\u306b\u304a\u3051\u308bSaMD\u306e\u9069\u7528\u53ef\u80fd\u306a\u898f\u5236\u67a0\u7d44\u307f\u3092\u7279\u5b9a\u3057\u307e\u3057\u305f\u3002<\/li>\n<li>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u88fd\u54c1\u306e\u767b\u9332\u304c\u5fc5\u8981\u306a\u56fd\u3068\u767b\u9332\u30d7\u30ed\u30bb\u30b9\u3092\u5b9a\u7fa9\u3057\u307e\u3059\u3002<\/li>\n<li>\u65e2\u5b58\u306e\u898f\u5236\u306b\u57fa\u3065\u3044\u3066\u88fd\u54c1\u3092\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5206\u985e\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5206\u6790\u3057\u307e\u3057\u305f\u3002<\/li>\n<li>\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u5e02\u5834\u3067\u767a\u58f2\u3057\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u304c\u5e0c\u671b\u3059\u308b\u30e2\u30c7\u30eb\u3067\u5546\u54c1\u5316\u3059\u308b\u53ef\u80fd\u6027\u3092\u8a55\u4fa1\u3057\u307e\u3057\u305f\u3002<\/li>\n<\/ul>\n<h2 class=\"h4\"><strong>\u7d50\u679c<\/strong><\/h2>\n<p>RegASK \u306e\u5c02\u9580\u77e5\u8b58\u306b\u3088\u308a\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u3001\u5bfe\u8c61\u5e02\u5834\u3067 SaMD \u88fd\u54c1\u3092\u767a\u58f2\u3059\u308b\u305f\u3081\u306e\u6700\u3082\u9069\u5207\u306a\u898f\u5236\u7d4c\u8def\u3092\u6c7a\u5b9a\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u60c5\u5831\u3092\u5165\u624b\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>RegASK \u304c\u5b9f\u65bd\u3057\u305f\u898f\u5236\u306e\u6982\u8981\u3068\u8a55\u4fa1\u306b\u3088\u308a\u3001\u30af\u30e9\u30a4\u30a2\u30f3\u30c8\u306f\u898f\u5236\u306e\u691c\u7d22\u306b\u8cbb\u3084\u3059\u4f55\u767e\u6642\u9593\u3082\u7bc0\u7d04\u3057\u3001\u6210\u529f\u306e\u53ef\u80fd\u6027\u3092\u6700\u5927\u5316\u3059\u308b\u305f\u3081\u306e\u6700\u9069\u306a\u898f\u5236\u6226\u7565\u3092\u8a2d\u8a08\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3057\u305f\u3002<\/p>\n<a data-animate=\"fadeInUp\" 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\" rel=\"noopener\" >\n\t\t<span>\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u305d\u306e\u4ed6\u306e\u4e8b\u4f8b\u3092\u8aad\u3080<\/span>\n\t<\/a>","protected":false},"excerpt":{"rendered":"<p>Digital health is an emerging field that is revolutionizing the way healthcare is delivered. It combines technology, data, and analytics to improve diagnoses, treatment, and patient outcomes. Software-as-a-Medical-Device (SaMD), as a subsector of digital health solutions, is experiencing fast growth in both industry scale and innovations. With more and more SaMD being rolled out, regulations in this field have become increasingly complex, with more regulatory requirements and greater variations across different countries. Launching a new SaMD product can be a daunting task. The key to business success is regulatory compliance. However, with the right regulatory strategy in place, companies can align their business strategy and regulatory activities to achieve product&#8230;<\/p>","protected":false},"author":39,"featured_media":4108,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[17,22,535],"tags":[],"class_list":["post-4109","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-case-study","category-medical-devices","category-thailand-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.6 (Yoast SEO v27.7) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Bringing SaMD to Market with Confidence and Compliance | RegASK<\/title>\n<meta name=\"description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\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\/\u81ea\u4fe1\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u3082\u3063\u3066samd\u3092\u5e02\u5834\u306b\u6295\u5165\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Bringing SaMD to Market with Confidence and Compliance\" \/>\n<meta property=\"og:description\" content=\"Read the case study to know how RegASK assisted a digital health company to launch their SaMD product to several markets.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u81ea\u4fe1\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u3082\u3063\u3066samd\u3092\u5e02\u5834\u306b\u6295\u5165\/\" \/>\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=\"2023-01-31T08:13:16+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-21T21:16:28+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2023\/01\/bring-your-samd-to-market-with-confidence-and-compliance.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1600\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Benoit Trouwaert\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Benoit Trouwaert\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/bring-your-samd-to-market-with-confidence-and-compliance\\\/\"},\"author\":{\"name\":\"Benoit Trouwaert\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/c1d261e8dcf7b1c30b2c4f2c119df42d\"},\"headline\":\"Bringing SaMD to Market with Confidence and 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