{"id":7601,"date":"2020-05-18T16:39:32","date_gmt":"2020-05-18T16:39:32","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7601"},"modified":"2020-11-09T08:20:39","modified_gmt":"2020-11-09T08:20:39","slug":"the-impact-of-covid-19-on-the-medical-device-industry","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/","title":{"rendered":"COVID-19\u306e\u533b\u7642\u6a5f\u5668\u696d\u754c\u3078\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066"},"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-69f6235997e14\" 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-69f6235997e14\"><\/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\/the-impact-of-covid-19-on-the-medical-device-industry\/#At_present_from_covid-19_impact_on_medical_devices_market_this_is_what_we_know_about_specific_regulatory_impacts\" title=\"\u73fe\u5728\u3001covid-19\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u5f71\u97ff\u304b\u3089\u3001\u5177\u4f53\u7684\u306a\u898f\u5236\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u308f\u304b\u3063\u3066\u3044\u308b\u3053\u3068\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002\">\u73fe\u5728\u3001covid-19\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u5f71\u97ff\u304b\u3089\u3001\u5177\u4f53\u7684\u306a\u898f\u5236\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u308f\u304b\u3063\u3066\u3044\u308b\u3053\u3068\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002\n<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#1_Impact_of_COVID-19_on_regulatory_approvals_in_EU\" title=\"1.COVID-19\u304cEU\u3067\u306e\u85ac\u4e8b\u627f\u8a8d\u306b\u4e0e\u3048\u308b\u5f71\u97ff\">1.COVID-19\u304cEU\u3067\u306e\u85ac\u4e8b\u627f\u8a8d\u306b\u4e0e\u3048\u308b\u5f71\u97ff<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#2_Impact_of_COVID-19_on_regulatory_approvals_in_the_US\" title=\"2.COVID-19\u306e\u7c73\u56fd\u306b\u304a\u3051\u308b\u85ac\u4e8b\u627f\u8a8d\u3078\u306e\u5f71\u97ff\">2.COVID-19\u306e\u7c73\u56fd\u306b\u304a\u3051\u308b\u85ac\u4e8b\u627f\u8a8d\u3078\u306e\u5f71\u97ff<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#3_Medical_device_shortage_and_exemptions_for_COVID-19_related_devices\" title=\"3.COVID-19\u95a2\u9023\u6a5f\u5668\u306e\u533b\u7642\u6a5f\u5668\u4e0d\u8db3\u3068\u9069\u7528\u9664\u5916\u306b\u3064\u3044\u3066\">3.COVID-19\u95a2\u9023\u6a5f\u5668\u306e\u533b\u7642\u6a5f\u5668\u4e0d\u8db3\u3068\u9069\u7528\u9664\u5916\u306b\u3064\u3044\u3066<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#4_Impact_of_COVID-19_on_personal_protective_equipment_PPE\" title=\"4.\u500b\u4eba\u7528\u4fdd\u8b77\u5177\uff08PPE\uff09\u306b\u5bfe\u3059\u308bCOVID-19\u306e\u5f71\u97ff\">4.\u500b\u4eba\u7528\u4fdd\u8b77\u5177\uff08PPE\uff09\u306b\u5bfe\u3059\u308bCOVID-19\u306e\u5f71\u97ff<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#5_Impact_of_COVID-19_on_medical_device_grant_funding\" title=\"5.COVID-19\u306e\u533b\u7642\u6a5f\u5668\u52a9\u6210\u91d1\u3078\u306e\u5f71\u97ff\">5.COVID-19\u306e\u533b\u7642\u6a5f\u5668\u52a9\u6210\u91d1\u3078\u306e\u5f71\u97ff<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#6_Impact_on_clinical_trials_and_IRB_reviews\" title=\"6.\u81e8\u5e8a\u8a66\u9a13\u3084IRB\u5be9\u67fb\u3078\u306e\u5f71\u97ff\">6.\u81e8\u5e8a\u8a66\u9a13\u3084IRB\u5be9\u67fb\u3078\u306e\u5f71\u97ff<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/#Summary\" title=\"\u6982\u8981\">\u6982\u8981<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\"><em><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7<\/a>\u3001\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"> \u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30e9\u30a4\u30bf\u30fc<\/a> \u3068\u81e8\u5e8a <a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">\u30ea\u30b5\u30fc\u30c1<\/a> expert on Kolabtree, outlines the covid-19 impact on medical devices market, including regulatory approvals, clinical trials and PPE.<\/em><\/span><\/p>\n<p>2020\u5e745\u6708\u521d\u65ec\u6642\u70b9\u3067\u3001470\u4e07\u4eba\u4ee5\u4e0a\u306eSARS-CoV-2\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3078\u306e\u611f\u67d3\u304c\u78ba\u8a8d\u3055\u308c\u3066\u3044\u308b[<span style=\"font-weight: 400;\">1]<\/span><span style=\"font-weight: 400;\">\u305d\u306e\u305f\u3081\u3001\u5404\u56fd\u653f\u5e9c\u306f\u305d\u306e\u62e1\u5927\u3092\u6291\u3048\u308b\u305f\u3081\u306b\u5954\u8d70\u3057\u3066\u3044\u307e\u3059\u3002\u9ad8\u3044R<\/span><span style=\"font-weight: 400;\">0<\/span><span style=\"font-weight: 400;\"> \u5024\uff08\u4f1d\u67d3\u529b\u306e\u6307\u6a19\u3067\u30012.0\uff5e3.0\u3068\u63a8\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">2<\/span><span style=\"font-weight: 400;\">SARS-CoV-2\u306f\u3001\u611f\u67d3\u8005\u304c\u5927\u91cf\u306b\u30a6\u30a4\u30eb\u30b9\u3092\u307e\u304d\u6563\u3089\u3057\u3001\u7a81\u7136\u3001\u5408\u4f75\u75c7\u3092\u767a\u75c7\u3059\u308b\u3002\u305d\u306e\u7d50\u679c\u3001\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306b\u8ca0\u62c5\u304c\u304b\u304b\u308a\u3001\u3059\u3079\u3066\u306e\u60a3\u8005\u306b\u52b9\u679c\u7684\u306b\u533b\u7642\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u4e16\u754c\u4e2d\u3067\u8ab2\u984c\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u521d\u671f\u75c7\u72b6\u3078\u306e\u914d\u616e\u304c\u4e0d\u5341\u5206\u3067\u3042\u3063\u305f\u3053\u3068\u3001\u5099\u84c4\u304c\u4e0d\u5341\u5206\u3067\u3042\u3063\u305f\u3053\u3068\u3001\u691c\u67fb\u30ad\u30c3\u30c8\u3084\u500b\u4eba\u9632\u8b77\u5177\uff08PPE\uff09\u304c\u5165\u624b\u3067\u304d\u306a\u304b\u3063\u305f\u3053\u3068\u3001\u691c\u67fb\u65b9\u6cd5\u3084PPE\u306e\u914d\u5e03\u65b9\u6cd5\u3001\u793e\u4f1a\u7684\u8ddd\u96e2\u3092\u7f6e\u304f\u63aa\u7f6e\u306e\u6642\u671f\u3084\u7a0b\u5ea6\u306b\u5168\u56fd\u7684\u306a\u3070\u3089\u3064\u304d\u304c\u3042\u3063\u305f\u3053\u3068\u306a\u3069\u304c\u611f\u67d3\u62e1\u5927\u306b\u5f71\u97ff\u3057\u305f\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002\u4e0d\u5341\u5206\u306aPPE\u3001\u904e\u5bc6\u72b6\u614b\u3001\u65e2\u5b58\u306e\u60a3\u8005\u3092\u4fdd\u8b77\u3059\u308b\u3053\u3068\u306e\u96e3\u3057\u3055\u306f\u3001\u533b\u7642\u696d\u754c\u304c\u53d6\u308a\u7d44\u3093\u3067\u3044\u308b\u4e3b\u8981\u306a\u8ab2\u984c\u3067\u3042\u308b covid-19 \u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u5f71\u97ff[<\/span><span style=\"font-weight: 400;\">3]<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3082\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u5f71\u97ff\u304b\u3089\u9003\u308c\u308b\u3053\u3068\u306f\u3067\u304d\u307e\u305b\u3093\u3002\u88fd\u85ac\u4f1a\u793e\u3068\u540c\u69d8\u306b\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3082\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u53ce\u96c6\u3092\u533b\u7642\u6a5f\u95a2\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002\u307b\u3068\u3093\u3069\u306e\u533b\u7642\u6a5f\u5668\u88fd\u54c1\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u5e02\u5834\u627f\u8a8d\u306e\u305f\u3081\u306e\u8a3c\u660e\u66f8\u3092\u53d6\u5f97\u3059\u308b\u524d\u306b\u3001\u5e02\u8ca9\u524d\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u306e\u4e21\u65b9\u306e\u81e8\u5e8a\u8a66\u9a13\u3092\u53d7\u3051\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u88fd\u85ac\u4f1a\u793e\u3068\u540c\u69d8\u306b <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/covid-19\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">COVID-19<\/a> \u30d1\u30f3\u30c7\u30df\u30c3\u30af\u304c\u7d9a\u304f\u4e2d\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u4e0d\u78ba\u5b9f\u6027\u306e\u4e2d\u3067\u3001\u88fd\u54c1\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3001\u898f\u5236\u4e0a\u306e\u7fa9\u52d9\u306b\u3064\u3044\u3066\u5341\u5206\u306a\u60c5\u5831\u3092\u5f97\u305f\u4e0a\u3067\u5224\u65ad\u3059\u308b\u3053\u3068\u304c\u56f0\u96e3\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306e\u5c02\u9580\u5bb6\u306f\u3001\u30d1\u30cb\u30c3\u30af\u306e\u4e2d\u3067\u4e00\u65e6\u505c\u6b62\u3092\u6c42\u3081\u308b\u3068\u3044\u3046\u4e0d\u540d\u8a89\u306a\u4efb\u52d9\u3092\u62c5\u3063\u3066\u3044\u307e\u3059\u3002\u73fe\u5728\u306e\u72b6\u6cc1\u304c\u3069\u3093\u306a\u306b\u60aa\u304f\u3066\u3082\u3001\u3042\u308b\u3044\u306f\u60aa\u304f\u306a\u308b\u304b\u3082\u3057\u308c\u306a\u304f\u3066\u3082\u3001\u7121\u9813\u7740\u306a\u884c\u52d5\u306f\u4e8b\u614b\u3092\u60aa\u5316\u3055\u305b\u308b\u3068\u3044\u3046\u306e\u304c\u771f\u5b9f\u3067\u3059\u3002\u30a2\u30c9\u30ec\u30ca\u30ea\u30f3\u304c\u300c\u65e9\u304f\u4f5c\u308c\u300d\u3068\u8a00\u3063\u3066\u3044\u308b\u306b\u3082\u304b\u304b\u308f\u3089\u305a\u3001\u4eca\u3053\u305d\u54c1\u8cea\u304c\u4f55\u3088\u308a\u3082\u91cd\u8981\u306a\u306e\u3067\u3042\u308b\u3002 covid-19\u304c\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u4e0e\u3048\u308b\u5f71\u97ff<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u9069\u7528\u9664\u5916\u3092\u6d3b\u7528\u3057\u305f\u6226\u7565\u3001\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u305f\u3081\u306e\u9769\u65b0\u7684\u306a\u88fd\u9020\u624b\u9806\u3001\u5b98\u6c11\u3092\u8d85\u3048\u305f\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30d7\u30e9\u30f3\u304c\u3042\u308c\u3070\u3001\u6df7\u6c8c\u3068\u3057\u305f\u72b6\u6cc1\u3092\u4e57\u308a\u5207\u308a\u3001\u516c\u8846\u885b\u751f\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u696d\u754c\u306e\u6210\u529f\u306e\u9375\u3092\u63e1\u308b\u306e\u306f\u3001\u653f\u5e9c\u6a5f\u95a2\u304b\u3089\u306e\u767a\u8868\u3068\u3001\u4e3b\u8981\u306a\u610f\u601d\u6c7a\u5b9a\u8005\u3084\u898f\u5236\u5c02\u9580\u5bb6\u3068\u306e\u5bfe\u8a71\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u5168\u4f53\u3068\u3057\u3066\u3001\u3044\u304f\u3064\u304b\u306e\u65b0\u3057\u3044\u898f\u5236\u306e\u5b9f\u65bd\u304c\u5ef6\u671f\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001\u4f01\u696d\u3068\u898f\u5236\u5f53\u5c40\u306e\u53cc\u65b9\u304c\u5371\u6a5f\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306e\u6642\u9593\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u3053\u308c\u306b\u3088\u3063\u3066\u65e2\u5b58\u306e\u6cd5\u898f\u5236\u306e\u5831\u544a\u671f\u9650\u304c\u5909\u66f4\u3055\u308c\u308b\u3068\u3044\u3046\u8a3c\u62e0\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<h3><span class=\"ez-toc-section\" id=\"At_present_from_covid-19_impact_on_medical_devices_market_this_is_what_we_know_about_specific_regulatory_impacts\"><\/span><span style=\"font-weight: 400;\">\u73fe\u5728\u3001covid-19\u306e\u533b\u7642\u6a5f\u5668\u5e02\u5834\u3078\u306e\u5f71\u97ff\u304b\u3089\u3001\u5177\u4f53\u7684\u306a\u898f\u5236\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u308f\u304b\u3063\u3066\u3044\u308b\u3053\u3068\u306f\u4ee5\u4e0b\u306e\u901a\u308a\u3067\u3059\u3002<br \/>\n<\/span><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<h2><span class=\"ez-toc-section\" id=\"1_Impact_of_COVID-19_on_regulatory_approvals_in_EU\"><\/span><b>1.COVID-19\u304cEU\u3067\u306e\u85ac\u4e8b\u627f\u8a8d\u306b\u4e0e\u3048\u308b\u5f71\u97ff<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6b27\u5dde\u9023\u5408\uff08EU\uff09\u3067\u306f <a href=\"https:\/\/www.kolabtree.com\/services\/eu-mdr-consulting\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">\u533b\u7642\u6a5f\u5668\u898f\u5236<\/a> (MDR\uff09\u3067\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u306f\u5e02\u8ca9\u5f8c\u306e\u81e8\u5e8a\u30d5\u30a9\u30ed\u30fc\u30a2\u30c3\u30d7\uff08PMCF\uff09\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u3001\u6a5f\u5668\u306e\u7d99\u7d9a\u7684\u306a\u5b89\u5168\u6027\u3068\u6027\u80fd\u3092\u5b9f\u8a3c\u3059\u308b\u3068\u3068\u3082\u306b\u3001\u65b0\u305f\u306b\u767a\u751f\u3059\u308b\u30ea\u30b9\u30af\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3057\u304b\u3057\u3001COVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u3088\u308a\u3001\u81e8\u5e8a\u8a66\u9a13\u304c\u9045\u308c\u3001\u30d7\u30ed\u30bb\u30b9\u304c\u6df7\u4e71\u3057\u307e\u3057\u305f\u3002\u6cbb\u9a13\u8cac\u4efb\u533b\u5e2b\u4e3b\u5c0e\u578b\u8a66\u9a13\uff08IIS\uff09\u306e\u3088\u3046\u306a\u7279\u5b9a\u306e\u8a66\u9a13\u306f\u3001\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u5168\u4f53\u304c\u7279\u5b9a\u306e\u6cbb\u7642\u6cd5\u306e\u6709\u52b9\u6027\u306b\u3064\u3044\u3066\u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u3092\u5f97\u308b\u305f\u3081\u306b\u5fc5\u8981\u3067\u3059\u304c\u3001\u305d\u306e\u4ed6\u306e\u81e8\u5e8a\u8a66\u9a13\u306f\u3001\u898f\u5236\u8981\u4ef6\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u6a5f\u5668\u306e\u5b89\u5168\u6027\u3068\u81e8\u5e8a\u6027\u80fd\u3092\u8abf\u67fb\u3059\u308b\u305f\u3081\u306b\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u958b\u59cb\u3057\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">COVID-19\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u3088\u308a\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u5148\u65e5\u30012020\u5e744\u67083\u65e5\u306bMDR\u306e\u9069\u7528\u65e5\u30921\u5e74\u9593\u5ef6\u671f\u3059\u308b\u63d0\u6848\u3092\u63a1\u629e\u3057\u307e\u3057\u305f\u3002\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u58f0\u660e\u306e\u4e2d\u3067\u3001\u300c\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u5371\u6a5f\u306b\u3088\u308a\u3001\u7279\u5b9a\u306e\u91cd\u8981\u306a\u533b\u7642\u6a5f\u5668\u306b\u5bfe\u3059\u308b\u9700\u8981\u304c\u9ad8\u307e\u308b\u4e2d\u3001\u533b\u7642\u6a5f\u5668\u898f\u5247\u306e\u5b9f\u65bd\u306b\u95a2\u9023\u3059\u308b\u5f53\u5c40\u3084\u9069\u5408\u6027\u8a55\u4fa1\u6a5f\u95a2\u306e\u80fd\u529b\u5236\u9650\u306b\u8d77\u56e0\u3059\u308b\u3001\u6f5c\u5728\u7684\u306a\u4e0d\u8db3\u3084\u5229\u7528\u53ef\u80fd\u6027\u306e\u9045\u5ef6\u3068\u3044\u3063\u305f\u3001\u3055\u3089\u306a\u308b\u56f0\u96e3\u3084\u30ea\u30b9\u30af\u3092\u56de\u907f\u3059\u308b\u3053\u3068\u304c\u6975\u3081\u3066\u91cd\u8981\u3067\u3042\u308b\u300d\u3068\u8a18\u3057\u3066\u3044\u308b\u3002\u3053\u306e\u63d0\u6848\u306b\u57fa\u3065\u304d\u3001\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff08EUDAMED\uff09\u306e\u6a5f\u80fd\u306f\u3001\u4ee3\u308f\u308a\u306b2021\u5e743\u670825\u65e5\u307e\u3067\u306b\u767a\u8868\u3055\u308c\u3001\u5831\u544a\u7fa9\u52d9\u306f2021\u5e745\u670826\u65e5\u304b\u3089\u3068\u306a\u308b\u3002\u5831\u544a\u7fa9\u52d9\u304c\u5ef6\u671f\u3055\u308c\u305f\u3068\u306f\u3044\u3048\u3001\u4f01\u696d\u306f\u5341\u5206\u306a\u6642\u9593\u3092\u304b\u3051\u3066\u3053\u306e\u671f\u9650\u306b\u9593\u306b\u5408\u308f\u305b\u308b\u305f\u3081\u306b\u3001\u6765\u5e74\u306e3\u6708\u307e\u3067\u306b\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u30c7\u30fc\u30bf\u3092\u307e\u3068\u3081\u3001\u63d0\u51fa\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3092\u76ee\u6307\u3059\u3079\u304d\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">EU MDR\u3067\u306f\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u5927\u304d\u306a\u5909\u5316\u304c\u3042\u308a\u307e\u3057\u305f\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u81e8\u5e8a\u8a55\u4fa1\u306e\u8981\u4ef6\u306e\u5897\u52a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30c7\u30b8\u30bf\u30eb\u3068\u30d5\u30a3\u30b8\u30ab\u30eb\u306e\u30e9\u30d9\u30ea\u30f3\u30b0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u5e02\u8ca9\u5f8c\u8abf\u67fb\uff08PMS\uff09\u3001\u304a\u3088\u3073<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u30c8\u30fc\u30bf\u30eb\u30e9\u30a4\u30d5\u30b5\u30a4\u30af\u30eb\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u30fc<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08IVDR\uff09\u3084\u3001\u3053\u306e\u9045\u5ef6\u306e\u53ef\u80fd\u6027\u306b\u3088\u308b\u6b27\u5dde\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u76e3\u67fb\u6d3b\u52d5\u3078\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u306f\u3001\u307e\u3060\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u3053\u306e\u307b\u3069\u3001\u533b\u7642\u7528\u30d5\u30a7\u30a4\u30b9\u30de\u30b9\u30af\u3001\u624b\u888b\u3001\u9759\u8108\u6ce8\u5c04\u7528\u5bb9\u5668\u3001\u6ec5\u83cc\u5668\u3001\u6d88\u6bd2\u5264\u306e\u88fd\u9020\u3092\u8fc5\u901f\u5316\u3057\u3001\u6551\u6025\u30fb\u642c\u9001\u7528\u4eba\u5de5\u547c\u5438\u5668\u306e\u7279\u5225\u306a\u8981\u4ef6\u3092\u5909\u66f4\u3059\u308b\u305f\u3081\u3001\u6539\u8a02\u3055\u308c\u305f\u6574\u5408\u898f\u683c\u3092\u63a1\u629e\u3057\u307e\u3057\u305f\u3002\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u3001\u6b27\u5dde\u6a19\u6e96\u5316\u59d4\u54e1\u4f1a\uff08CEN\uff09\u304a\u3088\u3073\u6b27\u5dde\u96fb\u6c17\u6a19\u6e96\u5316\u59d4\u54e1\u4f1a\uff08CENELEC\uff09\u3068\u5354\u529b\u3057\u3066\u3001\u3053\u308c\u3089\u306e\u6574\u5408\u898f\u683c\u306e\u591a\u304f\u3092\u81ea\u7531\u306b\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u306b\u5408\u610f\u3057\u307e\u3057\u305f\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Impact_of_COVID-19_on_regulatory_approvals_in_the_US\"><\/span><b>2.COVID-19\u306e\u7c73\u56fd\u306b\u304a\u3051\u308b\u85ac\u4e8b\u627f\u8a8d\u3078\u306e\u5f71\u97ff<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><strong>\u7dca\u6025\u6642\u306e\u4f7f\u7528\u8a31\u53ef<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u306f\u3001COVID-19\u3092\u8a3a\u65ad\u3059\u308b\u305f\u3081\u306eIVD\u691c\u67fb\u30ad\u30c3\u30c8\u3092\u542b\u3080\u533b\u7642\u6a5f\u5668\u3084\u3001\u60a3\u8005\u3068\u63a5\u3059\u308b\u533b\u7642\u5f93\u4e8b\u8005\u3092\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306aPPE\uff08\u624b\u888b\u3001\u30ac\u30a6\u30f3\u3001\u30de\u30b9\u30af\u306e\u4fdd\u5b58\u3092\u542b\u3080\uff09\u306b\u3064\u3044\u3066\u3001FDA\u304c\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u51fa\u3057\u3066\u3044\u307e\u3059\u3002EUA\u5ba3\u8a00\u306b\u57fa\u3065\u304d\u3001FDA\u306fCOVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u3088\u3046\u306a\u516c\u8846\u885b\u751f\u4e0a\u306e\u5371\u6a5f\u306e\u969b\u306b\u3001\u8fc5\u901f\u306a\u5e02\u8ca9\u524d\u5be9\u67fb\u306b\u3088\u308a\u7279\u5b9a\u306e\u6a5f\u5668\u306e\u8fc5\u901f\u306a\u7dca\u6025\u4f7f\u7528\u3092\u8a31\u53ef\u3059\u308b\u6a29\u9650\u3092\u6709\u3057\u3066\u3044\u307e\u3059\u3002EUA\u306e\u7533\u8acb\u306b\u306f\u3001\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5b89\u5168\u6027\u3001\u6709\u52b9\u6027\u3001\u304a\u3088\u3073\u30ea\u30b9\u30af\u95a2\u9023\u306e\u30c7\u30fc\u30bf\u3092\u5165\u624b\u53ef\u80fd\u306a\u9650\u308a\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002EUA\u3092\u53d6\u5f97\u3059\u308b\u3053\u3068\u3067\u3001\u7c73\u56fd\u306e\u533b\u7642\u5e02\u5834\u3078\u306e\u8fc5\u901f\u306a\u30a2\u30af\u30bb\u30b9\u304c\u53ef\u80fd\u306b\u306a\u308a\u307e\u3059\u304c\u3001\u3053\u308c\u3089\u306e\u8a8d\u53ef\u306f\u3001FDA\u306b\u3088\u3063\u3066\u8a8d\u53ef\u3055\u308c\u305f\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u304c\u767a\u751f\u3057\u3066\u3044\u308b\u9593\u306e\u307f\u6709\u52b9\u3067\u3059\u3002<\/span><\/p>\n<p><strong>\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3 <\/strong><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306f\u3001\u4eba\u5de5\u547c\u5438\u5668\u3001\u4eba\u5de5\u547c\u5438\u5668\u4ed8\u5c5e\u54c1\u3001\u305d\u306e\u4ed6\u306e\u547c\u5438\u5668\u30e1\u30fc\u30ab\u30fc\u3068\u5354\u529b\u3057\u3066\u3001COVID-19\u306e\u30a2\u30a6\u30c8\u30d6\u30ec\u30a4\u30af\u306b\u95a2\u9023\u3059\u308b\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u73fe\u72b6\u3092\u3088\u308a\u3088\u304f\u7406\u89e3\u3057\u3001\u3053\u308c\u3089\u306e\u6a5f\u5668\u306e\u5e83\u7bc4\u306a\u4e0d\u8db3\u3092\u7de9\u548c\u3059\u308b\u3053\u3068\u306b\u52aa\u3081\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><strong>\u30d9\u30f3\u30c1\u30ec\u30fc\u30bf\u30fc\u30ac\u30a4\u30c0\u30f3\u30b9<\/strong><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306f\u3001COVID-19\u60a3\u8005\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306e\u3053\u308c\u3089\u306e\u88fd\u54c1\u306eEUA\u6307\u5b9a\u3092\u4fc3\u9032\u3059\u308b\u4eba\u5de5\u547c\u5438\u5668\u306b\u95a2\u3059\u308b\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u81ea\u52d5\u8eca\u30e1\u30fc\u30ab\u30fc\u3084\u5de5\u696d\u30e1\u30fc\u30ab\u30fc\u306a\u3069\u306e\u975e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306f\u3001\u524d\u4f8b\u306e\u306a\u3044\u3053\u306e\u6642\u671f\u306b\u533b\u7642\u6a5f\u5668\u5206\u91ce\u306b\u53c2\u5165\u3059\u308b\u30c1\u30e3\u30f3\u30b9\u304c\u3042\u308a\u307e\u3059\u304c\u3001FDA\u304c\u4eba\u5de5\u547c\u5438\u5668\u306e\u30cf\u30fc\u30c9\u30a6\u30a7\u30a2\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u3001\u6750\u6599\u306e\u88fd\u9020\u3084\u6539\u9020\u306b\u8981\u6c42\u3059\u308b\u54c1\u8cea\u3001\u5b89\u5168\u6027\u3001\u6027\u80fd\u306e\u57fa\u6e96\u3092\u77e5\u3063\u3066\u304a\u304f\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><strong>3D\u30d7\u30ea\u30f3\u30c8\u3055\u308c\u305fPPE <\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001FDA\u306f\u30013D\u30d7\u30ea\u30f3\u30c8\u3055\u308c\u305fPPE\u30c7\u30d0\u30a4\u30b9\u304a\u3088\u3073\u30b3\u30f3\u30dd\u30fc\u30cd\u30f3\u30c8\u306b\u95a2\u3059\u308b\u6700\u8fd1\u306eFAQ\u3092\u516c\u958b\u3057\u3001\u5f93\u6765\u306e\u88fd\u54c1\u3068\u540c\u7b49\u306e\u4fdd\u8b77\u6a5f\u80fd\u3092\u63d0\u4f9b\u3067\u304d\u306a\u3044\u53ef\u80fd\u6027\u304c\u3042\u308b\u3053\u3068\u3092\u533b\u7642\u5f93\u4e8b\u8005\u306b\u6ce8\u610f\u559a\u8d77\u3057\u3066\u3044\u307e\u3059\u3002\u88fd\u9020\u696d\u8005\u306f\u3001\u30c7\u30d0\u30a4\u30b9\u306e\u8a2d\u8a08\u3001\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\u306e\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u3001\u6750\u6599\u306e\u7ba1\u7406\u3001\u5f8c\u51e6\u7406\u3001\u304a\u3088\u3073\u30d7\u30ed\u30bb\u30b9\u306e\u691c\u8a3c\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u306e\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3\u306b\u95a2\u3059\u308b\u3055\u307e\u3056\u307e\u306a\u63a8\u5968\u4e8b\u9805\u306b\u3064\u3044\u3066\u30013D\u30d7\u30ea\u30f3\u30c8\u306e\u6280\u8853\u7684\u691c\u8a0e\u306b\u95a2\u3059\u308bFDA\u306e\u6700\u7d42\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/blog\/top-fda-regulatory-pathways-for-medical-devices-based-on-classification\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"><strong>\u3053\u3061\u3089\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308bFDA\u898f\u5236\u306e\u30c8\u30c3\u30d7\u30d1\u30b9\u30a6\u30a7\u30a4\u00a0<\/strong><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Medical_device_shortage_and_exemptions_for_COVID-19_related_devices\"><\/span><b>3.COVID-19\u95a2\u9023\u6a5f\u5668\u306e\u533b\u7642\u6a5f\u5668\u4e0d\u8db3\u3068\u9069\u7528\u9664\u5916\u306b\u3064\u3044\u3066<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u4e16\u754c\u7684\u306a\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u9593\u3001\u533b\u7642\u6a5f\u5668\u306e\u898f\u5236\u74b0\u5883\u306f\u3001\u7b2c\u4e00\u7dda\u306e\u533b\u7642\u5f93\u4e8b\u8005\u306b\u5341\u5206\u306aPPE\u3092\u4f9b\u7d66\u3057\u3001\u533b\u7642\u3092\u5fc5\u8981\u3068\u3057\u3066\u3044\u308b\u4eba\u3005\u306b\u6551\u547d\u5177\u3092\u4f9b\u7d66\u3059\u308b\u3068\u3044\u3046\u8ab2\u984c\u306b\u8fc5\u901f\u306b\u5bfe\u5fdc\u3057\u3066\u3044\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3082\u3001\u3053\u306e\u8ab2\u984c\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u306b\u7acb\u3061\u4e0a\u304c\u308a\u3001\u3053\u308c\u3089\u306e\u6a5f\u4f1a\u3092\u5229\u7528\u3057\u3066\u81ea\u793e\u306e\u6a5f\u5668\u3092\u3088\u308a\u65e9\u304f\u5e02\u5834\u306b\u6295\u5165\u3057\u3001COVID-19\u30ab\u30fc\u30d6\u306e\u53cd\u5bfe\u5074\u306b\u7121\u4e8b\u306b\u51fa\u3066\u304f\u308b\u3088\u3046\u306b\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u3053\u306e\u4e16\u754c\u7684\u306a\u5371\u6a5f\u306e\u5f71\u97ff\u3092\u5927\u304d\u304f\u53d7\u3051\u3066\u3044\u308b\u696d\u754c\u306e\u3072\u3068\u3064\u304c\u4eba\u5de5\u547c\u5438\u5668\u696d\u754c\u3067\u3059\u3002\u81f4\u547d\u7684\u306a\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u3001\u73fe\u5728\u3001\u4e16\u754c\u7684\u306b\u4f55\u5343\u53f0\u3082\u306e\u4eba\u5de5\u547c\u5438\u5668\u304c\u4e0d\u8db3\u3057\u3066\u3044\u308b\u3068\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u3068EU\u3067\u306f\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306b\u6025\u5897\u3059\u308bCOVID-19\u60a3\u8005\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u4eba\u5de5\u547c\u5438\u5668\u304c\u307e\u3060\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002 <\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\">\u30dc\u30ea\u30b9\u30fb\u30b8\u30e7\u30f3\u30bd\u30f3\u9996\u76f8\u3068\u30c9\u30ca\u30eb\u30c9\u30fb\u30c8\u30e9\u30f3\u30d7\u5927\u7d71\u9818\u306f\u3001\u81ea\u52d5\u8eca\u7523\u696d\u3001\u822a\u7a7a\u5b87\u5b99\u7523\u696d\u3001\u305d\u306e\u4ed6\u306e\u7523\u696d\u306b\u3001\u3053\u306e\u4e0d\u8db3\u5206\u3092\u88dc\u3046\u3088\u3046\u547c\u3073\u304b\u3051\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u3067\u306f\u30d5\u30a9\u30fc\u30c9\u3001GE\u3001\u30c6\u30b9\u30e9\u306a\u3069\u304c\u7a7a\u8abf\u5de5\u5834\u3067\u547c\u5438\u5668\u3092\u751f\u7523\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u82f1\u56fd\u3067\u306fVentilatorChallengeUK\u30b3\u30f3\u30bd\u30fc\u30b7\u30a2\u30e0\u3092\u8a2d\u7acb\u3057\u30011\u4e07\u500b\u306e\u547c\u5438\u5668\u3092\u751f\u7523\u3057\u3066\u3044\u307e\u3059\u3002\u82f1\u56fd\u306eF1\u30c1\u30fc\u30e07\u793e\u306b\u52a0\u3048\u3001\u30ed\u30fc\u30eb\u30b9\u30fb\u30ed\u30a4\u30b9\u3001\u30a8\u30a2\u30d0\u30b9\u3001\u30a2\u30af\u30bb\u30f3\u30c1\u30e5\u30a2\u3001\u30c7\u30eb\u30fb\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u30ba\u3001\u30b7\u30fc\u30e1\u30f3\u30b9\u3001\u30e6\u30cb\u30ea\u30fc\u30d0\u306a\u3069\u3001\u3055\u307e\u3056\u307e\u306a\u30e1\u30fc\u30ab\u30fc\u304c\u53c2\u52a0\u3057\u3001\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u306e\u30b9\u30df\u30b9\u30fb\u30b0\u30eb\u30fc\u30d7\u3084\u30da\u30f3\u30ed\u30f3\u304c\u4f7f\u7528\u3057\u3066\u3044\u308b\u65e2\u5b58\u306e\u8a2d\u8a08\u306b\u82e5\u5e72\u306e\u5909\u66f4\u3092\u52a0\u3048\u3066\u3001\u4eba\u5de5\u547c\u5438\u5668\u306e\u751f\u7523\u898f\u6a21\u3092\u62e1\u5927\u3057\u3066\u3044\u307e\u3059\u3002\u30d0\u30c3\u30b0\u30ec\u30b9\u6383\u9664\u6a5f\u3084\u30bf\u30c3\u30c1\u30ec\u30b9\u30cf\u30f3\u30c9\u30c9\u30e9\u30a4\u30e4\u30fc\u3092\u958b\u767a\u3057\u305f\u30c0\u30a4\u30bd\u30f3\u306f\u3001\u308f\u305a\u304b10\u65e5\u9593\u3067\u307e\u3063\u305f\u304f\u65b0\u3057\u3044\u30c7\u30b6\u30a4\u30f3\u306e\u4eba\u5de5\u547c\u5438\u5668\u3092\u8a2d\u8a08\u3057\u307e\u3057\u305f\u3002<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u3088\u3046\u306a\u53d6\u308a\u7d44\u307f\u306e\u591a\u304f\u306f\u3001\u65e2\u5b58\u306e\u4eba\u5de5\u547c\u5438\u5668\u306e\u8a2d\u8a08\u3092\u5229\u7528\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u533b\u7642\u6a5f\u5668\u306e\u7d4c\u9a13\u304c\u307b\u3068\u3093\u3069\u306a\u3044\u30e1\u30fc\u30ab\u30fc\u306b\u3068\u3063\u3066\u3001\u898f\u5236\u306f\u91cd\u8981\u306a\u554f\u984c\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u6df1\u304f\u8003\u3048\u3066\u307f\u308b\u3068\u3001\u7c73\u56fd\u3067\u306f\u4eba\u5de5\u547c\u5438\u5668\u306f\u30af\u30e9\u30b9II\u306e\u6a5f\u5668\u306b\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u60a3\u8005\u306e\u5b89\u5168\u6027\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u4e2d\u7a0b\u5ea6\u304b\u3089\u9ad8\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u304a\u308a\u3001\u53b3\u683c\u3067\u9577\u671f\u7684\u306a\u81e8\u5e8a\u8a66\u9a13\u3068\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002FDA\u306b\u306f510(k)\u30dd\u30ea\u30b7\u30fc\u304c\u3042\u308a\u3001\u4eba\u5de5\u547c\u5438\u5668\u3092\u542b\u3080\u3055\u307e\u3056\u307e\u306a\u6a5f\u5668\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u30e1\u30fc\u30ab\u30fc\u304c\u3001\u3059\u3067\u306b\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u88fd\u54c1\u3068\u5b9f\u8cea\u7684\u306b\u985e\u4f3c\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u8a3c\u660e\u3067\u304d\u308c\u3070\u3001\u306f\u308b\u304b\u306b\u5c11\u306a\u3044\u8a66\u9a13\u3067\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u308b\u3068\u3044\u3046\u3082\u306e\u3067\u3059\u3002\u79c1\u81ea\u8eab\u306eFDA\u3068\u306e\u3084\u308a\u3068\u308a\u306e\u7d4c\u9a13\u304b\u3089\u8a00\u3046\u3068\u3001\u4eba\u5de5\u547c\u5438\u5668\u306e\u5834\u5408\u3001\u65b0\u3057\u3044\u3082\u306e\u3067\u306f\u306a\u3044\u306e\u3067\u3001\u5fc5\u305a\u3057\u3082\u5b8c\u5168\u306a\u81e8\u5e8a\u8a66\u9a13\u3092\u884c\u3046\u5fc5\u8981\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3067\u3059\u304b\u3089\u3001COVID-19\u306e\u3088\u3046\u306a\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u72b6\u6cc1\u304c\u306a\u304f\u3066\u3082\u3001\u5fc5\u305a\u3057\u3082\u5927\u898f\u6a21\u306a\u81e8\u5e8a\u8a66\u9a13\u304c\u5fc5\u8981\u306a\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u65b0\u3057\u3044\u4eba\u5de5\u547c\u5438\u5668\u306e\u8a2d\u8a08\u306b\u95a2\u3057\u3066\u3001\u4ee5\u524d\u306e\u4eba\u5de5\u547c\u5438\u5668\u3068\u6bd4\u8f03\u3057\u3066\u4f55\u3089\u304b\u306e\u81e8\u5e8a\u8a55\u4fa1\u3092\u884c\u3044\u3001\u65b0\u3057\u3044\u4eba\u5de5\u547c\u5438\u5668\u3067\u5229\u7528\u3055\u308c\u308b\u81e8\u5e8a\u30c7\u30fc\u30bf\u304c\u540c\u3058\u3067\u3042\u308b\u3068\u4eee\u5b9a\u3067\u304d\u308b\u304b\u3069\u3046\u304b\u3092\u77e5\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u82f1\u56fd\u306e\u898f\u5236\u3067\u306f\u3001\u4eba\u5de5\u547c\u5438\u5668\u306fEU\u3067\u30af\u30e9\u30b92b\u306e\u6a5f\u5668\u3068\u307f\u306a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306f\u3001\u60a3\u8005\u306b\u5bfe\u3059\u308b\u30ea\u30b9\u30af\u304c\u4e2d\u7a0b\u5ea6\u304b\u3089\u9ad8\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u304a\u308a\u3001\u5e83\u7bc4\u306a\u5b89\u5168\u6027\u306e\u30c1\u30a7\u30c3\u30af\u3092\u53d7\u3051\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3057\u304b\u3057\u3001\u4eba\u5de5\u547c\u5438\u5668\u306f\u4f55\u5341\u5e74\u3082\u524d\u304b\u3089\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u305f\u3081\u3001\u65b0\u3057\u3044\u30e2\u30c7\u30eb\u3067\u306f\u3001\u65b0\u3057\u3044\u533b\u7642\u6a5f\u5668\u306e\u9769\u65b0\u306b\u4f34\u30461\u301c2\u5e74\u306e\u898f\u5236\u30d7\u30ed\u30bb\u30b9\u304c\u5fc5\u8981\u306b\u306a\u308b\u3053\u3068\u306f\u307b\u3068\u3093\u3069\u3042\u308a\u307e\u305b\u3093\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA\u306e510(k)\u901a\u77e5\u306f\u300c\u5b9f\u8cea\u7684\u540c\u7b49\u6027\u300d\u306b\u57fa\u3065\u3044\u3066\u3044\u307e\u3059\u304c\u3001EU\u306e510(k)\u901a\u77e5\u306f\u300c\u540c\u7b49\u6027\u306e\u5b9f\u8a3c\u300d\u3068\u547c\u3070\u308c\u3001\u82e5\u5e72\u53b3\u3057\u3044\u3082\u306e\u306e\u3001\u8868\u5411\u304d\u306f\u7c73\u56fd\u306e510(k)\u901a\u77e5\u3068\u540c\u3058\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3084EU\u3060\u3051\u3067\u306a\u304f\u3001\u4e16\u754c\u306e\u898f\u5236\u306e\u72b6\u6cc1\u306f\u73fe\u5728\u3001\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u4f01\u696d\u306b\u3068\u3063\u3066\u6d41\u52d5\u7684\u3067\u3059\u3002\u898f\u5236\u306e\u67a0\u7d44\u307f\u306f\u4e16\u754c\u4e2d\u3067\u5909\u5316\u3057\u3066\u304a\u308a\u3001\u65e2\u5b58\u306e\u898f\u5247\u3082\u9032\u5316\u3057\u3066\u3044\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001\u3053\u308c\u3089\u306e\u307b\u3068\u3093\u3069\u306f\u3001\u6a5f\u5668\u304c\u3069\u3053\u3067\u8ca9\u58f2\u3055\u308c\u3066\u3044\u308b\u304b\u3001\u3069\u306e\u3088\u3046\u306a\u7a2e\u985e\u306e\u6a5f\u5668\u304c\u88fd\u9020\u3055\u308c\u3066\u3044\u308b\u304b\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u3002\u9069\u5207\u306a\u9069\u7528\u9664\u5916\u3092\u6d3b\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u3088\u308a\u8fc5\u901f\u306a\u5e02\u5834\u53c2\u5165\u304c\u53ef\u80fd\u306b\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Impact_of_COVID-19_on_personal_protective_equipment_PPE\"><\/span><b>4.\u500b\u4eba\u7528\u4fdd\u8b77\u5177\uff08PPE\uff09\u306b\u5bfe\u3059\u308bCOVID-19\u306e\u5f71\u97ff<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">COVID 19\u304cPPE\u306b\u4e0e\u3048\u305f\u5f71\u97ff\u306f\u3001\u4f01\u696d\u304c\u304b\u3064\u3066\u306a\u3044\u307b\u3069\u306e\u9700\u8981\u6025\u5897\u306b\u5bfe\u5fdc\u3067\u304d\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u9732\u5448\u3057\u307e\u3057\u305f\u3002WHO\u306e\u885b\u751f\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3084\u3001\u611f\u67d3\u3057\u305f\u60a3\u8005\u306b\u5bfe\u5fdc\u3059\u308b\u533b\u7642\u5f93\u4e8b\u8005\u304b\u3089\u306e\u8981\u6c42\u306b\u5fdc\u3048\u308b\u305f\u3081\u306b\u3001\u9664\u83cc\u5264\u3001\u533b\u7642\u7528\u30de\u30b9\u30af\u3001\u624b\u888b\u3001\u4eba\u5de5\u547c\u5438\u5668\u306a\u3069\u306e\u69d8\u3005\u306aPPE\u304c\u4fdd\u7ba1\u5834\u6240\u306e\u5e95\u3092\u3064\u3044\u3066\u3044\u307e\u3059\u3002PPE\u5e02\u5834\u306b\u304a\u3051\u308b\u3053\u306e\u3088\u3046\u306a\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u6df7\u4e71\u306f\u3001\u91cd\u8981\u306a\u533b\u7642\u90e8\u54c1\u306e\u8f38\u51fa\u5165\u306b\u95a2\u3059\u308b\u653f\u5e9c\u306e\u653f\u7b56\u304c\u786c\u76f4\u5316\u3057\u3066\u3044\u308b\u3053\u3068\u306b\u3088\u308a\u3001\u3055\u3089\u306b\u60aa\u5316\u3057\u3066\u3044\u307e\u3059\u3002COVID 19\u306e\u5f71\u97ff\u3092\u53d7\u3051\u3066\u3001\u8f38\u5165\u95a2\u7a0e\u306e\u5f15\u304d\u4e0a\u3052\u3084\u8f38\u51fa\u898f\u5236\u304c\u3053\u306e\u5e02\u5834\u306e\u4f9b\u7d66\u5371\u6a5f\u306b\u62cd\u8eca\u3092\u304b\u3051\u3066\u3044\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u79c1\u304c\u73fe\u5728\u95a2\u308f\u3063\u3066\u3044\u308b\u7c73\u56fd\u30cb\u30e5\u30fc\u30e8\u30fc\u30af\u306e\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u3067\u306f\u3001PPE\u5e02\u5834\u3092\u6271\u3063\u3066\u3044\u307e\u3059\u304c\u3001\u4e2d\u56fd\u304b\u3089\u8f38\u51fa\u3055\u308c\u308b\u533b\u7642\u90e8\u54c1\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002<\/span> <span style=\"font-weight: 400;\">\u306f\u3001PPE\u306e\u4e16\u754c\u7684\u306a\u4e3b\u8981\u8f38\u51fa\u56fd\u306e\u3072\u3068\u3064\u3067\u3059\u3002\u653f\u5e9c\u306f\u3001\u4e2d\u56fd\u304b\u3089\u8f38\u5165\u3055\u308c\u308b\u4e00\u9023\u306e\u533b\u7642\u88fd\u54c1\u306e\u95a2\u7a0e\u652f\u6255\u3044\u309290\u65e5\u9593\u7336\u4e88\u3059\u308b\u3053\u3068\u3092\u767a\u8868\u3057\u3001\u8f38\u5165\u95a2\u7a0e\u3092\u7de9\u548c\u3059\u308b\u610f\u5411\u3092\u793a\u3057\u307e\u3057\u305f\u304c\u3001\u4e2d\u56fd\u304b\u3089\u8f38\u5165\u3055\u308c\u308b\u3088\u308a\u5e83\u7bc4\u56f2\u306ePPE\u306b\u5bfe\u3059\u308b301\u6761\u95a2\u7a0e\u306e\u64a4\u5ec3\u8981\u8acb\u3092\u62d2\u5426\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u5e02\u5834\u306e\u4f01\u696d\u306f\u8abf\u9054\u4fa1\u683c\u304c\u4e0a\u6607\u3057\u3001\u8f38\u5165\u3092\u63a7\u3048\u308b\u3088\u3046\u306b\u306a\u308b\u3067\u3057\u3087\u3046\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u4fdd\u8b77\u5177\u306e\u9700\u8981\u306e\u6025\u5897\u306b\u5bfe\u5fdc\u3059\u308b\u305f\u3081\u3001\u5927\u591a\u6570\u306e\u56fd\u304cGATT1947\u5354\u5b9a\u306e\u57fa\u672c\u539f\u5247\u306b\u9055\u53cd\u3059\u308b\u5371\u967a\u3092\u5192\u3057\u3001\u533b\u7642\u7528\u90e8\u54c1\u3084\u6a5f\u5668\u306e\u8f38\u51fa\u3092\u5236\u9650\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u3088\u308a\u3001\u533b\u7642\u54c1\u306e\u8f38\u5165\u306b\u5927\u304d\u304f\u4f9d\u5b58\u3057\u3066\u3044\u308b\u56fd\u306ePPE\u5e02\u5834\u3067\u306f\u3001\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306b\u5927\u304d\u306a\u6df7\u4e71\u304c\u751f\u3058\u3066\u3044\u307e\u3059\u3002\u73fe\u5728\u3001EU\u52a0\u76df\u56fd\u306e\u4e00\u90e8\u3067\u8f38\u51fa\u304c\u5236\u9650\u3055\u308c\u3066\u3044\u308b\u4fdd\u8b77\u5177\u306e\u7a2e\u985e\u306b\u306f\u3001\u4fdd\u8b77\u5177\u3068\u547c\u5438\u5668\u304c\u3042\u308a\u307e\u3059\u304c\u3001\u3053\u308c\u306fCOVID-19\u304c\u6587\u660e\u306b\u4e0e\u3048\u305f\u5f71\u97ff\u306e\u4f59\u6ce2\u3068\u8003\u3048\u3089\u308c\u307e\u3059\u3002<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Impact_of_COVID-19_on_medical_device_grant_funding\"><\/span><b>5.COVID-19\u306e\u533b\u7642\u6a5f\u5668\u52a9\u6210\u91d1\u3078\u306e\u5f71\u97ff<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">COVID-19\u3078\u306e\u56fd\u306e\u5bfe\u5fdc\u3092\u5f37\u5316\u3059\u308b\u305f\u3081\u306b\u3001\u4e16\u754c\u4e2d\u306e\u8cc7\u91d1\u63d0\u4f9b\u6a5f\u95a2\u304c\u79d1\u5b66\u7814\u7a76\u30b3\u30df\u30e5\u30cb\u30c6\u30a3\u3084\u4f01\u696d\u3068\u7dca\u5bc6\u306b\u9023\u643a\u3057\u3066\u3044\u307e\u3059\u3002\u7d44\u7e54\u3084\u500b\u4eba\u306f\u3001\u73fe\u5728\u3001\u4ee5\u4e0b\u306b\u5fdc\u52df\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002 <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/grant-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">\u30b0\u30e9\u30f3\u30c8<\/a> COVID-19\u7814\u7a76\u306b\u7279\u5316\u3057\u3066\u3044\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><strong>EU\u306b\u304a\u3051\u308bCOVID-19\u306e\u52a9\u6210\u91d1 <\/strong><\/p>\n<p><span style=\"font-weight: 400;\">\u4f8b\u3048\u3070\u3001EU\u3067\u306f\u3001\u6b27\u5dde\u9023\u5408\u9023\u5e2f\u57fa\u91d1\uff08EUSF\uff09\u306e\u7bc4\u56f2\u304c\u62e1\u5927\u3055\u308c\u3001\u5927\u898f\u6a21\u306a\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u304c\u542b\u307e\u308c\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3057\u305f\u3002\u3053\u306e\u57fa\u91d1\u306f\u3001\u5927\u898f\u6a21\u306a\u81ea\u7136\u707d\u5bb3\u306b\u898b\u821e\u308f\u308c\u305fEU\u52a0\u76df\u56fd\u304a\u3088\u3073\u52a0\u76df\u56fd\u3092\u652f\u63f4\u3059\u308b\u3082\u306e\u3067\u3059\u3002\u4eca\u56de\u306e\u5371\u6a5f\u3092\u53d7\u3051\u3066\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306fEUSF\u306e\u7bc4\u56f2\u3092\u62e1\u5927\u3057\u3001COVID-19\u306b\u3088\u308b\u6df1\u523b\u306a\u88ab\u5bb3\u3092\u53d7\u3051\u305f\u4eba\u3005\u3078\u306e\u8ca1\u653f\u652f\u63f4\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u3092\u63d0\u6848\u3057\u307e\u3057\u305f\u3002\u3057\u305f\u304c\u3063\u3066\u30012020\u5e74\u306b\u306f\u3001\u533b\u7642\u652f\u63f4\u3001\u533b\u7642\u6a5f\u5668\u3001\u5b9f\u9a13\u5ba4\u3067\u306e\u5206\u6790\u3001PPE\u3001\u4f4f\u6c11\u3078\u306e\u7279\u5225\u652f\u63f4\u3001\u5065\u5eb7\u8a3a\u65ad\u3001\u5efa\u7269\u3084\u65bd\u8a2d\u306e\u885b\u751f\u7ba1\u7406\u3001\u30ef\u30af\u30c1\u30f3\u3084\u533b\u85ac\u54c1\u306e\u958b\u767a\u306a\u3069\u306b\u3001\u6700\u59278\u5104\u30e6\u30fc\u30ed\u306e\u8cc7\u91d1\u304c\u5229\u7528\u3067\u304d\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u6b27\u5dde\u59d4\u54e1\u4f1a\u306f\u3001\u533b\u7642\u6a5f\u5668\u306e\u6226\u7565\u7684\u5099\u84c4\u300crescEU\u300d\u3092\u5275\u8a2d\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u5099\u84c4\u54c1\u306b\u306f\u3001COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u72b6\u6cc1\u4e0b\u3067EU\u8af8\u56fd\u3092\u652f\u63f4\u3059\u308b\u305f\u3081\u306e\u4eba\u5de5\u547c\u5438\u5668\u3084\u500b\u4eba\u7528\u4fdd\u8b77\u5177\u306a\u3069\u306e\u6a5f\u5668\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u5099\u84c4\u54c1\u306e\u521d\u671f\u4e88\u7b97\u306f5,000\u4e07\u30e6\u30fc\u30ed\u3067\u3001\u305d\u306e\u3046\u30614,000\u4e07\u30e6\u30fc\u30ed\u306f\u4e88\u7b97\u5f53\u5c40\u306e\u627f\u8a8d\u304c\u5fc5\u8981\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><strong>\u7c73\u56fd\u306b\u304a\u3051\u308bCOVID-19\u306e\u52a9\u6210\u91d1<\/strong><\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u7c73\u56fd\u3067\u306f\u3001\u56fd\u7acb\u79d1\u5b66\u8ca1\u56e3\uff08NSF\uff09\u304cCOVID-19\u306b\u95a2\u3059\u308b\u6570\u5341\u306e\u7814\u7a76\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306b\u8cc7\u91d1\u3092\u63d0\u4f9b\u3057\u3001\u79d1\u5b66\u754c\u3092\u52d5\u54e1\u3057\u3066\u30a6\u30a4\u30eb\u30b9\u306e\u7406\u89e3\u3092\u6df1\u3081\u3001\u5bfe\u5fdc\u7b56\u3092\u958b\u767a\u3057\u3066\u3044\u307e\u3059\u3002NSF\u306eRapid Response Research (RAPID)\u3068\u547c\u3070\u308c\u308b\u8cc7\u91d1\u63d0\u4f9b\u306e\u4ed5\u7d44\u307f\u306b\u3088\u308a\u3001NSF\u306f\u7dca\u6025\u6027\u306e\u9ad8\u3044\u7814\u7a76\u3092\u8fc5\u901f\u306b\u51e6\u7406\u3057\u3001\u652f\u63f4\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u7c73\u56fd\u8b70\u4f1a\u306f\u3001COVID-19\u306e\u7814\u7a76\u3092\u8fc5\u901f\u306b\u9032\u3081\u308b\u305f\u3081\u3001\u56fd\u306e\u8cc7\u91d1\u63f4\u52a9\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u5f37\u5316\u3057\u3066\u3044\u308b\u3002\u8a55\u8ad6\u5bb6\u305f\u3061\u306f\u3001\u653f\u5e9c\u304c\u533b\u7642\u6a5f\u5668\u3084\u6cbb\u7642\u6cd5\u306e\u65b0\u3057\u3044\u7814\u7a76\u306b\u8cc7\u91d1\u3092\u63d0\u4f9b\u3059\u308b\u305f\u3081\u306b\u4f7f\u3046\u304a\u91d1\u306f\u3001COVID-19\u3068\u3044\u3046\u524d\u4f8b\u306e\u306a\u3044\u72b6\u6cc1\u306b\u5bfe\u51e6\u3059\u308b\u305f\u3081\u306b\u8b70\u54e1\u305f\u3061\u304c\u4f5c\u6210\u3057\u305f1\u51462\u5343\u5104\u5186\u306e\u523a\u6fc0\u7b56\u306e\u307b\u3093\u306e\u4e00\u90e8\u306b\u904e\u304e\u306a\u3044\u3068\u4e3b\u5f35\u3057\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u56fd\u7acb\u885b\u751f\u7814\u7a76\u6240\uff08NIH\uff09\u306f\u3001\u7814\u7a76\u8005\u304cCOVID-19\u306b\u7814\u7a76\u52aa\u529b\u3092\u5411\u3051\u308b\u305f\u3081\u306b\u3001\u7af6\u4e89\u529b\u306e\u3042\u308b\u4fee\u6b63\u6848\u3092\u63d0\u51fa\u3057\u305f\u308a\u3001\u65e2\u5b58\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u306e\u88dc\u8db3\u8cc7\u91d1\u3092\u6c42\u3081\u305f\u308a\u3059\u308b\u305f\u3081\u306b\u3001\u3044\u304f\u3064\u304b\u306e\u8cc7\u91d1\u63d0\u4f9b\u6a5f\u4f1a\u306e\u767a\u8868\u3092\u884c\u3044\u307e\u3057\u305f\u3002\u307e\u305f\u3001\u4e00\u822c\u7684\u306b\u5065\u5eb7\u7814\u7a76\u306b\u3042\u307e\u308a\u529b\u3092\u5165\u308c\u3066\u3044\u306a\u3044\u4ed6\u306e\u6a5f\u95a2\u3082\u3001COVID-19\u306e\u305f\u3081\u306b\u533b\u7642\u6a5f\u5668\u958b\u767a\u306e\u7814\u7a76\u958b\u767a\u306e\u512a\u5148\u9806\u4f4d\u3092\u5909\u3048\u3088\u3046\u3068\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n<\/span><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-write-a-winning-grant-proposal-an-expert-guide\/\"><strong>\u307e\u305f\u3001\u4ee5\u4e0b\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002\u6210\u529f\u3059\u308b\u52a9\u6210\u91d1\u63d0\u6848\u66f8\u306e\u66f8\u304d\u65b9\u3002\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30ac\u30a4\u30c9\u00a0<\/strong><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"6_Impact_on_clinical_trials_and_IRB_reviews\"><\/span><b>6.\u81e8\u5e8a\u8a66\u9a13\u3084IRB\u5be9\u67fb\u3078\u306e\u5f71\u97ff<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">COVID-19\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"> \u81e8\u5e8a\u8a66\u9a13<\/a> \u3057\u304b\u3057\u3001\u6e21\u822a\u7981\u6b62\u3001\u75c5\u9662\u3084\u8a3a\u7642\u6240\u3067\u306e\u53d7\u8a3a\u5236\u9650\u3001\u793e\u4f1a\u7684\u306a\u8ddd\u96e2\u3092\u7f6e\u304f\u3053\u3068\u306a\u3069\u306e\u8ab2\u984c\u304c\u3042\u308a\u3001\u3059\u3050\u306b\u306f\u89e3\u6c7a\u3067\u304d\u307e\u305b\u3093\u3067\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u8981\u56e0\u306f\u3001\u4f01\u696d\u306e\u30de\u30a4\u30eb\u30b9\u30c8\u30fc\u30f3\u3001\u4e88\u7b97\u3001\u30c7\u30fc\u30bf\u306e\u6574\u5408\u6027\u306b\u95a2\u9023\u3057\u305f\u8907\u6570\u306e\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3057\u3066\u3044\u307e\u3059\u3002IRB\u306e\u4f1a\u8b70\u3068\u30d7\u30ed\u30bb\u30b9\u306f\u3001\u51fa\u5f35\u306e\u5236\u9650\u306b\u3088\u308b\u5f71\u97ff\u3092\u53d7\u3051\u307e\u305b\u3093\u3002\u6a19\u6e96\u7684\u306b\u306f\u3001IRB\u306f\u30d3\u30c7\u30aa\u4f1a\u8b70\u6280\u8853\u3092\u4f7f\u3063\u3066\u9060\u9694\u5730\u3067\u4f1a\u8b70\u3092\u884c\u3044\u307e\u3059\u3002IRB\u306f\u3001\u53d7\u3051\u53d6\u3063\u305f\u591a\u6570\u306eCOVID-19\u30d7\u30ed\u30c8\u30b3\u30eb\u3084\u3001\u4e0d\u6e2c\u306e\u4e8b\u614b\u306b\u3088\u308b\u7814\u7a76\u884c\u70ba\u306e\u5909\u66f4\u306b\u95a2\u9023\u3059\u308b\u4fee\u6b63\u3092\u512a\u5148\u7684\u306b\u5be9\u67fb\u3057\u3066\u3044\u307e\u3059\u3002<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trial-protocol-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"> \u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb<\/a> \u306f\u3001\u5bfe\u9762\u5f0f\u306e\u8a2a\u554f\u3092\u30d0\u30fc\u30c1\u30e3\u30eb\u8a2a\u554f\u306b\u5909\u66f4\u3059\u308b\u3001\u7814\u7a76\u306e\u5b8c\u5168\u6027\u3084\u53c2\u52a0\u8005\u306e\u5b89\u5168\u6027\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u306a\u3044\u7814\u7a76\u8a2a\u554f\uff0f\u624b\u9806\u306e\u5ec3\u6b62\u3001COVID-19\u66dd\u9732\u306e\u53ef\u80fd\u6027\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306e\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u8cea\u554f\u306e\u5c0e\u5165\u306a\u3069\u3001\u53c2\u52a0\u8005\u3078\u306e\u660e\u767d\u306a\u76f4\u63a5\u7684\u5371\u967a\u6027\u3092\u6392\u9664\u3059\u308b\u305f\u3081\u306b\u5909\u66f4\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u307e\u305f\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u30b9\u30dd\u30f3\u30b5\u30fc\u304c\u76f4\u9762\u3059\u308b\u554f\u984c\u3068\u3057\u3066\u3001\u4ee5\u4e0b\u306e\u3088\u3046\u306a\u3082\u306e\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">\u6cbb\u9a13\u5b9f\u65bd\u65bd\u8a2d\u306e\u9078\u5b9a\uff0f\u958b\u59cb\u306e\u305f\u3081\u306e\u8a2a\u554f\u3001\u304a\u3088\u3073\uff0f\u307e\u305f\u306f\u6cbb\u9a13\u696d\u8005\u306e\u9069\u683c\u6027\u78ba\u8a8d\u306e\u305f\u3081\u306e\u8a2a\u554f\u304c\u3067\u304d\u306a\u3044\u3053\u3068\u306b\u3088\u308b\u6cbb\u9a13\u958b\u59cb\u6d3b\u52d5\u306e\u9045\u5ef6\u3001\u304a\u3088\u3073\u305d\u308c\u306b\u4f34\u3046\u60a3\u8005\u767b\u9332\u306e\u9045\u5ef6\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u6765\u9662\u30b9\u30b1\u30b8\u30e5\u30fc\u30eb\u3001\u8a66\u9a13\u624b\u9806\u3001\u85ac\u5264\u6295\u4e0e\u3001\u304a\u3088\u3073\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u624b\u9806\u3092\u9075\u5b88\u3067\u304d\u306a\u3044\u3053\u3068\u306b\u8d77\u56e0\u3059\u308b\u30d7\u30ed\u30c8\u30b3\u30fc\u30eb\u9075\u5b88\u306e\u554f\u984c\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u88fd\u9020\u30fb\u904b\u55b6\u30b9\u30bf\u30c3\u30d5\u306e\u5236\u9650\u3001\u75c5\u9662\u30b9\u30bf\u30c3\u30d5\u306e\u5236\u9650\u307e\u305f\u306f\u518d\u914d\u7f6e\u3001\u6e21\u822a\u7981\u6b62\u306a\u3069\u306b\u3088\u308b\u3001\u81e8\u5e8a\u6750\u6599\u306e\u6d41\u901a\u3084\u8f38\u51fa\u5165\u306e\u9045\u308c\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u3001\u6cbb\u7642\u3092\u53d7\u3051\u3066\u3044\u308b\u60a3\u8005\u3055\u3093\u304c\u3044\u306a\u3044\u8a66\u9a13\u3001\u65bd\u8a2d\u3001\u307e\u305f\u306f\u7814\u7a76\u306b\u3064\u3044\u3066\u3001\u3059\u3079\u3066\u306e\u60a3\u8005\u3055\u3093\u3078\u306e\u5bfe\u5fdc\u3092\u505c\u6b62\u3059\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/li>\n<li><span style=\"font-weight: 400;\">\u4e3b\u8981\u306a\u79d1\u5b66\u6280\u8853\u4f1a\u8b70\u3084\u5c02\u9580\u5bb6\u4f1a\u8b70\u3001KOL\u3001\u7814\u7a76\u8005\u3001\u79d1\u5b66\u8aee\u554f\u59d4\u54e1\u4f1a\u306e\u4f1a\u8b70\u306e\u4e2d\u6b62\u307e\u305f\u306f\u5ef6\u671f\uff08\u5834\u5408\u306b\u3088\u3063\u3066\u306f\u7121\u671f\u9650\uff09\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">FDA\u306f2020\u5e743\u6708\u306b\u30ac\u30a4\u30c0\u30f3\u30b9\u300cConduct of Clinical Trials of Medicinal Products During COVID-19 Pandemic\u300d\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002<\/span><span style=\"font-weight: 400;\">4<\/span><span style=\"font-weight: 400;\">\u306f\u3001\u8a66\u9a13\u7279\u6709\u306e\u72b6\u6cc1\u306b\u57fa\u3065\u304f\u7de9\u548c\u7b56\u3068\u4e88\u9632\u7b56\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u624b\u9806\u306e\u5909\u66f4\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u4fee\u6b63\u3001\u9038\u8131\u306e\u7ba1\u7406\uff08\u5b9f\u65bd\u3001IRB\u306e\u627f\u8a8d\u3001FDA\u3078\u306e\u76f8\u8ac7\u306a\u3069\uff09\u3084\u3001\u5bfe\u5fdc\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u5831\u544a\u66f8\u306b\u6226\u8853\u3084\u5f71\u97ff\u3092\u8a18\u8f09\u3059\u308b\u305f\u3081\u306e\u6e96\u5099\u306b\u3064\u3044\u3066\u3082\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u63a8\u5968\u4e8b\u9805\u306e\u4e00\u90e8\u306f\u3001Association of Clinical Research Organization (ACRO)\u306eConsiderations to Support Clinical Trial Monitoring Oversight During COVID-19\u3067\u3082\u53d6\u308a\u4e0a\u3052\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/span><span style=\"font-weight: 400;\">5<\/span><span style=\"font-weight: 400;\"> \u307e\u305f\u3001\u82f1\u56fd\u533b\u85ac\u54c1\u30fb\u30d8\u30eb\u30b9\u30b1\u30a2\u88fd\u54c1\u898f\u5236\u5e81\u306e\u300c\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8a66\u9a13\u306e\u7ba1\u7406\u306e\u305f\u3081\u306e\u30a2\u30c9\u30d0\u30a4\u30b9\u300d\u3067\u306f<\/span><span style=\"font-weight: 400;\">6<\/span><span style=\"font-weight: 400;\">.<\/span><\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-write-a-clinical-trial-protocol\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">\u3082\u304a\u8aad\u307f\u304f\u3060\u3055\u3044\u3002\u81e8\u5e8a\u8a66\u9a13\u30d7\u30ed\u30c8\u30b3\u30eb\u306e\u66f8\u304d\u65b9\u3002\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30a2\u30c9\u30d0\u30a4\u30b9\u00a0<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Summary\"><\/span><b>\u6982\u8981<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">\u6700\u5f8c\u306b\u3001\u79c1\u305f\u3061\u306f\u4eca\u3001\u524d\u4f8b\u306e\u306a\u3044\u4e16\u754c\u7684\u306a\u5065\u5eb7\u5371\u6a5f\u306e\u771f\u3063\u53ea\u4e2d\u306b\u3044\u308b\u3053\u3068\u3092\u6539\u3081\u3066\u5f37\u8abf\u3057\u305f\u3044\u3068\u601d\u3044\u307e\u3059\u3002\u3053\u306e\u5371\u6a5f\u306f\u3001\u516c\u8846\u885b\u751f\u306e\u305f\u3081\u306b\u3001\u9867\u5ba2\u3001\u60a3\u8005\u3001\u898f\u5236\u5f53\u5c40\u3001\u516c\u7684\u6a5f\u95a2\u3068\u5bc6\u63a5\u306b\u5354\u529b\u3059\u308b\u3053\u3068\u3092\u533b\u7642\u6a5f\u5668\u696d\u754c\u306b\u6c42\u3081\u3066\u3044\u307e\u3059\u3002\u30cb\u30e5\u30fc\u30b9\u306f\u76ee\u307e\u3050\u308b\u3057\u304f\u5909\u5316\u3057\u3001\u305d\u306e\u591a\u304f\u306f\u5931\u671b\u3001\u30d5\u30e9\u30b9\u30c8\u30ec\u30fc\u30b7\u30e7\u30f3\u3001\u610f\u6c17\u6d88\u6c88\u3059\u308b\u3082\u306e\u3067\u3057\u3087\u3046\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u91cd\u8981\u306a\u306e\u306f\u3001\u30a6\u30a4\u30eb\u30b9\u306e\u8513\u5ef6\u3092\u9632\u304e\u3001\u547d\u3092\u6551\u3046\u305f\u3081\u306b\u3001\u4f01\u696d\u304c\u3069\u306e\u3088\u3046\u306b\u6700\u3082\u52b9\u679c\u7684\u306a\u8ca2\u732e\u304c\u3067\u304d\u308b\u304b\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u77ed\u671f\u7684\u306b\u306f\u3001\u751f\u7523\u91cf\u3092\u65b0\u305f\u306b\u5897\u3084\u3059\u3053\u3068\u3001\u9577\u671f\u7684\u306b\u306f\u3001\u30b9\u30d4\u30fc\u30c9\u304c\u54c1\u8cea\u3092\u7834\u58ca\u3057\u3066\u5c06\u6765\u7684\u306b\u3055\u3089\u306a\u308b\u554f\u984c\u3092\u5f15\u304d\u8d77\u3053\u3059\u3053\u3068\u306e\u306a\u3044\u3088\u3046\u306b\u3001\u898f\u5236\u5f53\u5c40\u306e\u6307\u5c0e\u306b\u5fe0\u5b9f\u3067\u3042\u308b\u3053\u3068\u3001\u306a\u3069\u3067\u3059\u3002\u3044\u305a\u308c\u306b\u3057\u3066\u3082\u3001\u533b\u7642\u6a5f\u5668\u306e\u5c02\u9580\u5bb6\u306f\u3001COVID-19\u3068\u306e\u6226\u3044\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3059\u3053\u3068\u306b\u306a\u308b\u3067\u3057\u3087\u3046\u3002<\/span><\/p>\n<p>&#8212;&#8212;-<\/p>\n<blockquote><p><strong>\u8457\u8005\u306e\u63a1\u7528<\/strong><\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\"><strong><img decoding=\"async\" loading=\"lazy\" class=\"wp-image-7614 alignleft\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-300x300.jpg\" alt=\"\" width=\"215\" height=\"215\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150@2x.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-150x150.jpg 150w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-24x24.jpg 24w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-48x48.jpg 48w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96.jpg 96w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD.jpg 500w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/Shrinidh_JoshiB.PharmM.PhamPhD-96x96@2x.jpg 192w\" sizes=\"(max-width: 215px) 100vw, 215px\" \/><\/strong><\/a>Shrinidh Joshi\u306f\u3001\u88fd\u85ac\u3001\u81e8\u5e8a\u3001\u85ac\u4e8b\u3001\u30e1\u30c7\u30a3\u30ab\u30eb\u30e9\u30a4\u30c6\u30a3\u30f3\u30b0\u306e\u5206\u91ce\u306710\u5e74\u4ee5\u4e0a\u306e\u7d4c\u9a13\u304c\u3042\u308a\u307e\u3059\u3002University Health Network\u3001Krembil Research Institute\u3001Sun Pharma\u3001Virgilant\u3001CannTrust\u3001ThermoFisher Scientific\u306a\u3069\u306e\u4f01\u696d\u3067\u3001\u5b66\u754c\u5185\u5916\u3067\u6d3b\u8e8d\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u5c02\u9580\u5206\u91ce\u306f\u3001\u6297\u4f53\u3001\u518d\u751f\u533b\u7642\u3001\u7d30\u80de\u30fb\u907a\u4f1d\u5b50\u6cbb\u7642\u3001\u30a6\u30a4\u30eb\u30b9\u88fd\u54c1\u3001\u304c\u3093\u514d\u75ab\u7642\u6cd5\u3001\u9593\u8449\u7cfb\u30b9\u30c8\u30ed\u30fc\u30de\u7d30\u80de\u3001\u30d0\u30a4\u30aa\u30ea\u30a2\u30af\u30bf\u30fc\u3001\u533b\u7642\u6a5f\u5668\u3001\u8db3\u5834\u3001\u30ab\u30f3\u30ca\u30d3\u30ce\u30a4\u30c9\u306a\u3069\u306e\u533b\u85ac\u54c1\u30fb\u30d0\u30a4\u30aa\u30ed\u30b8\u30af\u30b9\u5e02\u5834\u3002\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u3001\u30ea\u30b5\u30fc\u30c1\u30da\u30fc\u30d1\u30fc\u3001\u30d6\u30c3\u30af\u30c1\u30e3\u30d7\u30bf\u30fc\u306a\u3069\u3092\u57f7\u7b46\u3057\u3066\u3044\u307e\u3059\u3002<br \/>\n<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=Covid-Meddevices\">\u30b7\u30e5\u30ea\u30cb\u30fc\u30c9\u30fb\u30b8\u30e7\u30b7\u3092\u96c7\u3046<\/a><\/p><\/blockquote>\n<p><b>\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9<\/b><\/p>\n<ol>\n<li><span style=\"font-weight: 400;\">\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u30ea\u30bd\u30fc\u30b9\u30bb\u30f3\u30bf\u30fc\u3002COVID-19\u30de\u30c3\u30d7\u3002Baltimore, MD: Johns Hopkins University; 2020.Available from: https:\/\/coronavirus.jhu.edu\/map.html.\u30a2\u30af\u30bb\u30b9\u306f2020\u5e745\u670817\u65e5<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Carlos del Rio, Preeti N. Malani.COVID-19-New Insights on a Rapidly Changing Epidemic.JAMA.2020;323(14):1339-1340.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Jessop ZM, Dobbs TD, Ali SR, Combellack E, Clancy R, Ibrahim N, Jovic TH, Kaur AJ, Nijran A, O'Neill TB, Whitaker IS.COVID-19\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u6642\u306e\u5916\u79d1\u533b\u306e\u305f\u3081\u306e\u500b\u4eba\u9632\u8b77\u5177\uff08PPE\uff09\u3002A Systematic Review of Availability, Usage, and Rationing.Br J Surg. 2020 May 12.<\/span><\/li>\n<li><span style=\"font-weight: 400;\">COVID-19\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u304a\u3051\u308b\u533b\u7642\u88fd\u54c1\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u306b\u95a2\u3059\u308bFDA\u30ac\u30a4\u30c0\u30f3\u30b9 (<\/span><a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency\"><span style=\"font-weight: 400;\">https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency<\/span><\/a><span style=\"font-weight: 400;\">).<\/span><\/li>\n<li><span style=\"font-weight: 400;\">COVID-19\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8a66\u9a13\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u306e\u76e3\u7763\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306e\u8003\u5bdf\u3002ACRO(<\/span><a href=\"https:\/\/www.acrohealth.org\/wp-content\/uploads\/2020\/03\/ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20.pdf\"><span style=\"font-weight: 400;\">https:\/\/www.acrohealth.org\/wp-content\/uploads\/2020\/03\/ACRO-Statement-on-Monitoring-Oversight-FINAL-3.13.20.pdf<\/span><\/a><span style=\"font-weight: 400;\">)<\/span><\/li>\n<li><span style=\"font-weight: 400;\">MHRA, Advice for Management of Clinical trials in related to Coronavirus.(<\/span><a href=\"https:\/\/mhrainspectorate.blog.gov.uk\/2020\/03\/12\/advice-for-management-of-clinical-trials-in-relation-to-coronavirus\/\"><span style=\"font-weight: 400;\">https:\/\/mhrainspectorate.blog.gov.uk\/2020\/03\/12\/advice-for-management-of-clinical-trials-in-relation-to-coronavirus\/<\/span><\/a><span style=\"font-weight: 400;\">).<\/span><\/li>\n<\/ol>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Kolabtree\u793e\u306e\u30d5\u30ea\u30fc\u30e9\u30f3\u30b9\u30fb\u30ec\u30ae\u30e5\u30e9\u30c8\u30ea\u30fc\u30fb\u30e9\u30a4\u30bf\u30fc\u517c\u81e8\u5e8a\u7814\u7a76\u5c02\u9580\u5bb6\u3067\u3042\u308bShrinidh Joshi\u304c\u3001\u898f\u5236\u5f53\u5c40\u306b\u3088\u308b\u627f\u8a8d\u3001\u81e8\u5e8a\u8a66\u9a13\u3001PPE\u306a\u3069\u3001\u533b\u7642\u6a5f\u5668\u5e02\u5834\u306b\u304a\u3051\u308bcovid-19\u306e\u5f71\u97ff\u306b\u3064\u3044\u3066\u6982\u8aac\u3057\u307e\u3059\u30022020\u5e745\u6708\u521d\u65ec\u306e\u6642\u70b9\u3067\u3001470\u4e07\u4eba\u4ee5\u4e0a\u306e\u4eba\u304cSARS-CoV-2\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306b\u611f\u67d3\u3057\u3066\u3044\u308b\u3053\u3068\u304c\u78ba\u8a8d\u3055\u308c\u3066\u304a\u308a[1]\u3001\u5404\u56fd\u653f\u5e9c\u306f\u305d\u306e\u62e1\u5927\u3092\u6291\u3048\u308b\u305f\u3081\u306b\u8e8d\u8d77\u306b\u306a\u3063\u3066\u3044\u307e\u3059\u3002SARS-CoV-2\u306f\u3001R0\u5024\uff08\u4f1d\u67d3\u529b\u306e\u6307\u6a19\u30012.0\uff5e3.02\u3068\u63a8\u5b9a\uff09\u304c\u9ad8\u3044\u305f\u3081\u3001\u611f\u67d3\u8005\u304c\u5927\u91cf\u306b\u30a6\u30a4\u30eb\u30b9\u3092\u62e1\u6563\u3057\u3001\u7a81\u7136\u3001\u5408\u4f75\u75c7\u3092\u767a\u75c7\u3057\u307e\u3059\u3002\u305d\u306e\u7d50\u679c\u3001\u533b\u7642\u30b7\u30b9\u30c6\u30e0\u306b\u8ca0\u62c5\u304c\u304b\u304b\u308a\u3001\u3059\u3079\u3066\u306e\u60a3\u8005\u306b\u52b9\u679c\u7684\u306b\u533b\u7642\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u304c\u4e16\u754c\u7684\u306a\u8ab2\u984c\u3068\u306a\u3063\u3066\u3044\u308b\u3002\u65e9\u671f\u8b66\u6212\u3078\u306e\u914d\u616e\u304c\u4e0d\u5341\u5206<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/ja\/the-impact-of-covid-19-on-the-medical-device-industry\/\" title=\"\u7d9a\u304d\u3092\u8aad\u3080\">\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/div>","protected":false},"author":12,"featured_media":7618,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[558,540],"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>The covid-19 impact on medical devices market | Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"How COVID-19 impact on medical devices market, including regulatory approvals, Emergency Use Authorizaions (EAUs), grant funding, and more.\" \/>\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\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"The impact of COVID-19 on the medical device industry\" \/>\n<meta property=\"og:description\" content=\"How COVID-19 impact on medical devices market, including regulatory approvals, Emergency Use Authorizaions (EAUs), grant funding, and more.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/ja\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-05-18T16:39:32+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-11-09T08:20:39+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/covid-19-impact-medical-device.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"16\u5206\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"The covid-19 impact on medical devices market | Kolabtree Blog","description":"How COVID-19 impact on medical devices market, including regulatory approvals, Emergency Use Authorizaions (EAUs), grant funding, and more.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.kolabtree.com\/blog\/ja\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/","og_locale":"ja_JP","og_type":"article","og_title":"The impact of COVID-19 on the medical device industry","og_description":"How COVID-19 impact on medical devices market, including regulatory approvals, Emergency Use Authorizaions (EAUs), grant funding, and more.","og_url":"https:\/\/www.kolabtree.com\/blog\/ja\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2020-05-18T16:39:32+00:00","article_modified_time":"2020-11-09T08:20:39+00:00","og_image":[{"width":1280,"height":853,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/05\/covid-19-impact-medical-device.jpg","type":"image\/jpeg"}],"author":"Ramya Sriram","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"\u57f7\u7b46\u8005":"Ramya Sriram","\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593":"16\u5206"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/"},"author":{"name":"Ramya Sriram","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400"},"headline":"The impact of COVID-19 on the medical device industry","datePublished":"2020-05-18T16:39:32+00:00","dateModified":"2020-11-09T08:20:39+00:00","mainEntityOfPage":{"@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/"},"wordCount":3217,"commentCount":0,"publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"articleSection":["COVID-19 resources","Medical Devices"],"inLanguage":"ja","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/","url":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/","name":"The covid-19 impact on medical devices market | Kolabtree Blog","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/#website"},"datePublished":"2020-05-18T16:39:32+00:00","dateModified":"2020-11-09T08:20:39+00:00","description":"How COVID-19 impact on medical devices market, including regulatory approvals, Emergency Use Authorizaions (EAUs), grant funding, and more.","breadcrumb":{"@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/#breadcrumb"},"inLanguage":"ja","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/www.kolabtree.com\/blog\/es\/el-impacto-de-covid-19-en-la-industria-de-los-dispositivos-medicos\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/www.kolabtree.com\/blog\/"},{"@type":"ListItem","position":2,"name":"The impact of COVID-19 on the medical device industry"}]},{"@type":"WebSite","@id":"https:\/\/www.kolabtree.com\/blog\/#website","url":"https:\/\/www.kolabtree.com\/blog\/","name":"The Kolabtree Blog","description":"Expert Views on Science, Innovation and Product Development","publisher":{"@id":"https:\/\/www.kolabtree.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.kolabtree.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"ja"},{"@type":"Organization","@id":"https:\/\/www.kolabtree.com\/blog\/#organization","name":"Kolabtree","url":"https:\/\/www.kolabtree.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Kolabtree"},"image":{"@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/kolabtree","https:\/\/twitter.com\/kolabtree","https:\/\/instagram.com\/kolabtree","https:\/\/www.linkedin.com\/company\/kolabtree","https:\/\/en.m.wikipedia.org\/wiki\/Kolabtree"]},{"@type":"Person","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/81992f5863a1b06d132a47822e7b4400","name":"Ramya Sriram","image":{"@type":"ImageObject","inLanguage":"ja","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/8100b45c960ebbbbe420e8b3f250515f?s=96&d=mm&r=g","caption":"Ramya Sriram"},"description":"Ramya Sriram manages digital content and communications at Kolabtree (kolabtree.com), the world's largest freelancing platform for scientists. She has over a decade of experience in publishing, advertising and digital content creation.","url":"https:\/\/www.kolabtree.com\/blog\/ja\/author\/ramyas\/"}]}},"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7601"}],"collection":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/users\/12"}],"replies":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/comments?post=7601"}],"version-history":[{"count":14,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7601\/revisions"}],"predecessor-version":[{"id":8533,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/posts\/7601\/revisions\/8533"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media\/7618"}],"wp:attachment":[{"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/media?parent=7601"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/categories?post=7601"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.kolabtree.com\/blog\/ja\/wp-json\/wp\/v2\/tags?post=7601"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}