{"id":30287,"date":"2025-09-26T11:14:04","date_gmt":"2025-09-26T04:14:04","guid":{"rendered":"https:\/\/hitek.com.vn\/?p=30287"},"modified":"2025-09-26T11:14:04","modified_gmt":"2025-09-26T04:14:04","slug":"medical-device-software-development","status":"publish","type":"post","link":"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u3068\u306a\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3078\u306e\u65b0\u898f\u53c2\u5165\u304c\u5897\u3048\u3066\u3044\u308b"},"content":{"rendered":"<p>\u304b\u3064\u3066\u533b\u7642\u6a5f\u5668\u3068\u3044\u3048\u3070\u3001\u8074\u8a3a\u5668\u3084\u624b\u8853\u5200\u3068\u3044\u3063\u305f\u7269\u7406\u7684\u306a\u5de5\u5177\u3001\u3042\u308b\u3044\u306fCT\u30b9\u30ad\u30e3\u30f3\u3084MRI\u3068\u3044\u3063\u305f\u5927\u578b\u306e\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u304c\u4e3b\u6d41\u3067\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u30c7\u30b8\u30bf\u30eb\u6280\u8853\u306e\u6ce2\u306f\u533b\u7642\u306e\u6838\u5fc3\u306b\u3082\u5230\u9054\u3057\u3001\u4eca\u3001<strong>\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3068\u3057\u3066\u306e\u533b\u7642\u6a5f\u5668<\/strong>\u3001\u3044\u308f\u3086\u308b<strong>SaMD<\/strong> \u306e\u9818\u57df\u3067\u3001\u5f93\u6765\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u306f\u7570\u306a\u308b\u65b0\u898f\u53c2\u5165\u304c\u76f8\u6b21\u3044\u3067\u3044\u307e\u3059\u3002\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306f\u3082\u3061\u308d\u3093\u3001IT\u4f01\u696d\u3084\u5927\u5b66\u767a\u30d9\u30f3\u30c1\u30e3\u30fc\u304c\u3001AI\u8a3a\u65ad\u652f\u63f4\u3084\u9060\u9694\u60a3\u8005\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3068\u3044\u3063\u305f\u753b\u671f\u7684\u306a\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\u3067\u5e02\u5834\u306b\u98a8\u7a74\u3092\u958b\u3051\u3088\u3046\u3068\u3057\u3066\u3044\u308b\u306e\u3067\u3059\u3002\u3053\u306e\u52d5\u304d\u306f\u3001\u533b\u7642\u306e\u5728\u308a\u65b9\u305d\u306e\u3082\u306e\u3092\u518d\u5b9a\u7fa9\u3059\u308b\u53ef\u80fd\u6027\u3092\u79d8\u3081\u3066\u3044\u307e\u3059\u3002<\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title ez-toc-toggle\" style=\"cursor:pointer\">Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path 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href=\"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/#%E3%81%AA%E3%81%9C%E4%BB%8A%E3%80%81%E6%96%B0%E8%A6%8F%E5%8F%82%E5%85%A5%E3%81%8C%E5%8A%A0%E9%80%9F%E3%81%99%E3%82%8B%E3%81%AE%E3%81%8B\" >\u306a\u305c\u4eca\u3001\u65b0\u898f\u53c2\u5165\u304c\u52a0\u901f\u3059\u308b\u306e\u304b<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/#%E6%96%B0%E8%A6%8F%E5%8F%82%E5%85%A5%E4%BC%81%E6%A5%AD%E3%81%8C%E7%9B%B4%E9%9D%A2%E3%81%99%E3%82%8B%E7%8F%BE%E5%AE%9F%E7%9A%84%E3%81%AA%E8%AA%B2%E9%A1%8C\" >\u65b0\u898f\u53c2\u5165\u4f01\u696d\u304c\u76f4\u9762\u3059\u308b\u73fe\u5b9f\u7684\u306a\u8ab2\u984c<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/#%E6%88%90%E5%8A%9F%E3%81%AE%E3%82%AB%E3%82%AE%E3%82%92%E6%8F%A1%E3%82%8B%E3%82%82%E3%81%AE%EF%BC%9A%E5%8D%94%E6%A5%AD%E3%81%A8%E6%88%A6%E7%95%A5\" >\u6210\u529f\u306e\u30ab\u30ae\u3092\u63e1\u308b\u3082\u306e\uff1a\u5354\u696d\u3068\u6226\u7565<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/#%E5%BE%93%E6%9D%A5%E5%9E%8B%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%83%A1%E3%83%BC%E3%82%AB%E3%83%BC%E3%81%A8SaMD%E4%BC%81%E6%A5%AD%E3%81%AE%E6%AF%94%E8%BC%83\" >\u5f93\u6765\u578b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068SaMD\u4f01\u696d\u306e\u6bd4\u8f03<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/hitek.com.vn\/ja\/blog-ja\/medical-device-software-development\/#%E6%9C%AA%E6%9D%A5%E3%81%AE%E5%8C%BB%E7%99%82%E3%82%92%E6%8F%8F%E3%81%8F%EF%BC%9ASaMD%E3%81%8C%E6%8B%93%E3%81%8F%E5%8F%AF%E8%83%BD%E6%80%A7\" >\u672a\u6765\u306e\u533b\u7642\u3092\u63cf\u304f\uff1aSaMD\u304c\u62d3\u304f\u53ef\u80fd\u6027<\/a><\/li><\/ul><\/nav><\/div>\n<h2 id=\"-samd-\"><span class=\"ez-toc-section\" id=\"%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%81%A8%E3%81%AA%E3%82%8B%E3%82%BD%E3%83%95%E3%83%88%E3%82%A6%E3%82%A7%E3%82%A2%EF%BC%88SaMD%EF%BC%89%E3%81%A8%E3%81%AF%E4%BD%95%E3%81%8B\"><\/span>\u533b\u7642\u6a5f\u5668\u3068\u306a\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08SaMD\uff09\u3068\u306f\u4f55\u304b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u307e\u305a\u3001\u305d\u306e\u5b9a\u7fa9\u3092\u660e\u78ba\u306b\u3057\u3066\u304a\u304d\u307e\u3057\u3087\u3046\u3002<strong>SaMD<\/strong> \u3068\u306f\u3001\u300cSoftware as a Medical Device\u300d\u306e\u7565\u3067\u3001\u5358\u4f53\u3067\u533b\u7642\u76ee\u7684\u3092\u9054\u6210\u3059\u308b\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u3053\u3068\u3092\u6307\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001\u75c5\u9662\u306e\u4e88\u7d04\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0\u3084\u96fb\u5b50\u30ab\u30eb\u30c6\u306f\u8a72\u5f53\u3057\u307e\u305b\u3093\u3002\u3053\u308c\u306b\u5bfe\u3057\u3001\u533b\u7642\u753b\u50cf\u304b\u3089\u75c5\u5909\u3092\u81ea\u52d5\u691c\u51fa\u3059\u308bAI\u30bd\u30d5\u30c8\u3084\u3001\u30b9\u30de\u30fc\u30c8\u30d5\u30a9\u30f3\u306e\u52a0\u901f\u5ea6\u30bb\u30f3\u30b5\u30fc\u3068\u9023\u52d5\u3057\u3066\u8ee2\u5012\u3092\u691c\u77e5\u3057\u901a\u77e5\u3059\u308b\u30a2\u30d7\u30ea\u306a\u3069\u3001\u305d\u308c\u81ea\u4f53\u304c\u8a3a\u65ad\u3001\u6cbb\u7642\u3001\u4e88\u9632\u306b\u76f4\u63a5\u5bc4\u4e0e\u3059\u308b\u3082\u306e\u304c<strong>SaMD<\/strong>\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002<\/p>\n<p>\u56fd\u969b\u533b\u7642\u6a5f\u5668\u898f\u5236\u5f53\u5c40\u30d5\u30a9\u30fc\u30e9\u30e0\u304c\u7b56\u5b9a\u3057\u305f\u3053\u306e\u5b9a\u7fa9\u306f\u3001\u65e5\u672c\u3067\u3082<strong><a href=\"https:\/\/www.mhlw.go.jp\/index.html\" target=\"_blank\" rel=\"noopener\">\u539a\u751f\u52b4\u50cd\u7701<\/a><\/strong> \u304a\u3088\u3073<strong><a href=\"https:\/\/www.pmda.go.jp\/\" target=\"_blank\" rel=\"noopener\">\u533b\u85ac\u54c1\u533b\u7642\u6a5f\u5668\u7dcf\u5408\u6a5f\u69cb\uff08PMDA\uff09<\/a><\/strong> \u306b\u3088\u3063\u3066\u63a1\u7528\u3055\u308c\u3001\u898f\u5236\u306e\u67a0\u7d44\u307f\u304c\u69cb\u7bc9\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u306b\u4f9d\u5b58\u3057\u306a\u3044\u7d14\u7c8b\u306a\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u304c\u300c\u533b\u7642\u6a5f\u5668\u300d\u3068\u3057\u3066\u627f\u8a8d\u3055\u308c\u308b\u6642\u4ee3\u304c\u3001\u78ba\u5b9f\u306b\u8a2a\u308c\u3066\u3044\u308b\u306e\u3067\u3059\u3002<\/p>\n<h2 id=\"-\"><span class=\"ez-toc-section\" id=\"%E3%81%AA%E3%81%9C%E4%BB%8A%E3%80%81%E6%96%B0%E8%A6%8F%E5%8F%82%E5%85%A5%E3%81%8C%E5%8A%A0%E9%80%9F%E3%81%99%E3%82%8B%E3%81%AE%E3%81%8B\"><\/span>\u306a\u305c\u4eca\u3001\u65b0\u898f\u53c2\u5165\u304c\u52a0\u901f\u3059\u308b\u306e\u304b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3053\u306e\u6f6e\u6d41\u3092\u5f8c\u62bc\u3057\u3059\u308b\u8981\u56e0\u306f\u8907\u6570\u3001\u91cd\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<ol>\n<li><strong>\u898f\u5236\u74b0\u5883\u306e\u660e\u78ba\u5316\u3068\u52b9\u7387\u5316<\/strong>: \u304b\u3064\u3066\u306f\u4e0d\u900f\u660e\u3060\u3063\u305fSaMD\u306e\u627f\u8a8d\u5be9\u67fb\u30d7\u30ed\u30bb\u30b9\u304c\u3001PMDA\u306b\u3088\u308a\u6bb5\u968e\u7684\u306b\u6574\u5099\u3055\u308c\u3066\u304d\u307e\u3057\u305f\u3002\u7279\u306b<strong><a href=\"https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/0003.html\" target=\"_blank\" rel=\"noopener\">AI\u30fbSaMD\u306e\u5be9\u67fb\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/a><\/strong> \u304c\u516c\u958b\u3055\u308c\u305f\u3053\u3068\u3067\u3001\u958b\u767a\u4f01\u696d\u306f\u5be9\u67fb\u306e\u8981\u4ef6\u3092\u4e8b\u524d\u306b\u628a\u63e1\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u3001\u958b\u767a\u306e\u30ea\u30b9\u30af\u304c\u8efd\u6e1b\u3055\u308c\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5236\u306e\u300c\u898b\u3048\u308b\u5316\u300d\u304c\u3001\u6280\u8853\u529b\u3092\u6301\u3064\u304c\u533b\u7642\u696d\u754c\u306e\u7d4c\u9a13\u304c\u6d45\u3044\u4f01\u696d\u306e\u53c2\u5165\u969c\u58c1\u3092\u4e0b\u3052\u3066\u3044\u307e\u3059\u3002<\/li>\n<li><strong>\u6280\u8853\u306e\u6210\u719f\u3068\u30b3\u30b9\u30c8\u4f4e\u4e0b<\/strong>: \u30c7\u30a3\u30fc\u30d7\u30e9\u30fc\u30cb\u30f3\u30b0\u3092\u306f\u3058\u3081\u3068\u3059\u308bAI\u6280\u8853\u304c\u5b9f\u7528\u30ec\u30d9\u30eb\u306b\u9054\u3057\u3001\u30af\u30e9\u30a6\u30c9\u30b3\u30f3\u30d4\u30e5\u30fc\u30c6\u30a3\u30f3\u30b0\u306e\u5229\u7528\u30b3\u30b9\u30c8\u3082\u4f4e\u4e0b\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5927\u898f\u6a21\u306a\u8a08\u7b97\u8cc7\u6e90\u3092\u5fc5\u8981\u3068\u3059\u308b\u9ad8\u5ea6\u306a\u533b\u7642\u7528\u30a2\u30eb\u30b4\u30ea\u30ba\u30e0\u306e\u958b\u767a\u304c\u3001\u5927\u4f01\u696d\u3060\u3051\u3067\u306a\u304f\u4e2d\u5c0f\u4f01\u696d\u3084\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306b\u3082\u73fe\u5b9f\u7684\u306a\u9078\u629e\u80a2\u3068\u306a\u3063\u305f\u306e\u3067\u3059\u3002<\/li>\n<li><strong>\u5e02\u5834\u306e\u5f37\u70c8\u306a\u30cb\u30fc\u30ba<\/strong>: \u5c11\u5b50\u9ad8\u9f62\u5316\u304c\u9032\u3080\u65e5\u672c\u3067\u306f\u3001\u533b\u5e2b\u4e0d\u8db3\u3084\u533b\u7642\u683c\u5dee\u662f\u6b63\u304c\u55ab\u7dca\u306e\u8ab2\u984c\u3067\u3059\u3002\u9060\u9694\u5730\u304b\u3089\u306e\u8a3a\u7642\u3092\u53ef\u80fd\u306b\u3059\u308b<strong>\u9060\u9694\u533b\u7642<\/strong>\u3084\u3001\u60a3\u8005\u306e\u72b6\u614b\u3092\u7d99\u7d9a\u7684\u306b\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3059\u308b<strong>\u30c7\u30b8\u30bf\u30eb\u7642\u6cd5\uff08DTx\uff09<\/strong> \u3078\u306e\u671f\u5f85\u306f\u5927\u304d\u304f\u3001SaMD\u306f\u3053\u308c\u3089\u306e\u8ab2\u984c\u3092\u89e3\u6c7a\u3059\u308b\u6709\u529b\u306a\u624b\u6bb5\u3068\u3057\u3066\u6ce8\u76ee\u3092\u96c6\u3081\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ol>\n<h2 id=\"-\"><span class=\"ez-toc-section\" id=\"%E6%96%B0%E8%A6%8F%E5%8F%82%E5%85%A5%E4%BC%81%E6%A5%AD%E3%81%8C%E7%9B%B4%E9%9D%A2%E3%81%99%E3%82%8B%E7%8F%BE%E5%AE%9F%E7%9A%84%E3%81%AA%E8%AA%B2%E9%A1%8C\"><\/span>\u65b0\u898f\u53c2\u5165\u4f01\u696d\u304c\u76f4\u9762\u3059\u308b\u73fe\u5b9f\u7684\u306a\u8ab2\u984c<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3057\u304b\u3057\u3001\u53c2\u5165\u304c\u5bb9\u6613\u306b\u306a\u3063\u305f\u3068\u306f\u3044\u3048\u3001\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5e02\u5834\u306b\u53d7\u3051\u5165\u308c\u3089\u308c\u308b\u307e\u3067\u306b\u306f\u3001\u3044\u304f\u3064\u3082\u306e\u9ad8\u3044\u30cf\u30fc\u30c9\u30eb\u304c\u5f85\u3061\u53d7\u3051\u3066\u3044\u307e\u3059\u3002<\/p>\n<ul>\n<li><strong>\u53b3\u683c\u306a\u54c1\u8cea\u7ba1\u7406\u4f53\u7cfb\u306e\u69cb\u7bc9<\/strong>: IT\u696d\u754c\u3067\u4e00\u822c\u7684\u306a\u30a2\u30b8\u30e3\u30a4\u30eb\u958b\u767a\u3068\u306f\u7570\u306a\u308a\u3001\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u306b\u306f<strong>ISO 13485<\/strong>\u3068\u3044\u3063\u305f\u56fd\u969b\u898f\u683c\u306b\u6e96\u62e0\u3057\u305f\u54c1\u8cea\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u69cb\u7bc9\u304c\u6c42\u3081\u3089\u308c\u307e\u3059\u3002\u30d0\u30b0\u4fee\u6b63\u3084\u6a5f\u80fd\u8ffd\u52a0\u306e\u983b\u5ea6\u304c\u3001\u4eba\u306e\u751f\u547d\u306b\u95a2\u308f\u308b\u305f\u3081\u3001\u6975\u3081\u3066\u53b3\u683c\u306a\u7ba1\u7406\u304c\u8981\u6c42\u3055\u308c\u308b\u306e\u3067\u3059\u3002<\/li>\n<li><strong>\u81e8\u5e8a\u8a55\u4fa1\u306e\u58c1<\/strong>: \u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u6709\u52b9\u6027\u3068\u5b89\u5168\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u81e8\u5e8a\u30c7\u30fc\u30bf\u306e\u53ce\u96c6\u3068\u5206\u6790\u304c\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u3053\u306e\u81e8\u5e8a\u8a66\u9a13\u306b\u306f\u591a\u984d\u306e\u8cbb\u7528\u3068\u6642\u9593\u304c\u304b\u304b\u308a\u3001\u8cc7\u91d1\u529b\u306e\u9650\u3089\u308c\u308b\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u306b\u3068\u3063\u3066\u306f\u6700\u5927\u306e\u96e3\u95a2\u3068\u306a\u308a\u5f97\u307e\u3059\u3002<\/li>\n<li><strong>\u8ca9\u58f2\u5f8c\u306e\u8cac\u4efb<\/strong>: \u627f\u8a8d\u3092\u5f97\u3066\u5e02\u5834\u306b\u51fa\u305f\u5f8c\u3082\u3001\u7d99\u7d9a\u7684\u306a\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3084\u30d0\u30fc\u30b8\u30e7\u30f3\u30a2\u30c3\u30d7\u6642\u306e\u518d\u7533\u8acb\u306a\u3069\u3001<strong>\u5e02\u8ca9\u5f8c\u30d0\u30ea\u30b2\u30fc\u30b7\u30e7\u30f3<\/strong>\u3068\u547c\u3070\u308c\u308b\u8cac\u4efb\u304c\u767a\u751f\u3057\u307e\u3059\u3002\u3053\u308c\u306f\u300c\u30ea\u30ea\u30fc\u30b9\u3057\u3066\u7d42\u308f\u308a\u300d\u306e\u4e00\u822c\u306e\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u30d3\u30b8\u30cd\u30b9\u3068\u306f\u6839\u672c\u7684\u306b\u7570\u306a\u308b\u70b9\u3067\u3059\u3002<\/li>\n<\/ul>\n<h2 id=\"-\"><span class=\"ez-toc-section\" id=\"%E6%88%90%E5%8A%9F%E3%81%AE%E3%82%AB%E3%82%AE%E3%82%92%E6%8F%A1%E3%82%8B%E3%82%82%E3%81%AE%EF%BC%9A%E5%8D%94%E6%A5%AD%E3%81%A8%E6%88%A6%E7%95%A5\"><\/span>\u6210\u529f\u306e\u30ab\u30ae\u3092\u63e1\u308b\u3082\u306e\uff1a\u5354\u696d\u3068\u6226\u7565<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u3053\u3046\u3057\u305f\u8ab2\u984c\u3092\u4e57\u308a\u8d8a\u3048\u3066\u3044\u308b\u4f01\u696d\u306b\u5171\u901a\u3059\u308b\u306e\u306f\u3001\u30aa\u30fc\u30d7\u30f3\u306a\u5354\u696d\u59ff\u52e2\u3068\u660e\u78ba\u306a\u6226\u7565\u3067\u3059\u3002<\/p>\n<ul>\n<li><strong>\u533b\u7642\u6a5f\u95a2\u3068\u306e\u9023\u643a<\/strong>: \u5358\u72ec\u3067\u306e\u958b\u767a\u306f\u56f0\u96e3\u3067\u3059\u3002\u81e8\u5e8a\u73fe\u5834\u306e\u30cb\u30fc\u30ba\u3092\u6b63\u78ba\u306b\u628a\u63e1\u3057\u3001\u6709\u52b9\u6027\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u65e9\u671f\u304b\u3089\u533b\u5e2b\u3084\u75c5\u9662\u3068\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u3092\u7d50\u3073\u3001\u5171\u540c\u7814\u7a76\u3092\u9032\u3081\u308b\u3053\u3068\u304c\u8fd1\u9053\u3068\u306a\u308a\u307e\u3059\u3002<\/li>\n<li><strong>\u898f\u5236\u5f53\u5c40\u3068\u306e\u5bfe\u8a71<\/strong>: PMDA\u306f\u3001\u958b\u767a\u306e\u65e9\u3044\u6bb5\u968e\u304b\u3089\u5be9\u67fb\u306b\u95a2\u3059\u308b\u76f8\u8ac7\u3092\u53d7\u3051\u4ed8\u3051\u308b<strong>\u4e8b\u524d\u76f8\u8ac7\u5236\u5ea6<\/strong>\u3092\u8a2d\u3051\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u5236\u5ea6\u3092\u7a4d\u6975\u7684\u306b\u5229\u7528\u3057\u3001\u5be9\u67fb\u306e\u65b9\u5411\u6027\u3092\u3059\u308a\u5408\u308f\u305b\u3066\u3044\u304f\u3053\u3068\u3067\u3001\u5f8c\u623b\u308a\u3092\u9632\u304e\u3001\u958b\u767a\u671f\u9593\u3092\u77ed\u7e2e\u3067\u304d\u307e\u3059\u3002<\/li>\n<li><strong>\u30d3\u30b8\u30cd\u30b9\u30e2\u30c7\u30eb\u306e\u78ba\u7acb<\/strong>: \u512a\u308c\u305f\u6280\u8853\u304c\u3042\u3063\u3066\u3082\u3001\u4fdd\u967a\u511f\u7528\u304c\u8a8d\u3081\u3089\u308c\u306a\u3051\u308c\u3070\u6301\u7d9a\u53ef\u80fd\u306a\u30d3\u30b8\u30cd\u30b9\u306b\u306f\u306a\u308a\u307e\u305b\u3093\u3002<strong>\u8a3a\u7642\u5831\u916c<\/strong>\u306e\u67a0\u7d44\u307f\u306b\u3069\u3046\u4f4d\u7f6e\u3065\u3051\u3089\u308c\u308b\u304b\u3001\u3042\u308b\u3044\u306f\u4f01\u696d\u306e\u798f\u5229\u539a\u751f\u306a\u3069\u4fdd\u967a\u5916\u306e\u30eb\u30fc\u30c8\u3067\u63d0\u4f9b\u3059\u308b\u304b\u306a\u3069\u3001\u53ce\u76ca\u5316\u306e\u9053\u7b4b\u3092\u65e9\u3044\u6bb5\u968e\u304b\u3089\u63cf\u3044\u3066\u304a\u304f\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002<\/li>\n<\/ul>\n<h2 id=\"-samd-\"><span class=\"ez-toc-section\" id=\"%E5%BE%93%E6%9D%A5%E5%9E%8B%E5%8C%BB%E7%99%82%E6%A9%9F%E5%99%A8%E3%83%A1%E3%83%BC%E3%82%AB%E3%83%BC%E3%81%A8SaMD%E4%BC%81%E6%A5%AD%E3%81%AE%E6%AF%94%E8%BC%83\"><\/span>\u5f93\u6765\u578b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3068SaMD\u4f01\u696d\u306e\u6bd4\u8f03<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u4ee5\u4e0b\u306e\u8868\u306f\u3001\u4e21\u8005\u306e\u7279\u5fb4\u3092\u6bd4\u8f03\u3057\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n<table>\n<thead>\n<tr>\n<th style=\"text-align: left;\">\u7279\u5fb4<\/th>\n<th style=\"text-align: left;\">\u5f93\u6765\u578b\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc<\/th>\n<th style=\"text-align: left;\">SaMD\u65b0\u898f\u53c2\u5165\u4f01\u696d<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"text-align: left;\"><strong>\u5f37\u307f<\/strong><\/td>\n<td style=\"text-align: left;\">\u533b\u7642\u696d\u754c\u3078\u306e\u6df1\u3044\u7406\u89e3\u3001\u78ba\u7acb\u3055\u308c\u305f\u8ca9\u58f2\u30c1\u30e3\u30cd\u30eb\u3001\u898f\u5236\u5bfe\u5fdc\u306e\u30ce\u30a6\u30cf\u30a6<\/td>\n<td style=\"text-align: left;\">\u6280\u8853\u306e\u30b9\u30d4\u30fc\u30c9\u3068\u67d4\u8edf\u6027\u3001\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u5fd7\u5411\u3001\u610f\u601d\u6c7a\u5b9a\u306e\u901f\u3055<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\u958b\u767a\u30a2\u30d7\u30ed\u30fc\u30c1<\/strong><\/td>\n<td style=\"text-align: left;\">\u30a6\u30a9\u30fc\u30bf\u30fc\u30d5\u30a9\u30fc\u30eb\u578b\u3001\u9577\u671f\u306e\u958b\u767a\u30b5\u30a4\u30af\u30eb<\/td>\n<td style=\"text-align: left;\">\u30a2\u30b8\u30e3\u30a4\u30eb\u578b\u3001\u77ed\u671f\u9593\u3067\u306e\u53cd\u5fa9\u6539\u826f<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\u30ea\u30b9\u30af<\/strong><\/td>\n<td style=\"text-align: left;\">\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u9045\u308c\u3001\u65e2\u5b58\u4e8b\u696d\u3078\u306e\u4f9d\u5b58<\/td>\n<td style=\"text-align: left;\">\u898f\u5236\u5bfe\u5fdc\u306e\u7d4c\u9a13\u4e0d\u8db3\u3001\u81e8\u5e8a\u8a55\u4fa1\u306e\u8ca0\u8377\u3001\u8cc7\u91d1\u8abf\u9054\u306e\u30d7\u30ec\u30c3\u30b7\u30e3\u30fc<\/td>\n<\/tr>\n<tr>\n<td style=\"text-align: left;\"><strong>\u6a5f\u4f1a<\/strong><\/td>\n<td style=\"text-align: left;\">SaMD\u3092\u65e2\u5b58\u88fd\u54c1\u306b\u7d44\u307f\u5408\u308f\u305b\u305f\u4ed8\u52a0\u4fa1\u5024\u306e\u5275\u9020<\/td>\n<td style=\"text-align: left;\">\u30cb\u30c3\u30c1\u9818\u57df\u3067\u306e\u8fc5\u901f\u306a\u5e02\u5834\u958b\u62d3\u3001\u30c7\u30fc\u30bf\u99c6\u52d5\u578b\u306e\u65b0\u30b5\u30fc\u30d3\u30b9\u5275\u51fa<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2 id=\"-samd-\"><span class=\"ez-toc-section\" id=\"%E6%9C%AA%E6%9D%A5%E3%81%AE%E5%8C%BB%E7%99%82%E3%82%92%E6%8F%8F%E3%81%8F%EF%BC%9ASaMD%E3%81%8C%E6%8B%93%E3%81%8F%E5%8F%AF%E8%83%BD%E6%80%A7\"><\/span>\u672a\u6765\u306e\u533b\u7642\u3092\u63cf\u304f\uff1aSaMD\u304c\u62d3\u304f\u53ef\u80fd\u6027<span 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