{"id":8865,"date":"2021-03-11T13:14:25","date_gmt":"2021-03-11T13:14:25","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=8865"},"modified":"2021-03-12T09:14:05","modified_gmt":"2021-03-12T09:14:05","slug":"a-comprehensive-guide-to-medical-device-post-market-surveillance","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/","title":{"rendered":"\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">table of 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\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f2cf0d5532a\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><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 d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f2cf0d5532a\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#What_is_Post-Market_Surveillance\" title=\"\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f \">\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Post-Market_Surveillance_vs_Vigilance\" title=\"\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u8b66\u6212\u5fc3\">\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u8b66\u6212\u5fc3<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Medical_Device_Post-Market_Surveillance_Functions\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u6a5f\u80fd\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u6a5f\u80fd<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Elements_a_PMS_must_include\" title=\"PMS\u304c\u542b\u3080\u3079\u304d\u8981\u7d20\">PMS\u304c\u542b\u3080\u3079\u304d\u8981\u7d20<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Post-Market_Surveillance_Data_collection\" title=\"\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u3002\u30c7\u30fc\u30bf\u53ce\u96c6\">\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u3002\u30c7\u30fc\u30bf\u53ce\u96c6<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Trend_analysis\" title=\"\u30c8\u30ec\u30f3\u30c9\u5206\u6790\">\n\u30c8\u30ec\u30f3\u30c9\u5206\u6790<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Benefits_of_Post-Market_Surveillance\" title=\"\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u30e1\u30ea\u30c3\u30c8\">\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u30e1\u30ea\u30c3\u30c8<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/#Medical_Device_Post-Market_Surveillance_Summary_of_report_timelines\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5831\u544a\u66f8\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u6982\u8981\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5831\u544a\u66f8\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u6982\u8981<\/a><\/li><\/ul><\/nav><\/div>\n<p><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>, <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u30e1\u30c9\u30c6\u30c3\u30af\u30fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> on Kolabtree, provides a comprehensive guide to <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u533b\u7642\u6a5f\u5668<\/a> post-market surveillance (PMS), including how to implement a PMS system.\u00a0\u00a0<\/em><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u308c\u307e\u3067\u306e\u8a18\u4e8b\u3067\u306f\u3001\u30a2\u30a4\u30c7\u30a2\u3092\u30ca\u30d7\u30ad\u30f3\u306e\u88cf\u306e\u30c7\u30b6\u30a4\u30f3\u304b\u3089\u5546\u54c1\u5316\u306e\u6bb5\u968e\u306b\u307e\u3067\u6301\u3063\u3066\u3044\u304f\u3053\u3068\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u6210\u529f\u3059\u308b\u305f\u3081\u306b\u306f <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-launch-key-steps-when-taking-product-to-market\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u767a\u58f2<\/a> \u306f\u3001\u78ba\u304b\u306b\u3059\u3079\u3066\u306e\u95a2\u4fc2\u8005\u306b\u3068\u3063\u3066\u795d\u798f\u3059\u3079\u304d\u77ac\u9593\u3067\u3059\u3002\u3057\u304b\u3057\u3001\u533b\u7642\u6a5f\u5668\u304c\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u305f\u5f8c\u3082\u3001\u3042\u306a\u305f\u306e\u4ed5\u4e8b\u306f\u7d42\u308f\u308a\u3067\u306f\u306a\u304f\u3001\u533b\u7642\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u3092\u7d99\u7d9a\u3057\u3066\u78ba\u4fdd\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u767a\u58f2\u5f8c\u306e\u5b89\u5168\u6027\u3092\u78ba\u4fdd\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u4e00\u822c\u7684\u306b\u533b\u7642\u7528\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u3068\u547c\u3070\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u88fd\u54c1\u306e\u54c1\u8cea\u3068\u6027\u80fd\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3001\u5e02\u5834\u306b\u51fa\u56de\u3063\u3066\u3044\u308b\u533b\u7642\u6a5f\u5668\u306b\u7d99\u7d9a\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u63d0\u4f9b\u3057\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304cPMS\u3092\u5b9f\u65bd\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u306e\u306f\u3001\u30a2\u30e1\u30ea\u30ab\u3084EU\u306e\u898f\u5236\u6a5f\u95a2\u304b\u3089\u8981\u6c42\u3055\u308c\u3066\u3044\u308b\u304b\u3089\u3060\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u4f5c\u696d\u3092\u6b63\u3057\u304f\u884c\u3046\u3053\u3068\u3067\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u5411\u4e0a\u3001\u3088\u308a\u826f\u3044UX\u3068\u30e6\u30fc\u30b6\u30fc\u30b5\u30fc\u30d3\u30b9\u306e\u63d0\u4f9b\u3001\u6a5f\u5668\u306e\u30d0\u30fc\u30b8\u30e7\u30f32.0\u3078\u306e\u5b66\u7fd2\u306e\u6d3b\u7528\u3001\u305d\u3057\u3066\u6700\u3082\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u6709\u5bb3\u4e8b\u8c61\u306e\u30ea\u30b9\u30af\u3092\u767a\u751f\u524d\u306b\u6700\u5c0f\u9650\u306b\u6291\u3048\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306e\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001PMS\u30b7\u30b9\u30c6\u30e0\u3092\u5c0e\u5165\u3059\u308b\u969b\u306e\u6ce8\u610f\u70b9\u3092\u4e2d\u5fc3\u306b\u3054\u7d39\u4ecb\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">PMS\u306f\u3001\u6a5f\u80fd\u7684\u306a\u8b66\u544a\u3084\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u901a\u3058\u3066\u3001\u4e8b\u8c61\u304b\u3089\u751f\u3058\u308b\u30a8\u30af\u30b9\u30dd\u30fc\u30b8\u30e3\u30fc\u3092\u6291\u5236\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u3053\u306e\u8a18\u4e8b\u306e\u76ee\u7684\u306f\u3001\u898f\u5236\u4e0a\u306e\u5c02\u9580\u7528\u8a9e\u3084\u7fa9\u52d9\u3092\u7c21\u7d20\u5316\u3057\u3001\u7c73\u56fd\u3068EU\u9593\u306e\u8981\u4ef6\u306e\u9055\u3044\u3092\u7406\u89e3\u3057\u3066\u3044\u305f\u3060\u304f\u3053\u3068\u306b\u3042\u308a\u307e\u3059\u3002\u3053\u306e\u8a18\u4e8b\u306e\u30cf\u30a4\u30e9\u30a4\u30c8\u306f<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u3068\u306f <\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9\u3068\u306e\u9055\u3044\u306f\uff1f<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u8981\u7d20\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u30b7\u30b9\u30c6\u30e0\u306e\u6a5f\u80fd\u6027<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u3068\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u3068\u30c8\u30ec\u30f3\u30c9\u5206\u6790\u306e\u305f\u3081\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u306e\u5b9f\u65bd\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u30b7\u30b9\u30c6\u30e0\u306e\u5c0e\u5165\u306b\u3088\u308b\u5168\u4f53\u7684\u306a\u30e1\u30ea\u30c3\u30c8\u00a0<\/span><\/li>\n<li aria-level=\"1\">\u30ec\u30dd\u30fc\u30c8\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"What_is_Post-Market_Surveillance\"><\/span><strong>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u306f\u4f55\u3067\u3059\u304b\uff1f <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u6307\u4ee4\u3001AIMDD\u3001IVDD\u3067\u306f\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u4e2d\u3067PMS\u3092\u6b63\u5f0f\u306b\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u305b\u3093\u3067\u3057\u305f\u304c\u3001\u533b\u7642\u6a5f\u5668\u898f\u5247\u304a\u3088\u3073\u4f53\u5916\u8a3a\u65ad\u898f\u5247\uff08IVDR\uff09\u306b\u3088\u308b\u3068\u3001PMS\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u3001\u5e02\u5834\u306b\u6295\u5165\u307e\u305f\u306f\u30b5\u30fc\u30d3\u30b9\u3092\u958b\u59cb\u3057\u305f\u533b\u7642\u6a5f\u5668\u304b\u3089\u5f97\u3089\u308c\u305f\u7d4c\u9a13\u3092\u7a4d\u6975\u7684\u306b\u53ce\u96c6\u30fb\u691c\u8a0e\u3057\u3001\u5fc5\u8981\u306a\u662f\u6b63\u63aa\u7f6e\u307e\u305f\u306f\u4e88\u9632\u63aa\u7f6e\u3092\u76f4\u3061\u306b\u9069\u7528\u3059\u308b\u5fc5\u8981\u6027\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u4f53\u7cfb\u7684\u306a\u624b\u9806\u3092\u78ba\u7acb\u3057\u3001\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u5b9f\u65bd\u3059\u308b\u3059\u3079\u3066\u306e\u6d3b\u52d5\u3092\u4fdd\u8a3c\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3067\u3059[1]\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4e00\u65b9\u3001\u7c73\u56fd\u306ePMS\u306f\u3001510(k)\u3084PMA\u306e\u627f\u8a8d\u30fb\u63d0\u51fa\u306e\u969b\u306b\u3001FDA\u306b\u3088\u308b\u975e\u5e38\u306b\u660e\u78ba\u306a\u898f\u5236\u8981\u4ef6\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002PMS\u306b\u3088\u308a\u3001\u7c73\u56fdFDA\u306f\u3001510(k)\u30af\u30ea\u30a2\u30e9\u30f3\u30b9\u3084PMA\u627f\u8a8d\u3092\u53d7\u3051\u305f\u9ad8\u30ea\u30b9\u30af\u306e\u533b\u7642\u6a5f\u5668\uff08\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u306b\u3088\u308b\uff09\u306b\u3064\u3044\u3066\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u8a66\u9a13\u306e\u5b9f\u65bd\u3092\u6c42\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u6700\u8fd1\u3001FDA\u306fPMS\u3068\u76ee\u7684\u304c\u91cd\u306a\u308b\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\u3092\u5c0e\u5165\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u3068\u30ec\u30d3\u30e5\u30fc\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306f\u3001TPLC\uff08Total Product Life Cycle\uff09\u304a\u3088\u3073IDEAL\uff08Idea Development, Exploration, Assessment, and Long-term Study\uff09\u3068\u547c\u3070\u308c\u308b\u3082\u306e\u3067\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">PMS\u306f2\u3064\u306e\u30bb\u30b0\u30e1\u30f3\u30c8\u306b\u5927\u5225\u3055\u308c\u307e\u3059\u3002 <\/span><b>\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6<\/b> <b>\u30bb\u30b0\u30e1\u30f3\u30c8<\/b><span style=\"font-weight: 400;\">:\u3053\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u3067\u306f\u3001PMS\u306f\u9867\u5ba2\u8abf\u67fb\u3084\u5e02\u8ca9\u5f8c\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\uff08MEDDEV 2.12\/2, rev 2\uff09\u7814\u7a76\u3092\u7528\u3044\u3066\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306b\u5b9f\u65bd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <\/span><b>\u30ea\u30a2\u30af\u30c6\u30a3\u30d6\u30bb\u30b0\u30e1\u30f3\u30c8<\/b><span style=\"font-weight: 400;\">PMS\u6d3b\u52d5\uff08NB-MED 2.12 rec1\uff09\u306f\u3001\u8b66\u6212\uff08MEDDEV 2.12\/1 rev 8\uff09\u3001\u4e0d\u9069\u5408\u54c1\u5831\u544a\uff08NCMR\uff09\u307e\u305f\u306f\u4fee\u6b63\u51e6\u7f6e\u8981\u6c42\uff08CAR\uff09\u306a\u3069\u306e\u53cd\u5fdc\u7684\u306b\u5b9f\u884c\u3055\u308c\u307e\u3059\u3002<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6PMS\u30a2\u30af\u30b7\u30e7\u30f3<\/b><\/td>\n<td><b>\u30ea\u30a2\u30af\u30c6\u30a3\u30d6PMS\u30a2\u30af\u30b7\u30e7\u30f3<\/b><\/td>\n<\/tr>\n<tr>\n<td>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304a\u5ba2\u69d8\u30a2\u30f3\u30b1\u30fc\u30c8<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMCF\u3092\u542b\u3080\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u8a66\u9a13\uff08\u4e3b\u306b\u30dd\u30b9\u30c8CE\u30de\u30fc\u30af\uff09\u306b\u3064\u3044\u3066<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30e1\u30fc\u30ab\u30fc\u304c\u4e3b\u50ac\u3059\u308b\u533b\u7642\u6a5f\u5668\u306e\u30c8\u30e9\u30c3\u30ad\u30f3\u30b0\/\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8\u30fb\u30ec\u30b8\u30b9\u30c8\u30ea<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30d5\u30a9\u30fc\u30ab\u30b9\u30b0\u30eb\u30fc\u30d7\uff08\u30a8\u30ad\u30b9\u30d1\u30fc\u30c8\u30e6\u30fc\u30b6\u30fc\u30b0\u30eb\u30fc\u30d7\u3001\u30af\u30ec\u30fc\u30e0\u524d\u306e\u30bd\u30fc\u30b7\u30e3\u30eb\u30e1\u30c7\u30a3\u30a2\u30ad\u30e3\u30f3\u30da\u30fc\u30f3\u306b\u3088\u308b\u30b0\u30eb\u30fc\u30d7\u8abf\u67fb\u306a\u3069\u3092\u542b\u3080<\/span><\/li>\n<\/ol>\n<\/td>\n<td>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30e6\u30fc\u30b6\u30fc\/\u304a\u5ba2\u69d8\u304b\u3089\u306e\u82e6\u60c5<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u672a\u627f\u8afe\u306e\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\uff08\u53d7\u52d5\u7684\u307e\u305f\u306f\u5426\u5b9a\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306a\u3069\uff09\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30b5\u30fc\u30d3\u30b9\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u793e\u5185\u3067\u306e\u30c6\u30b9\u30c8\uff08\u3053\u308c\u306f\u65e5\u5e38\u7684\u306a\u54c1\u8cea\u30c1\u30a7\u30c3\u30af\u3068\u3057\u3066\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u6545\u969c\u30fb\u5f71\u97ff\u89e3\u6790<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30bd\u30fc\u30b7\u30e3\u30eb\u30e1\u30c7\u30a3\u30a2\u3078\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30ec\u30b8\u30b9\u30c8\u30ea\u30fc\uff08\u5730\u57df\u307e\u305f\u306f\u56fd\u3001\u30e1\u30fc\u30ab\u30fc\u4ee5\u5916\u306e\u30b9\u30dd\u30f3\u30b5\u30fc\u306b\u3088\u308b\u8a66\u9a13<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u6587\u732e\u8abf\u67fb<\/span><\/li>\n<\/ol>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Post-Market_Surveillance_vs_Vigilance\"><\/span><strong>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3068\u8b66\u6212\u5fc3<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u3001PMS\u3068\u30d3\u30b8\u30e9\u30f3\u30b9\u3092\u4ea4\u4e92\u306b\u4f7f\u7528\u3057\u3066\u3044\u308b\u5834\u5408\u3082\u3042\u308a\u307e\u3059\u304c\u3001\u5927\u5c40\u7684\u306b\u898b\u308b\u3068\u3001PMS\u3068\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u7bc4\u56f2\u306f\u305d\u308c\u305e\u308c\u7570\u306a\u3063\u3066\u304a\u308a\u3001\u30d3\u30b8\u30e9\u30f3\u30b9\u306fPMS\u306e\u30ea\u30a2\u30af\u30c6\u30a3\u30d6\u30ab\u30c6\u30b4\u30ea\u30fc\u306e\u4e00\u5074\u9762\u306b\u904e\u304e\u307e\u305b\u3093\u3002\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9\u306f\u3001\u533b\u7642\u6a5f\u5668\u3084\u4f53\u5916\u8a3a\u65ad\u7528\u6a5f\u5668\u304c\u610f\u56f3\u3057\u305f\u901a\u308a\u306e\u6027\u80fd\u3092\u767a\u63ee\u3067\u304d\u306a\u304b\u3063\u305f\u5834\u5408\u306b\u767a\u751f\u3059\u308b\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3001FSCA\uff08Field-Safety Corrective Action\uff09\u3001\u30ea\u30b3\u30fc\u30eb\u306a\u3069\u306b\u5bfe\u5fdc\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u3053\u308c\u306b\u306f\u3001\u610f\u56f3\u3057\u305f\u3068\u304a\u308a\u306b\u52d5\u4f5c\u3057\u306a\u304b\u3063\u305f\u3053\u3068\u3067\u3001\u6700\u60aa\u306e\u5834\u5408\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306e\u8ca0\u50b7\u3084\u6b7b\u4ea1\u306b\u3064\u306a\u304c\u308b\u30b7\u30ca\u30ea\u30aa\u3082\u542b\u307e\u308c\u307e\u3059\u3002\u30bf\u30a4\u30e0\u30ea\u30fc\u3067\u5354\u8abf\u7684\u306a\u884c\u52d5\u3092\u3068\u308b\u3053\u3068\u304c\u898f\u5236\u6a5f\u95a2\u304b\u3089\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u304a\u308a\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3001\u73fe\u5834\u3067\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u662f\u6b63\u63aa\u7f6e\u3001\u30ea\u30b3\u30fc\u30eb\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30d3\u30b8\u30e9\u30f3\u30b9\u306e\u552f\u4e00\u306e\u76ee\u7684\u306f\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306e\u5065\u5eb7\u3068\u5b89\u5168\u3092\u5b88\u308a\u3001\u6f5c\u5728\u7684\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u306e\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3057\u3001\u305d\u306e\u518d\u767a\u3092\u9632\u6b62\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9\u306f\u307e\u305f\u3001\u662f\u6b63\u63aa\u7f6e\u3084\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u306e\u6709\u52b9\u6027\u3092\u8a55\u4fa1\u3057\u3001\u904e\u53bb\u306e\u7d4c\u9a13\u304b\u3089\u5b66\u3076\u305f\u3081\u306bCAPA\u3092\u76e3\u8996\u3059\u308b\u3053\u3068\u3082\u3067\u304d\u307e\u3059\u3002\u4e00\u65b9\u3001PMS\u306f\u3001\u30d3\u30b8\u30e9\u30f3\u30b9\u3092\u306f\u3058\u3081\u3068\u3059\u308b\u30ea\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u6d3b\u52d5\u306b\u52a0\u3048\u3001\u30ea\u30b9\u30af\u3092\u8efd\u6e1b\u3059\u308b\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u6d3b\u52d5\u3092\u542b\u3080\u4e00\u9023\u306e\u6d3b\u52d5\u3067\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Medical_Device_Post-Market_Surveillance_Functions\"><\/span>\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u6a5f\u80fd<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u767a\u58f2\uff0f\u5546\u696d\u5316\u304c\u6210\u529f\u3057\u3066\u5e02\u5834\u306b\u51fa\u305f\u5f8c\u306f\u3001PMS\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u3063\u3066\u3001\u305d\u306e\u6a5f\u5668\u3084\u95a2\u9023\u3059\u308b\u7af6\u5408\u4ed6\u793e\u306e\u6a5f\u5668\u306b\u95a2\u3059\u308b\u3059\u3079\u3066\u306e\u60c5\u5831\u3092\u53ce\u96c6\u3057\u3001\u30ec\u30d3\u30e5\u30fc\u3057\u3001\u8a55\u4fa1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u306f\u305a\u3067\u3059\u3002Notified Bodies Medical Devices (NB-MED 2.12 rec 1 - PMS)\u306b\u3088\u308b\u3068\u3001PMS\u306f\u4ee5\u4e0b\u306e\u6a5f\u80fd\u3092\u679c\u305f\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u30b7\u30b9\u30c6\u30e0\u3068\u3057\u3066\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u88fd\u9020\u4e0a\u306e\u554f\u984c\u3092\u691c\u51fa\u3059\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u5411\u4e0a\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u5206\u6790\u691c\u8a3c\u306e\u5b9f\u65bd<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u6027\u80fd\u3001\u6162\u6027\u7684\u306a\u5408\u4f75\u75c7\u3001\u6027\u80fd\u306e\u50be\u5411\u3001\u7570\u306a\u308b\u30e6\u30fc\u30b6\u30fc\u96c6\u56e3\u306b\u304a\u3051\u308b\u6027\u80fd\u306e\u9577\u671f\u7684\u306a\u60c5\u5831\u3092\u5f97\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30c7\u30d0\u30a4\u30b9\u304c\u60aa\u7528\u3055\u308c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u30e1\u30ab\u30cb\u30ba\u30e0\u306e\u691c\u51fa\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u4f7f\u7528\u4e0a\u306e\u6ce8\u610f\u3001\u4f7f\u7528\u65b9\u6cd5\u3001\u4f7f\u7528\u8005\u306b\u5fc5\u8981\u306a\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u3001\u9867\u5ba2\u6e80\u8db3\u5ea6\u3001\u5e02\u5834\u3067\u306e\u5b9f\u7e3e\u3068\u6301\u7d9a\u6027\u306b\u95a2\u3059\u308b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u63d0\u4f9b\u3059\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\u306e\u78ba\u8a8d\uff08FACA\u3092\u542b\u3080\uff09\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">PMS\u6587\u66f8\u306f\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u304c\u5e02\u5834\u306b\u6295\u5165\u3055\u308c\u305f\u969b\u306e\u6a5f\u5668\u306e\u6027\u80fd\u3092\u628a\u63e1\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u3001\u307e\u305f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u9ad8\u6c34\u6e96\u306e\u88fd\u54c1\u54c1\u8cea\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306e\u7d99\u7d9a\u7684\u306a\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u30eb\u30fc\u30d7\u3092\u69cb\u7bc9\u3057\u307e\u3059\u3002\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001PMS\u306f\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306b\u4e8b\u6545\u306e\u767a\u751f\u3001\u88fd\u54c1\u306e\u30ea\u30b3\u30fc\u30eb\u3001\u6f5c\u5728\u7684\u306a\u6545\u969c\u3092\u4e88\u544a\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u30a8\u30f3\u30b8\u30cb\u30a2\u30ea\u30f3\u30b0\u30c1\u30fc\u30e0\u3068\u88fd\u9020\u30c1\u30fc\u30e0\u304c\u9023\u643a\u3057\u3066\u8a2d\u8a08\u79fb\u7ba1\u3068PMS\u3092\u884c\u3046\u3053\u3068\u3067\u3001\u6700\u9069\u306a\u6750\u6599\u3092\u898b\u3064\u3051\u3001\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u3092\u5186\u6ed1\u306b\u9032\u3081\u308b\u305f\u3081\u306e\u5f62\u72b6\u3084\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7\u306b\u3064\u3044\u3066\u306e\u77e5\u898b\u3092\u5171\u6709\u3057\u3001\u4e00\u822c\u7684\u306a\u88fd\u9020\u7528\u8a2d\u8a08\u306e\u63d0\u6848\u306b\u3064\u3044\u3066\u8b70\u8ad6\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u898f\u5236\u4e0a\u306e\u76ee\u7684\u3067\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30c8\u30e9\u30f3\u30b9\u30d5\u30a1\u30fc\u6d3b\u52d5\u306e\u4e3b\u306a\u76ee\u7684\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u30de\u30b9\u30bf\u30fc\u30ec\u30b3\u30fc\u30c9\u3092\u5b8c\u6210\u3055\u305b\u308b\u3053\u3068\u3067\u3059\u3002\u4e00\u8a00\u3067\u8a00\u3048\u3070\u3001i<strong>\u30c7\u30b6\u30a4\u30f3\u30ec\u30d3\u30e5\u30fc\u30d7\u30ed\u30bb\u30b9\u306e\u65e9\u3044\u6bb5\u968e\u3067\u30c7\u30b6\u30a4\u30f3\u30c8\u30e9\u30f3\u30b9\u30d5\u30a1\u30fc\u306e\u69cb\u7bc9\u3092\u59cb\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308c\u3070\u3001\u5b9f\u969b\u306e\u30c7\u30b6\u30a4\u30f3\u30c8\u30e9\u30f3\u30b9\u30d5\u30a1\u30fc\u30df\u30fc\u30c6\u30a3\u30f3\u30b0\u306f\u3001\u30c7\u30b6\u30a4\u30f3\u30a2\u30a6\u30c8\u30d7\u30c3\u30c8\u306e\u627f\u8a8d\u306e\u305f\u3081\u306e\u5f62\u5f0f\u7684\u306a\u3082\u306e\u306b\u306a\u308a\u307e\u3059\u3002<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306b\u3064\u3044\u3066\u306f\u3001\u4ee5\u524d\u306b\u3082\u533b\u7642\u6a5f\u5668\u30b7\u30ea\u30fc\u30ba\u3067\u53d6\u308a\u4e0a\u3052\u307e\u3057\u305f\u304c\u3001PMS\u306e\u5c0e\u5165\u3082\u52b9\u679c\u7684\u306a\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u304b\u3089\u59cb\u307e\u308b\u3053\u3068\u3092\u5fd8\u308c\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002\u4ee5\u524d\u306e\u8a18\u4e8b\u3067\u53d6\u308a\u4e0a\u3052\u305fISO14971\u306b\u57fa\u3065\u304f\u30ea\u30b9\u30af\u5206\u6790\u3068\u30ea\u30b9\u30af\u8a55\u4fa1\u57fa\u6e96\u3092\u7528\u3044\u305f\u30ea\u30b9\u30af\u3068\u30cf\u30b6\u30fc\u30c9\u306e\u8a55\u4fa1\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002\u307e\u305f\u3001PMS\u304b\u3089\u53d6\u308a\u51fa\u3055\u308c\u305f\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u306f\u3001\u30ea\u30b9\u30af\u8efd\u6e1b\u7b56\u306b\u3088\u3063\u3066\u30ea\u30b9\u30af\u30fb\u30cf\u30b6\u30fc\u30c9\u6bd4\u304c\u6e1b\u5c11\u3057\u3001\u65b0\u305f\u306a\u30ea\u30b9\u30af\u306e\u767a\u751f\u306b\u3064\u306a\u304c\u3063\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u518d\u8a55\u4fa1\u3059\u308b\u5fc5\u8981\u304c\u3042\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u3044\u3066\u304f\u3060\u3055\u3044\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Elements_a_PMS_must_include\"><\/span>PMS\u304c\u542b\u3080\u3079\u304d\u8981\u7d20<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u6307\u4ee4\uff0893\/42\/EEC\uff09\u306b\u57fa\u3065\u304d\u3001PMS\u6587\u66f8\u306f\u4ee5\u4e0b\u306e\u4e8b\u9805\u306b\u5bfe\u5fdc\u3057\u3001\u542b\u307e\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u00a0<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u6587\u66f8\u306e\u539f\u672c\u306b\u5909\u66f4\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u306e\u5224\u65ad\u3002\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u304a\u5ba2\u69d8\u304b\u3089\u306e\u30af\u30ec\u30fc\u30e0\u306b\u9650\u3089\u305a\u3001\u5341\u5206\u306b\u5e83\u3044\u7bc4\u56f2\u3067\u691c\u8a3c\u30fb\u8a55\u4fa1\u3092\u884c\u3046\u305f\u3081\u306e\u65b9\u6cd5\u8ad6\u7684\u30fb\u4f53\u7cfb\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u306e\u3053\u3068\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u5ba2\u89b3\u7684\u306a\u8a3c\u62e0\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d5\u30a1\u30a4\u30eb\u306b\u542b\u307e\u308c\u308b\u3079\u304d\u3067\u3042\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u65b0\u3057\u3044\u30cf\u30b6\u30fc\u30c9\u306f\u3059\u3079\u3066\u8a55\u4fa1\u3057\u3001\u5f53\u521d\u306e\u30ea\u30b9\u30af\u306e\u5b9a\u7fa9\u3068\u6bd4\u8f03\u3057\u3066\u3001\u30ea\u30b9\u30af\u306e\u8a31\u5bb9\u7bc4\u56f2\u306b\u5909\u5316\u304c\u3042\u3063\u305f\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u8a55\u4fa1\/\u7ba1\u7406\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3084\u4fee\u6b63\u304c\u3042\u308c\u3070\u3001\u305d\u308c\u3082\u542b\u3081\u3066\u4fee\u6b63\u3059\u308b\u3053\u3068\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u306f\u3001\u533b\u7642\u6a5f\u5668\u304c\u5e02\u5834\u306b\u51fa\u56de\u308b\u3068\u3001\u6587\u732e\u8abf\u67fb\u3001PMCF\u3001\u9867\u5ba2\u306e\u82e6\u60c5\u3001\u8abf\u67fb\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u3042\u3089\u3086\u308b\u3053\u3068\u304cPMS\u306e\u4e00\u90e8\u306b\u306a\u308b\u3053\u3068\u3092\u899a\u3048\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u307e\u305f\u3001PMS\u306e\u30ea\u30b9\u30c8\u306b\u306f\u3001\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30e6\u30fc\u30b6\u30fc\u30b0\u30eb\u30fc\u30d7\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u53cd\u5fdc\u3001\u533b\u7642\u6a5f\u5668\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u5f97\u3089\u308c\u305f\u56de\u7b54\u3001\u3042\u3089\u3086\u308b\u7a2e\u985e\u306e\u30e1\u30c7\u30a3\u30a2\u3001\u5c55\u793a\u4f1a\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\/\u30b5\u30fc\u30d3\u30b9\u30ec\u30dd\u30fc\u30c8\u3001\u73fe\u5834\u3067\u306e\u8a55\u4fa1\u3001\u4e0b\u53d6\u308a\u3001\u793e\u5185\u3067\u306e\u30c6\u30b9\u30c8\u3001\u6545\u969c\u5206\u6790\u306a\u3069\u304c\u542b\u307e\u308c\u307e\u3059\u3002\u91cd\u8981\u306a\u3053\u3068\u306f\u3001\u3053\u3053\u3067\u306fPMS\u30c7\u30fc\u30bf\u306e\u5b8c\u5168\u306a\u30ea\u30b9\u30c8\u3092\u63b2\u8f09\u3057\u3066\u304a\u3089\u305a\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u306b\u9069\u3057\u3066\u3044\u308b\u3068\u8003\u3048\u3089\u308c\u308b\u3059\u3079\u3066\u306e\u60c5\u5831\u6e90\u3092\u63b2\u8f09\u3057\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u306a\u3044\u3068\u3044\u3046\u3053\u3068\u3067\u3042\u308b\u3002\u305d\u306e\u305f\u3081\u3001\u533b\u7642\u6a5f\u5668\u306b\u5408\u308f\u305b\u305f\u30ea\u30b9\u30c8\u3092\u5165\u624b\u3059\u308b\u306b\u306f\u3001\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u3084PMS\u306e\u5c02\u9580\u5bb6\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u3092\u304a\u52e7\u3081\u3057\u307e\u3059\u3002\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Post-Market_Surveillance_Data_collection\"><\/span>\u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u3002\u30c7\u30fc\u30bf\u53ce\u96c6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">PMS\u7528\u306e\u30c7\u30fc\u30bf\u306f\u3069\u306e\u3088\u3046\u306b\u53ce\u96c6\u3059\u308b\u306e\u3067\u3059\u304b\uff1f\u305d\u308c\u306b\u306f\u3001\u304a\u5ba2\u69d8\u304b\u3089\u306e\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u3092\u53ce\u96c6\u3059\u308b\u305f\u3081\u306e\u3059\u3079\u3066\u306e\u624b\u9806\u304c\u6574\u3063\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002PMS\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u624b\u9806\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u9867\u5ba2\u306e\u82e6\u60c5\u3084\u61f8\u5ff5\u3001\u4e0d\u9069\u5408\u6750\u6599\u3084\u88fd\u54c1\u3092\u7ba1\u7406\u3059\u308b\u305f\u3081\u306e\u624b\u9806\u3001CAPA\u3001PMS\u3001\u30b5\u30fc\u30d3\u30b9\uff08\u5fc5\u8981\u306b\u5fdc\u3058\u3066\uff09\u3001\u307e\u305f\u306f\u9867\u5ba2\u8abf\u67fb\u3067\u69cb\u6210\u3055\u308c\u307e\u3059\u3002PMS\u3067\u306f\u3001\u9069\u5207\u306a\u6587\u66f8\u5316\u304c\u975e\u5e38\u306b\u91cd\u8981\u3067\u3042\u308a\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u306b\u76f4\u63a5\u307e\u305f\u306f\u9593\u63a5\u7684\u306b\u95a2\u4e0e\u3059\u308b\u7d44\u7e54\u5185\u306e\u8a72\u5f53\u3059\u308b\u3059\u3079\u3066\u306e\u90e8\u7f72\u3084\u62c5\u5f53\u8005\u304c\u9069\u5207\u306a\u6587\u66f8\u5316\u306e\u6163\u884c\u306b\u5f93\u3044\u3001\u3059\u3079\u3066\u306e\u60c5\u5831\u304c\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">MDR\u3067\u306f\u3001\u6b21\u306e\u3088\u3046\u306aPMS\u306e\u65b0\u3057\u3044\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<table>\n<tbody>\n<tr>\n<td><b>\u30b7\u30b9\u30c6\u30e0<\/b><\/td>\n<td><b>EU MDR<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u5e02\u8ca9\u5f8c\u8abf\u67fb<\/span><\/td>\n<td><b>Article 83:<\/b><span style=\"font-weight: 400;\"> \u30e1\u30fc\u30ab\u30fc\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u4f53\u5236<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8<\/span><\/td>\n<td><b>\u4ed8\u5c5e\u66f8I,3(e)<\/b><span style=\"font-weight: 400;\"> \u30ea\u30b9\u30af\u7ba1\u7406\u4f53\u5236<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u306e\u8a08\u753b\u3068\u5831\u544a<\/span><\/td>\n<td><b>\u9644\u5c5e\u66f8XIV<\/b><span style=\"font-weight: 400;\"> \u81e8\u5e8a\u8a55\u4fa1\u3068\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u7d4c\u904e\u89b3\u5bdf<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u88fd\u9020\u8ca9\u58f2\u5f8c\u8abf\u67fb\u306e\u8a08\u753b\u3068\u5831\u544a<\/span><\/td>\n<td><b>\u9644\u5c5e\u66f8 III:<\/b><span style=\"font-weight: 400;\"> \u5e02\u8ca9\u5f8c\u306e\u76e3\u8996\u306b\u95a2\u3059\u308b\u6280\u8853\u6587\u66f8<\/span><\/p>\n<p><b>Article 84:<\/b><span style=\"font-weight: 400;\"> \u5e02\u8ca9\u5f8c\u8abf\u67fb\u8a08\u753b<\/span><\/p>\n<p><b>Article 85:<\/b><span style=\"font-weight: 400;\"> \u5e02\u8ca9\u5f8c\u8abf\u67fb\u5831\u544a\u66f8\uff08\u30af\u30e9\u30b9I<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9<\/span><\/td>\n<td><b>\u7b2c87\u6761<\/b><span style=\"font-weight: 400;\"> \u91cd\u5927\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3068\u73fe\u5834\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u662f\u6b63\u63aa\u7f6e\u306e\u5831\u544a<\/span><\/p>\n<p><b>Article 88:<\/b><span style=\"font-weight: 400;\"> \u30c8\u30ec\u30f3\u30c9\u30ec\u30dd\u30fc\u30c8<\/span><\/p>\n<p><b>Article 89:<\/b><span style=\"font-weight: 400;\"> \u91cd\u5927\u306a\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3068\u73fe\u5834\u306e\u5b89\u5168\u6027\u306b\u95a2\u3059\u308b\u662f\u6b63\u63aa\u7f6e\u306e\u5206\u6790<\/span><\/p>\n<p><b>Article 90:<\/b><span style=\"font-weight: 400;\"> \u91d1\u525b\u529b\u58eb\u30c7\u30fc\u30bf\u306e\u5206\u6790<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">PMCF\u8a08\u753b\u3068\u8a55\u4fa1\u30ec\u30dd\u30fc\u30c8<\/span><\/td>\n<td><b>\u9644\u5c5e\u66f8XIV<\/b><span style=\"font-weight: 400;\"> \u81e8\u5e8a\u8a55\u4fa1\u3068\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u7d4c\u904e\u89b3\u5bdf<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u5b9a\u671f\u7684\u306a\u5b89\u5168\u6027\u306e\u5831\u544a<\/span><\/td>\n<td><b>Article 86: <\/b><span style=\"font-weight: 400;\">\u5b9a\u671f\u7684\u306a\u5b89\u5168\u6027\u306e\u66f4\u65b0\u5831\u544a\uff08\u30af\u30e9\u30b9IIa\u3001IIb\u3001III<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u306e\u6982\u8981<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9(SSCP)<\/span><\/td>\n<td><b>Article 32:<\/b><span style=\"font-weight: 400;\"> \u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6210\u7e3e\u306e\u6982\u8981<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><span class=\"ez-toc-section\" id=\"Trend_analysis\"><\/span><strong><br \/>\n\u30c8\u30ec\u30f3\u30c9\u5206\u6790<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u30c7\u30fc\u30bf\u3092\u53ce\u96c6\u3057\u305f\u3089\u3001\u6b21\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u30a2\u30a4\u30c6\u30e0\u306f\u3001\u53ce\u96c6\u3057\u305f\u60c5\u5831\u3092\u898b\u76f4\u3057\u3001\u5206\u6790\u3057\u3001\u50be\u5411\u5206\u6790\u3092\u884c\u3046\u3053\u3068\u3067\u3059\u3002\u3082\u3046\u304a\u6c17\u3065\u304d\u306e\u3088\u3046\u306b\u3001PMS \u306f\u4e00\u5ea6\u9650\u308a\u306e\u3082\u306e\u3067\u306f\u306a\u304f\u3001\u30c7\u30fc\u30bf\u306e\u30ec\u30d3\u30e5\u30fc\u3068\u50be\u5411\u5206\u6790\u306f\u5b9a\u671f\u7684\u306b\u3001\u56db\u534a\u671f\u3054\u3068\u3067\u306a\u304f\u3066\u3082\u5c11\u306a\u304f\u3068\u3082\u5e74\u306b\u4e00\u5ea6\u306f\u5fc5\u8981\u3067\u3059\u3002FDA \u3068 ISO 13485 \u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u7533\u8acb\u8005\u306b\u5bfe\u3057\u3066\u3001\u6b63\u5f0f\u306a\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30ec\u30d3\u30e5\u30fc\u4f1a\u8b70\u306e\u4e00\u90e8 \u3068\u3057\u3066\u3001\u5e74\u6b21 PMS \u30ec\u30d3\u30e5\u30fc\u3092\u884c\u3046\u3053\u3068\u3092\u8981\u6c42\u3057\u3066\u3044\u308b\u3002\u3057\u304b\u3057\u3001\u533b\u7642\u6a5f\u5668\u306e\u65b0\u8208\u4f01\u696d\u306e\u5834\u5408\u3001\u88fd\u54c1\u3092\u3088\u308a\u826f\u304f\u3059\u308b\u305f\u3081\u306b\u3001\u307e\u305f\u771f\u306b\u52b9\u679c\u7684\u306a\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u78ba\u7acb\u3059\u308b\u305f\u3081\u306b\u3001\u6708\u6b21\u307e\u305f\u306f\u5c11\u306a\u304f\u3068\u3082\u56db\u534a\u671f\u3054\u3068\u306a\u3069\u3001\u3088\u308a\u983b\u7e41\u306b PMS \u3092\u5b9f\u65bd\u3059\u308b\u3088\u3046\u306b\u52a9\u8a00\u3059\u308b\u3002\u307e\u305f\u3001PMS\u306e\u983b\u5ea6\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u5bc4\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306e\u91cf\u3084\u7a2e\u985e\u306b\u3088\u3063\u3066\u3082\u7570\u306a\u308a\u307e\u3059\u3002\u30f4\u30a3\u30b8\u30e9\u30f3\u30b9\u5831\u544a\u306e\u4e3b\u306a\u6c7a\u5b9a\u8981\u56e0\u306e\u4e00\u3064\u306f\u3001\u3055\u3089\u306a\u308b\u30a2\u30af\u30b7\u30e7\u30f3\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3001\u82e6\u60c5\u3084\u30d5\u30a3\u30fc\u30c9\u30d0\u30c3\u30af\u306e\u8a55\u4fa1\u3067\u3059\u3002\u8b66\u6212\u30b7\u30b9\u30c6\u30e0\u3092\u9069\u5207\u306b\u5b9f\u65bd\u3059\u308b\u305f\u3081\u306b\u306f\u3001\u30e6\u30fc\u30b6\u30fc\u3092\u5dfb\u304d\u8fbc\u3093\u3067\u5354\u529b\u3092\u6c42\u3081\u308b\u3068\u3068\u3082\u306b\u3001\u30e1\u30fc\u30ab\u30fc\u3001\u4ed6\u306e\u6240\u8f44\u5b98\u5e81\u3001\u8b66\u6212\u30b7\u30b9\u30c6\u30e0\u3092\u52b9\u679c\u7684\u306b\u4fc3\u9032\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u95a2\u9023\u30e6\u30fc\u30b6\u30fc\u30b0\u30eb\u30fc\u30d7\u3092\u5dfb\u304d\u8fbc\u3080\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Benefits_of_Post-Market_Surveillance\"><\/span>\u5e02\u8ca9\u5f8c\u8abf\u67fb\u306e\u30e1\u30ea\u30c3\u30c8<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u9069\u5207\u306b\u5b9f\u88c5\u3055\u308c\u305f\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u306f\u3001\u4ee5\u524d\u306b\u306f\u78ba\u8a8d\u3055\u308c\u3066\u3044\u306a\u304b\u3063\u305f\u672a\u77e5\u306e\u6709\u5bb3\u88fd\u54c1\u60c5\u5831\u3092\u691c\u51fa\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3057\u3066\u3001\u6df1\u523b\u306a\u5065\u5eb7\u72b6\u614b\u306e\u60aa\u5316\u3084\u6b7b\u4ea1\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u4e8b\u6545\u3084\u6709\u5bb3\u4e8b\u8c61\u306f\u3001\u9069\u5207\u306b\u5c0e\u5165\u3055\u308c\u305f\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u306b\u3088\u3063\u3066\u518d\u767a\u3092\u9632\u3050\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u79c1\u306f\u3001\u30d3\u30b8\u30e9\u30f3\u30b9\u30b7\u30b9\u30c6\u30e0\u304c\u3001\u672a\u77e5\u306e\u88fd\u9020\u4e0a\u306e\u554f\u984c\u306e\u60c5\u5831\u6e90\u3068\u306a\u3063\u305f\u30b1\u30fc\u30b9\u3092\u898b\u3066\u304d\u307e\u3057\u305f\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u9069\u5207\u306b\u5c0e\u5165\u3055\u308c\u305f\u30d3\u30b8\u30e9\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u306e\u305d\u306e\u4ed6\u306e\u5229\u70b9\u3068\u3057\u3066\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u8a2d\u8a08\u8a55\u4fa1\u3084\u3001\u533b\u7642\u6a5f\u5668\u306e\u30ea\u30b9\u30af\u3068\u81e8\u5e8a\u7684\u5229\u76ca\u306e\u6bd4\u7387\u306e\u8a55\u4fa1\u304c\u6319\u3052\u3089\u308c\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u9023\u3059\u308b\u30ea\u30b9\u30af\u304c\u3001\u30a8\u30f3\u30c9\u30e6\u30fc\u30b6\u30fc\u306b\u63d0\u4f9b\u3067\u304d\u308b\u81e8\u5e8a\u4e0a\u306e\u5229\u76ca\u3088\u308a\u3082\u76f8\u5bfe\u7684\u306b\u4f4e\u3044\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u533b\u7642\u6a5f\u5668\u306e\u554f\u984c\u3092\u89e3\u6c7a\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\u306e\u8a2d\u8a08\u3084\u88fd\u9020\u306e\u5909\u66f4\u3001\u6839\u672c\u539f\u56e0\u306e\u89e3\u6c7a\u3001\u88fd\u54c1\u306e\u30e9\u30d9\u30ea\u30f3\u30b0\u3001\u5c06\u6765\u306e\u767a\u751f\u3092\u9632\u3050\u305f\u3081\u306e\u30c8\u30ec\u30fc\u30cb\u30f3\u30b0\u306a\u3069\u3001\u662f\u6b63\u63aa\u7f6e\u3084\u4e88\u9632\u63aa\u7f6e\uff08CAPA\uff09\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u969b\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u30d3\u30b8\u30e9\u30f3\u30c8\u30b7\u30b9\u30c6\u30e0\u3092\u901a\u3058\u3066\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306f\u3001\u30ea\u30b9\u30af\u30de\u30cd\u30b8\u30e1\u30f3\u30c8\u30d5\u30a1\u30a4\u30eb\u3084\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\uff08CER\uff09\u306a\u3069\u306e\u6587\u66f8\u306b\u53cd\u6620\u3055\u308c\u307e\u3059\u3002\u8b66\u6212\u30b7\u30b9\u30c6\u30e0\u304b\u3089\u306e\u3053\u308c\u3089\u306e\u65b0\u3057\u3044\u30c7\u30fc\u30bf\u306f\u3001\u4ee5\u524d\u306b\u6587\u66f8\u5316\u3055\u308c\u3066\u3044\u306a\u304b\u3063\u305f\u66f4\u306a\u308b\u30ea\u30b9\u30af\u3092\u7279\u5b9a\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u3060\u3051\u3067\u306a\u304f\u3001\u30ea\u30b9\u30af\u304c\u307e\u3060\u8a31\u5bb9\u7bc4\u56f2\u5185\u306b\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u793a\u3059\u306e\u306b\u3082\u5f79\u7acb\u3061\u307e\u3059\u3002CER\u306f\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u3092\u8a55\u4fa1\u30fb\u5206\u6790\u3057\u3001\u6a5f\u5668\u306e\u81e8\u5e8a\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u691c\u8a3c\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7b2c85\u6761\u304a\u3088\u3073\u7b2c86\u6761\u306f\u3001MDR\u306e\u4e0b\u3067\u306ePMS\u306e\u65b0\u3057\u3044\u8981\u4ef6\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002PMS\u3067\u53ce\u96c6\u3055\u308c\u305f\u30c7\u30fc\u30bf\u306f\u3001\u4ee5\u4e0b\u306e\u76ee\u7684\u3067\u4f7f\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059[2]\u3002\u00a0<\/span><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30ea\u30b9\u30af\u3068\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u306e\u6bd4\u7387\u3092\u6c7a\u5b9a\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u3092\u4fee\u6b63\u307e\u305f\u306f\u6539\u8a02\u3057\u3001\uff08\u5fc5\u8981\u306b\u5fdc\u3058\u3066\uff09\u30ea\u30b9\u30af\u7ba1\u7406\u3092\u4fee\u6b63\u3059\u308b\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">PMS\u306b\u57fa\u3065\u3044\u3066\u3001\u8a2d\u8a08\u60c5\u5831\u307e\u305f\u306f\u88fd\u9020\u60c5\u5831\u307e\u305f\u306f\u305d\u306e\u4e21\u65b9\u3092\u6539\u8a02\u3059\u308b\u3002\u3053\u308c\u306b\u306f\u3001\u6a5f\u5668\u306e\u53d6\u6271\u8aac\u660e\u66f8\u3084\u30e9\u30d9\u30ea\u30f3\u30b0\u306e\u6539\u8a02\u3082\u542b\u307e\u308c\u307e\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u3068\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u8a55\u4fa1\u306e\u898b\u76f4\u3057\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u7684\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u306e\u6982\u8981\u3092\u66f4\u65b0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CAPA\u306e\u5fc5\u8981\u6027\u3002\u662f\u6b63\u63aa\u7f6e\u304a\u3088\u3073\u4e88\u9632\u63aa\u7f6e\u306e\u8981\u4ef6\u306e\u7279\u5b9a\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u306e\u4f7f\u3044\u3084\u3059\u3055\u3001\u6027\u80fd\u3001\u304a\u3088\u3073\/\u307e\u305f\u306f\u5b89\u5168\u6027\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306e\u69d8\u3005\u306a\u30aa\u30d7\u30b7\u30e7\u30f3\u306e\u7279\u5b9a\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u30c8\u30ec\u30f3\u30c9\u30ec\u30dd\u30fc\u30c8<\/span><\/li>\n<\/ol>\n<h3><span class=\"ez-toc-section\" id=\"Medical_Device_Post-Market_Surveillance_Summary_of_report_timelines\"><\/span><strong>\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5831\u544a\u66f8\u306e\u30bf\u30a4\u30e0\u30e9\u30a4\u30f3\u306e\u6982\u8981<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<table>\n<tbody>\n<tr>\n<td><b>\u30af\u30e9\u30b9I<\/b><\/td>\n<td><b>\u30af\u30e9\u30b9IIa<\/b><\/td>\n<td><b>\u30af\u30e9\u30b9IIb<\/b><\/td>\n<td><b>\u30af\u30e9\u30b9III<\/b><\/td>\n<td><b>\u690d\u8fbc\u307f\u578b<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">PMSR<\/span><\/td>\n<td colspan=\"4\"><span style=\"font-weight: 400;\">PSUR (\u30c7\u30d0\u30a4\u30b9\u306e\u30e9\u30a4\u30d5\u30bf\u30a4\u30e0\u3092\u901a\u3057\u3066)<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">\u5fc5\u8981\u306b\u5fdc\u3058\u3066<\/span><\/td>\n<td><span style=\"font-weight: 400;\">\u5fc5\u8981\u306b\u5fdc\u3058\u3066<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u304c\u3001\u5c11\u306a\u304f\u3068\u3082<\/span><\/p>\n<p><span style=\"font-weight: 400;\">2\u5e74\u3054\u3068<\/span><\/td>\n<td colspan=\"3\"><span style=\"font-weight: 400;\">\u5e741\u56de<\/span><\/td>\n<\/tr>\n<tr>\n<td><\/td>\n<td><span style=\"font-weight: 400;\">NB\uff08\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff09\u3078\u306e\u63d0\u4f9b<\/span><\/td>\n<td colspan=\"3\"><span style=\"font-weight: 400;\">\u96fb\u5b50\u30c7\u30fc\u30bf\u3092NB\u306b\u63d0\u51fa<\/span><\/td>\n<\/tr>\n<tr>\n<td colspan=\"3\"><span style=\"font-weight: 400;\">\u4e3b\u52d9\u5b98\u5e81\u306e\u8981\u8acb\u306b\u5fdc\u3058\u3066\u63d0\u4f9b\u3059\u308b<\/span><\/td>\n<td colspan=\"2\"><span style=\"font-weight: 400;\">\u30b3\u30f3\u30d4\u30c6\u30f3\u30b7\u30fc\u306b\u5229\u7528\u3067\u304d\u308b<\/span><\/p>\n<p><span style=\"font-weight: 400;\">NC\u306b\u3088\u308b\u6a29\u9650<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u8981\u7d04\u3059\u308b\u3068\u3001PMS\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u3092\u901a\u3058\u3066\u7d99\u7d9a\u7684\u306b\u884c\u308f\u308c\u308b\u30ec\u30d3\u30e5\u30fc\u3068\u30ea\u30b9\u30af\u8a55\u4fa1\u306e\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308a\u3001\u4e00\u56de\u9650\u308a\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3068\u3057\u3066\u8003\u3048\u308b\u3079\u304d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u533b\u7642\u6a5f\u5668\u306e\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u3084\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6b20\u9665\u306e\u6e1b\u5c11\u3001\u30e6\u30fc\u30b6\u30fc\u306e\u5b89\u5168\u6027\u306e\u5411\u4e0a\u3001\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u8a34\u8a1f\u30ea\u30b9\u30af\u306e\u6e1b\u5c11\u306a\u3069\u306e\u5229\u76ca\u3092\u6700\u5927\u5316\u3059\u308b\u305f\u3081\u306b\u3001PMS\u30d7\u30ed\u30bb\u30b9\u3092\u5168\u4f53\u7684\u306a\u30a2\u30d7\u30ed\u30fc\u30c1\u3068\u3057\u3066\u6349\u3048\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002PMS\u30d7\u30ed\u30bb\u30b9\u306b\u4e0d\u53ef\u6b20\u306a\u30c4\u30fc\u30eb\u306f\u3001\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\/\u30ea\u30a2\u30af\u30c6\u30a3\u30d6PMS\u3068\u8b66\u6212\u5fc3\u3067\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u8005\u3084\u88fd\u9020\u8005\u306f\u3001PMS\u30b7\u30b9\u30c6\u30e0\u304c\u5358\u306a\u308b\u898f\u5236\u8981\u4ef6\u3067\u306f\u306a\u304f\u3001\u533b\u7642\u6a5f\u5668\u306e\u54c1\u8cea\u7ba1\u7406\u30d7\u30ed\u30bb\u30b9\u3067\u3042\u308b\u3053\u3068\u3092\u8a8d\u8b58\u3057\u307e\u3059\u3002\u3053\u306e\u30b7\u30b9\u30c6\u30e0\u306e\u305f\u3081\u306e\u9053\u5177\u306f\u3001\u30ea\u30a2\u30af\u30c6\u30a3\u30d6\u304a\u3088\u3073\u30d7\u30ed\u30a2\u30af\u30c6\u30a3\u30d6\u306a\u8981\u7d20\u3068\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u5b9f\u8a3c\uff0f\u6587\u66f8\u5316\u3067\u69cb\u6210\u3055\u308c\u3066\u3044\u308b\u3002PMS\u306e\u9069\u5207\u306a\u5b9f\u65bd\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6210\u529f\u306b\u4e0d\u53ef\u6b20\u3067\u91cd\u8981\u306a\u8981\u7d20\u3067\u3042\u308a\u3001PMS\u306e\u5b9f\u65bd\u624b\u9806\u306b\u306f\u3001\u30c7\u30fc\u30bf\u53ce\u96c6\u3001\u30ec\u30d3\u30e5\u30fc\u3001\u304a\u3088\u3073\u5b9f\u65bd\u306b\u5bfe\u3059\u308b\u30b3\u30df\u30c3\u30c8\u30e1\u30f3\u30c8\u3092\u53cd\u6620\u3055\u305b\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u533b\u7642\u6a5f\u5668\u306ePMS\u3067\u304a\u56f0\u308a\u3067\u3059\u304b\uff1f\u3092\u898b\u3066\u307f\u307e\u3057\u3087\u3046\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u5e02\u8ca9\u5f8c\u8abf\u67fb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> \u3092Kolabtree\u306b\u63b2\u8f09\u3057\u307e\u3057\u305f\u3002\u00a0<\/strong><\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/Post-Market-Clinical-Followup\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">PMCF\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8\u4f5c\u6210\u8005<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/FDA-Submissions\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">FDA\u7533\u8acb\u30b3\u30f3\u30b5\u30eb\u30bf\u30f3\u30c8\u00a0<\/a><\/strong><\/p>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/b><\/p>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MDR\u7b2c1\u7ae0\u7b2c2\u6761\uff0860\uff09\u3001IVDR\u7b2c1\u7ae0\u7b2c2\u6761\uff0863\uff09\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">MDR\u7b2c7\u7ae0\u7b2c1\u7bc0\/IVDR\u7b2c7\u7ae0\u7b2c1\u7bc0<\/span><\/li>\n<\/ol>\n<p><strong>\u3053\u306e\u30b7\u30ea\u30fc\u30ba\u306e\u5168\u8a18\u4e8b<br \/>\n<\/strong><a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-and-design-a-definitive-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u958b\u767a\u30fb\u8a2d\u8a08\u306e\u305f\u3081\u306e\u6c7a\u5b9a\u7248\u30ac\u30a4\u30c9<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-development-3-tips-for-success\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u958b\u767a\u3002\u6210\u529f\u306e\u305f\u3081\u306e3\u3064\u306e\u30d2\u30f3\u30c8<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-design-the-essential-step-by-step-guide\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u30c7\u30b6\u30a4\u30f3\u3002The Essential, Step-by-Step Guide<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-commercialization-9-steps-from-sketch-to-launch\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u54c1\u5316\uff1a\u30b9\u30b1\u30c3\u30c1\u304b\u3089\u767a\u58f2\u307e\u3067\u306e9\u3064\u306e\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.biotechnologynewsmagazine.infomeddnews.com\/how-to-overcome-medical-device-commercialization-challenges-best-practices\/\">\u533b\u7642\u6a5f\u5668\u306e\u5546\u696d\u5316\u306e\u8ab2\u984c\u3092\u3069\u3046\u514b\u670d\u3059\u308b\u304b<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-launch-key-steps-when-taking-product-to-market\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u30ed\u30fc\u30f3\u30c1\u88fd\u54c1\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u305f\u3081\u306e\u91cd\u8981\u306a\u30b9\u30c6\u30c3\u30d7<\/a><br \/>\n<a href=\"https:\/\/www.kolabtree.com\/blog\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=PMS6\">\u533b\u7642\u6a5f\u5668\u306e\u5e02\u8ca9\u5f8c\u8abf\u67fb\u3002\u5305\u62ec\u7684\u306a\u30ac\u30a4\u30c9<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Shrinidh Joshi, medtech consultant on Kolabtree, provides a comprehensive guide to medical device post-market surveillance (PMS), including how to implement a PMS system.\u00a0\u00a0 In the previous articles, we have discussed taking an idea from the back of the napkin design to the commercialization stage. A successful medical device launch is certainly a moment of celebration for all the stakeholders. However, after the entry of the medical device into the market, your job is not over, you also need to ensure that your medical device continues to be safe and effective. This process of ensuring the safety of the device after its launch is commonly referred to as medical post-market surveillance<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":8868,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Medical Device Post-Market Surveillance: A Comprehensive Guide<\/title>\n<meta name=\"description\" content=\"The ultimate guide to medical device post-market surveillance: what it should include, proactive &amp; reactive actions, and important timelines.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical Device Post-Market Surveillance: A Comprehensive Guide\" \/>\n<meta property=\"og:description\" content=\"The ultimate guide to medical device post-market surveillance: what it should include, proactive &amp; reactive actions, and important timelines.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/a-comprehensive-guide-to-medical-device-post-market-surveillance\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta 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