{"id":3274,"date":"2025-10-01T02:14:52","date_gmt":"2025-10-01T02:14:52","guid":{"rendered":"https:\/\/hanheng.easiwin.com\/?p=3274"},"modified":"2025-04-11T02:33:59","modified_gmt":"2025-04-11T02:33:59","slug":"medical-swabs20250729","status":"publish","type":"post","link":"https:\/\/hanheng-medical.com\/ja\/blog\/medical-swabs20250729\/","title":{"rendered":"EU\u3078\u306e\u533b\u7642\u30b9\u30ef\u30d6\u8f38\u5165\u898f\u5236\u306e\u30ca\u30d3\u30b2\u30fc\u30b7\u30e7\u30f3\uff082025\u5e74\uff09"},"content":{"rendered":"<h2 class=\"wp-block-heading\" id=\"1-introduction-why-understanding-eu-import-regulations-for-medical-swabs-matters-in-2025\">1. \u306f\u3058\u3081\u306b\uff1a2025\u5e74\u306bEU\u533b\u7642\u30b9\u30ef\u30d6\u8f38\u5165\u898f\u5236\u3092\u7406\u89e3\u3059\u308b\u91cd\u8981\u6027<\/h2>\n\n\n\n<p>\u6b27\u5dde\u9023\u5408\u304c\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u8a3a\u65ad\u6d88\u8017\u54c1\u306b\u5bfe\u3059\u308b\u898f\u5236\u8981\u4ef6\u3092\u5f37\u5316\u3059\u308b\u4e2d\u3001\u533b\u7642\u30b9\u30ef\u30d6\u306e\u8f38\u5165\u898f\u5236\u3092\u30ca\u30d3\u30b2\u30fc\u30c8\u3059\u308b\u3053\u3068\u306f\u3001B2B\u30d0\u30a4\u30e4\u30fc\u3001\u6d41\u901a\u696d\u8005\u3001\u8abf\u9054\u30de\u30cd\u30fc\u30b8\u30e3\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u306a\u512a\u5148\u4e8b\u9805\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u30022025\u5e74\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306f\u3082\u306f\u3084\u30aa\u30d7\u30b7\u30e7\u30f3\u3067\u306f\u306a\u304f\u3001EU\u52a0\u76df\u56fd\u3067\u306e\u4e8b\u696d\u904b\u55b6\u306b\u5fc5\u9808\u306e\u5074\u9762\u3067\u3059\u3002<\/p>\n\n\n\n<p>\u533b\u7642\u30b9\u30ef\u30d6\u3001\u7279\u306b\u8a3a\u65ad\u691c\u67fb\u7528\uff08\u4f8b\uff1a\u9f3b\u54bd\u982d\u3001\u54bd\u982d\u3001\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\uff09\u306e\u3082\u306e\u306f\u3001EU\u533b\u7642\u6a5f\u5668\u898f\u5236\uff08MDR 2017\/745\uff09\u306e\u3082\u3068\u3067\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5206\u985e\u3055\u308c\u307e\u3059\u3002\u5378\u58f2\u696d\u8005\u3001\u30e9\u30dc\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3001\u75c5\u9662\u8abf\u9054\u62c5\u5f53\u8005\u3067\u3042\u3063\u3066\u3082\u3001\u8f38\u5165\u88fd\u54c1\u304cEU\u57fa\u6e96\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306f\u3001\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u3068\u5408\u6cd5\u7684\u306a\u904b\u55b6\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"importance-of-regulatory-alignment-for-b2b-buyers\">B2B\u30d0\u30a4\u30e4\u30fc\u5411\u3051\u898f\u5236\u9069\u5408\u306e\u91cd\u8981\u6027<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3068\u901a\u95a2\u306e\u9014\u5207\u308c\u306e\u306a\u3044\u78ba\u4fdd<\/li>\n\n\n\n<li>\u30b3\u30b9\u30c8\u306e\u304b\u304b\u308b\u9045\u5ef6\u3001\u7f70\u91d1\u3001\u88fd\u54c1\u30ea\u30b3\u30fc\u30eb\u306e\u9632\u6b62<\/li>\n\n\n\n<li>\u30d8\u30eb\u30b9\u30b1\u30a2\u30d7\u30ed\u30d0\u30a4\u30c0\u30fc\u304a\u3088\u3073\u6a5f\u95a2\u30d0\u30a4\u30e4\u30fc\u3068\u306e\u4fe1\u983c\u69cb\u7bc9<\/li>\n\n\n\n<li>EU\u3067\u306e\u30d6\u30e9\u30f3\u30c9\u4fe1\u983c\u6027\u3068\u4e8b\u696d\u7d99\u7d9a\u6027\u306e\u5411\u4e0a<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"regulatory-priorities-for-2025\">2025\u5e74\u306e\u898f\u5236\u512a\u5148\u4e8b\u9805<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u4e3b\u8981\u9818\u57df<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td>MDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/td><td>\u30af\u30e9\u30b9I-III\u306e\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\uff08\u30b9\u30ef\u30d6\u3092\u542b\u3080\uff09\u304cMDR 2017\/745\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981<\/td><\/tr><tr><td>CE\u30de\u30fc\u30ad\u30f3\u30b0<\/td><td>EU\u5e02\u5834\u30a2\u30af\u30bb\u30b9\u306b\u5fc5\u9808 \u2014 \u9069\u5408\u6027\u8a55\u4fa1\u3092\u793a\u3059<\/td><\/tr><tr><td>UDI\uff08Unique Device Identification\uff09<\/td><td>\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u3068\u5e02\u5834\u5f8c\u76e3\u8996\u306b\u5fc5\u8981<\/td><\/tr><tr><td>EU\u306e\u6b63\u898f\u4ee3\u7406\u4eba<\/td><td>\u975eEU\u30e1\u30fc\u30ab\u30fc\u306f\u898f\u5236\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306b\u4efb\u547d\u5fc5\u9808<\/td><\/tr><tr><td>\u8f38\u5165\u8005\u7fa9\u52d9<\/td><td>\u8f38\u5165\u8005\u306f\u6587\u66f8\u3068\u88fd\u54c1\u9069\u5408\u6027\u3092\u691c\u8a3c\u3059\u308b\u5fc5\u8981<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>EU\u898f\u5236\u74b0\u5883\u306e\u3053\u308c\u3089\u306e\u672c\u8cea\u7684\u306a\u69cb\u6210\u8981\u7d20\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u30012025\u5e74\u306e\u9069\u5408\u6027\u304c\u9ad8\u304f\u53ce\u76ca\u6027\u306e\u9ad8\u3044\u533b\u7642\u30b9\u30ef\u30d6\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u306e\u69cb\u7bc9\u306b\u5411\u3051\u305f\u7b2c\u4e00\u6b69\u3067\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"2-the-current-eu-market-landscape-for-medical-swabs-and-diagnostic-consumables\">2. EU\u306b\u304a\u3051\u308b\u533b\u7642\u30b9\u30ef\u30d6\u304a\u3088\u3073\u8a3a\u65ad\u6d88\u8017\u54c1\u306e\u73fe\u5728\u306e\u5e02\u5834\u72b6\u6cc1<\/h2>\n\n\n\n<p>\u6b27\u5dde\u9023\u5408\u306e\u533b\u7642\u30b9\u30ef\u30d6\u5e02\u5834\u306f\u3001\u611f\u67d3\u75c7\u691c\u67fb\u3001 <a href=\"https:\/\/en.wikipedia.org\/wiki\/Cervical_cancer\" target=\"_blank\" rel=\"noopener\">\u5b50\u5bae\u9838\u304c\u3093<\/a> \u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u65e5\u5e38\u8a3a\u65ad\u306e\u9700\u8981\u5897\u52a0\u306b\u3088\u308a\u9855\u8457\u306a\u6210\u9577\u3092\u9042\u3052\u3066\u3044\u307e\u3059\u3002COVID-19\u4ee5\u964d\u3001\u8a3a\u65ad\u691c\u67fb\u306e\u610f\u8b58\u3068\u30a4\u30f3\u30d5\u30e9\u306f\u5f37\u56fa\u306b\u7dad\u6301\u3055\u308c\u3001\u9ad8\u54c1\u8cea\u30b9\u30ef\u30d6\u304a\u3088\u3073\u95a2\u9023\u6d88\u8017\u54c1\u306e\u7d99\u7d9a\u7684\u306a\u9700\u8981\u3092\u751f\u307f\u51fa\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"market-overview-and-growth-factors\">\u5e02\u5834\u6982\u8981\u3068\u6210\u9577\u8981\u56e0<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30d5\u30a1\u30af\u30bf\u30fc<\/th><th>\u30b9\u30ef\u30d6\u9700\u8981\u3078\u306e\u5f71\u97ff<\/th><\/tr><\/thead><tbody><tr><td>\u65e5\u5e38\u7684\u306aCOVID-19\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0<\/td><td>\u9f3b\u8154\u304a\u3088\u3073\u5589\u30b9\u30ef\u30d6\u306e\u9700\u8981\u3092\u7dad\u6301<\/td><\/tr><tr><td>HPV\u304a\u3088\u3073\u5b50\u5bae\u9838\u304c\u3093\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0<\/td><td>\u5b50\u5bae\u9838\u30d6\u30e9\u30b7\u3068\u30b9\u30af\u30e9\u30d1\u30fc\u306e\u4f7f\u7528\u5897\u52a0<\/td><\/tr><tr><td>\u30dd\u30a4\u30f3\u30c8\u30aa\u30d6\u30b1\u30a2\u691c\u67fb\u306e\u62e1\u5927<\/td><td>\u9ad8\u54c1\u8cea\u3067\u7121\u83cc\u306e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30c4\u30fc\u30eb\u3092\u5fc5\u8981\u3068\u3059\u308b<\/td><\/tr><tr><td>EU\u30d8\u30eb\u30b9\u30b1\u30a2\u306e\u30c7\u30b8\u30bf\u30eb\u5316<\/td><td>\u30c8\u30ec\u30fc\u30b5\u30d6\u30eb\u3067CE\u30de\u30fc\u30af\u4ed8\u304d\u533b\u7642\u6a5f\u5668\u3092\u512a\u9047<\/td><\/tr><tr><td>\u9ad8\u9f62\u5316<\/td><td>\u8a3a\u65ad\u304a\u3088\u3073\u4e88\u9632\u691c\u67fb\u306e\u9700\u8981\u3092\u4fc3\u9032<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"opportunities-for-b2b-buyers-and-distributors\">B2B\u30d0\u30a4\u30e4\u30fc\u3068\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306b\u3068\u3063\u3066\u306e\u30c1\u30e3\u30f3\u30b9<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4fe1\u983c\u3067\u304d\u308b\u4f9b\u7d66\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u6c42\u3081\u308b\u75c5\u9662\u3068\u8a3a\u65ad\u30e9\u30dc<\/li>\n\n\n\n<li>\u8abf\u9054\u306e\u73fe\u5730\u5316\u3092\u76ee\u6307\u3059\u56fd\u6c11\u4fdd\u5065\u30b5\u30fc\u30d3\u30b9<\/li>\n\n\n\n<li>\u898f\u5236\u88fd\u54c1\u3078\u306e\u62e1\u5927\u3092\u9032\u3081\u308be\u30b3\u30de\u30fc\u30b9\u533b\u7642\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0<\/li>\n\n\n\n<li>\u5951\u7d04\u7814\u7a76\u6a5f\u95a2\uff08CRO\uff09\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc<\/li>\n<\/ul>\n\n\n\n<p>\u898f\u5236\u304a\u3088\u3073\u54c1\u8cea\u671f\u5f85\u306b\u6cbf\u3063\u305fB2B\u6d41\u901a\u696d\u8005\u3068e\u30b3\u30de\u30fc\u30b9\u30bb\u30e9\u30fc\u306f\u3001\u9069\u5207\u306a\u8abf\u9054\u6226\u7565\u306b\u3088\u308a\u3001\u53ce\u76ca\u6027\u306e\u9ad8\u3044EU\u30d8\u30eb\u30b9\u30b1\u30a2\u30bb\u30b0\u30e1\u30f3\u30c8\u306b\u53c2\u5165\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"high-demand-swab-types-in-the-eu\">EU\u3067\u306e\u9ad8\u9700\u8981\u30b9\u30ef\u30d6\u30bf\u30a4\u30d7<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u7dbf\u68d2\u30bf\u30a4\u30d7<\/th><th>\u7528\u9014<\/th><th>\u898f\u5236\u30af\u30e9\u30b9<\/th><\/tr><\/thead><tbody><tr><td>\u9f3b\u54bd\u982d\u30b9\u30ef\u30d6<\/td><td>\u547c\u5438\u5668\u30a6\u30a4\u30eb\u30b9\u691c\u51fa<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><tr><td>\u54bd\u982d\u30b9\u30ef\u30d6<\/td><td>COVID-19\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u691c\u67fb<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><tr><td>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30d6\u30e9\u30b7<\/td><td>HPV\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u30d1\u30c3\u30d7\u30b9\u30e1\u30a2<\/td><td>\u30af\u30e9\u30b9IIa<\/td><\/tr><tr><td>\u5a66\u4eba\u79d1\u30b9\u30af\u30ec\u30fc\u30d1\u30fc<\/td><td>\u7d30\u80de\u5b66\u304a\u3088\u3073\u30b5\u30f3\u30d7\u30eb\u63a1\u53d6<\/td><td>\u30af\u30e9\u30b9IIa<\/td><\/tr><tr><td>\u2013 \u81e8\u5e8a\u304a\u3088\u3073\u5fae\u751f\u7269\u5b66\u7684\u7528\u9014\u306b\u6700\u9069<\/td><td>\u8fc5\u901f\u6297\u539f\u30fb\u6297\u4f53\u691c\u67fb<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306f\u73fe\u5728\u3001\u6b27\u5dde\u306e\u8a3a\u65ad\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u306e\u4e0d\u53ef\u6b20\u306a\u30c4\u30fc\u30eb\u3068\u306a\u3063\u3066\u304a\u308a\u3001MDR\u306b\u57fa\u3065\u304f\u5206\u985e\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u3067\u3001\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306f\u9069\u5207\u306a\u696d\u754c\u30bb\u30af\u30bf\u30fc\u3092\u30bf\u30fc\u30b2\u30c3\u30c8\u306b\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-1 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2913\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01.jpg\" alt=\"\" class=\"wp-image-2913\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Nylon-Flocked-SwabOropharyngeal-OP-throat-Specimen-CollectionVarious-Sampling-Site-A-01-01-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2940\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2.jpg\" alt=\"\" class=\"wp-image-2940\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0128-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2936\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2.jpg\" alt=\"\" class=\"wp-image-2936\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-015-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"3-key-eu-regulatory-frameworks-mdr-ce-marking-and-customs-compliance\">3. \u4e3b\u8981\u306aEU\u898f\u5236\u30d5\u30ec\u30fc\u30e0\u30ef\u30fc\u30af\uff1aMDR\u3001CE\u30de\u30fc\u30af\u3001\u30ab\u30b9\u30bf\u30e0\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h2>\n\n\n\n<p>EU\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR 2017\/745\uff09\u306f\u30012021\u5e745\u6708\u306b\u5f93\u6765\u306eMDD\u3092\u5b8c\u5168\u306b\u7f6e\u304d\u63db\u3048\u3001\u73fe\u5728\u306fEU\u306b\u304a\u3051\u308b\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306e\u8f38\u5165\u304a\u3088\u3073\u6d41\u901a\u3092\u7d71\u62ec\u3059\u308b\u4e2d\u5fc3\u7684\u306a\u898f\u5236\u67a0\u7d44\u307f\u3068\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"medical-device-regulation-mdr-2017-745\">\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08MDR 2017\/745\uff09<\/h3>\n\n\n\n<p>MDR\u306f\u3001\u533b\u7642\u7528\u30b9\u30ef\u30d6\u3092\u305d\u306e\u7528\u9014\u306b\u5fdc\u3058\u3066\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u5206\u985e\u3057\u307e\u3059\u3002\u4f8b\u3048\u3070\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u4e00\u822c\u7528\u9014\u306e\u30b9\u30ef\u30d6\u306f\u514d\u9664\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059<\/li>\n\n\n\n<li>\u8a3a\u65ad\u7528\u30b9\u30ef\u30d6\uff08\u9f3b\u8154\u7528\u3001\u5b50\u5bae\u9838\u90e8\u7528\uff09\u306f\u901a\u5e38\u30af\u30e9\u30b9I\u307e\u305f\u306fIIa<\/li>\n\n\n\n<li>\u81ea\u5df1\u63a1\u53d6\u7528\u30b9\u30ef\u30d6\u306b\u306f\u8ffd\u52a0\u8981\u4ef6\u304c\u9069\u7528\u3055\u308c\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"key-mdr-requirements-for-medical-swabs\">\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306b\u95a2\u3059\u308b\u4e3b\u306aMDR\u8981\u4ef6<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30ea\u30b9\u30af\u5206\u985e\uff08\u30af\u30e9\u30b9I\u3001IIa\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u304a\u3088\u3073\u6280\u8853\u6587\u66f8<\/li>\n\n\n\n<li>\u5e02\u8ca9\u5f8c\u76e3\u8996\u8a08\u753b<\/li>\n\n\n\n<li>\u56fa\u6709\u306e\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\uff08UDI\uff09<\/li>\n\n\n\n<li>CE\u30de\u30fc\u30af\u304a\u3088\u3073\u9069\u5408\u5ba3\u8a00<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"ce-marking-for-medical-swabs\">\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306eCE\u30de\u30fc\u30af<\/h3>\n\n\n\n<p>CE\u30de\u30fc\u30af\u306f\u3001\u6b27\u5dde\u7d4c\u6e08\u9818\u57df\uff08EEA\uff09\u5185\u3067\u8ca9\u58f2\u3055\u308c\u308b\u88fd\u54c1\u306b\u5bfe\u3059\u308b\u5fc5\u9808\u306e\u9069\u5408\u30de\u30fc\u30af\u3067\u3059\u3002\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306e\u5834\u5408\u3001\u3053\u308c\u306f\u88fd\u54c1\u304c\u57fa\u672c\u7684\u306a\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u793a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"steps-to-obtain-ce-marking\">CE\u30de\u30fc\u30af\u53d6\u5f97\u306e\u624b\u9806<\/h4>\n\n\n\n<ol class=\"wp-block-list\">\n<li>\u30b9\u30ef\u30d6\u306e\u9069\u5207\u306a\u5206\u985e\u3092\u6c7a\u5b9a\u3059\u308b<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u8a55\u4fa1\u304a\u3088\u3073\u8a66\u9a13\u5831\u544a\u3092\u542b\u3080\u6280\u8853\u30d5\u30a1\u30a4\u30eb\u3092\u4f5c\u6210\u3059\u308b<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09<\/li>\n\n\n\n<li>EU\u8a8d\u5b9a\u4ee3\u8868\u8005\u3092\u4efb\u547d\u3059\u308b\uff08\u88fd\u9020\u696d\u8005\u304cEU\u5916\u306e\u5834\u5408\uff09<\/li>\n\n\n\n<li>\u9069\u5408\u6027\u8a55\u4fa1\u3092\u5b9f\u65bd\u3059\u308b\uff08\u30af\u30e9\u30b9I\u306f\u81ea\u5df1\u8a8d\u8a3c\u3001IIa\u306f\u6307\u5b9a\u6a5f\u95a2\u306b\u3088\u308b\uff09<\/li>\n\n\n\n<li>\u88fd\u54c1\u3092EUDAMED\uff08EU\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff09\u306b\u767b\u9332\u3059\u308b<\/li>\n\n\n\n<li>\u5305\u88c5\u304a\u3088\u3073\u6587\u66f8\u306bCE\u30de\u30fc\u30af\u3092\u660e\u78ba\u306b\u8868\u793a\u3059\u308b<\/li>\n<\/ol>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"customs-and-import-compliance\">\u901a\u95a2\u304a\u3088\u3073\u8f38\u5165\u9075\u5b88<\/h3>\n\n\n\n<p>MDR\u7279\u6709\u306e\u8981\u4ef6\u306b\u52a0\u3048\u3001\u8f38\u5165\u8005\u306fEU\u901a\u95a2\u624b\u7d9a\u304d\u306b\u6e96\u62e0\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u6b63\u78ba\u306a\u901a\u95a2\u5206\u985e\u306e\u305f\u3081\u306eTARIC\u30b3\u30fc\u30c9<\/li>\n\n\n\n<li>\u56fd\u5883\u3067\u306eCE\u9069\u5408\u8a3c\u660e<\/li>\n\n\n\n<li>\u8f38\u5165VAT\u304a\u3088\u3073\u95a2\u7a0e\u7533\u544a<\/li>\n\n\n\n<li>EU\u7d4c\u6e08\u4e8b\u696d\u8005\u767b\u9332\u304a\u3088\u3073\u8b58\u5225\uff08EORI\uff09\u756a\u53f7<\/li>\n\n\n\n<li>\u7a0e\u95a2\u304a\u3088\u3073\u4fdd\u5065\u5f53\u5c40\u3068\u306e\u6587\u66f8\u985e\u306e\u7d71\u4e00<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u8981\u7d20<\/th><th>\u5fc5\u8981\u6761\u4ef6<\/th><th>\u8cac\u4efb\u8005<\/th><\/tr><\/thead><tbody><tr><td>CE\u30de\u30fc\u30ad\u30f3\u30b0<\/td><td>EU\u3067\u306e\u5408\u6cd5\u7684\u306a\u8ca9\u58f2<\/td><td>\u30e1\u30fc\u30ab\u30fc<\/td><\/tr><tr><td>EORI\u756a\u53f7<\/td><td>\u901a\u95a2\u624b\u7d9a\u304d<\/td><td>\u8f38\u5165\u8005<\/td><\/tr><tr><td>\u6280\u8853\u30d5\u30a1\u30a4\u30eb<\/td><td>\u5e02\u5834\u76e3\u8996<\/td><td>\u30e1\u30fc\u30ab\u30fc<\/td><\/tr><tr><td>\u6388\u6a29\u4ee3\u8868\u8005<\/td><td>\u898f\u5236\u95a2\u9023\u306e\u9023\u7d61<\/td><td>EU\u5916\u88fd\u9020\u8005<\/td><\/tr><tr><td>EU\u8a00\u8a9e\u3067\u306e\u30e9\u30d9\u30ea\u30f3\u30b0<\/td><td>\u88fd\u54c1\u30d1\u30c3\u30b1\u30fc\u30b8<\/td><td>\u88fd\u9020\u8005\/\u8f38\u5165\u8005<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u8981\u4ef6\u306e\u3044\u305a\u308c\u304b\u3092\u6e80\u305f\u3055\u306a\u3044\u5834\u5408\u3001\u901a\u95a2\u62d2\u5426\u3001\u7f70\u91d1\u3001\u307e\u305f\u306f\u88fd\u54c1\u62bc\u53ce\u306b\u3064\u306a\u304c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u3001EU\u5411\u3051\u306e\u3059\u3079\u3066\u306e\u51fa\u8377\u306b\u304a\u3044\u3066\u5fb9\u5e95\u3057\u305f\u898f\u5236\u9069\u5408\u304c\u4e0d\u53ef\u6b20\u3068\u306a\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"zKUIMtmxXQ\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/polyurethane-foam-swab-equipement-and-electronic-devices-maintenance-cleaning-longer-and-thicker-plastic-shaft-g-070\/\">\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u30d5\u30a9\u30fc\u30e0\u30b9\u30ef\u30d6\/\u6a5f\u5668\u304a\u3088\u3073\u96fb\u5b50\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\/\u3088\u308a\u9577\u304f\u3001\u3088\u308a\u539a\u3044\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u30b7\u30e3\u30d5\u30c8 G-070<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u201c\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u30d5\u30a9\u30fc\u30e0\u30b9\u30ef\u30d6\/\u6a5f\u5668\u304a\u3088\u3073\u96fb\u5b50\u30c7\u30d0\u30a4\u30b9\u306e\u30e1\u30f3\u30c6\u30ca\u30f3\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\/\u9577\u304f\u3066\u592a\u3044\u30d7\u30e9\u30b9\u30c1\u30c3\u30af\u30b7\u30e3\u30d5\u30c8G-070\u201d \u2014 \u6f22\u6052\u30e1\u30c7\u30a3\u30ab\u30eb\" src=\"https:\/\/hanheng-medical.com\/product\/polyurethane-foam-swab-equipement-and-electronic-devices-maintenance-cleaning-longer-and-thicker-plastic-shaft-g-070\/embed\/#?secret=vaFkSGQ2zO#?secret=zKUIMtmxXQ\" data-secret=\"zKUIMtmxXQ\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"4-top-considerations-when-sourcing-medical-swabs-for-eu-distribution\">4. EU\u6d41\u901a\u5411\u3051\u533b\u7642\u30b9\u30ef\u30d6\u8abf\u9054\u6642\u306e\u4e3b\u306a\u8003\u616e\u4e8b\u9805<\/h2>\n\n\n\n<p>\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306e\u9069\u5207\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u9078\u3076\u3053\u3068\u306f\u3001\u7af6\u4e89\u529b\u306e\u3042\u308b\u4fa1\u683c\u3092\u898b\u3064\u3051\u308b\u4ee5\u4e0a\u306e\u3053\u3068\u3067\u3059\u2014\u5b8c\u5168\u306a\u898f\u5236\u9075\u5b88\u3001\u4e00\u8cab\u3057\u305f\u88fd\u54c1\u54c1\u8cea\u3001\u304a\u3088\u3073\u9577\u671f\u7684\u306a\u4fe1\u983c\u6027\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u3067\u3059\u3002\u3053\u308c\u3089\u306e\u8003\u616e\u4e8b\u9805\u306f\u3001MDR\u304a\u3088\u3073CE\u30de\u30fc\u30af\u9075\u5b88\u304c\u53b3\u683c\u306b\u65bd\u884c\u3055\u308c\u308bEU\u3078\u306e\u8f38\u5165\u6e96\u5099\u306b\u304a\u3044\u3066\u7279\u306b\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"key-factors-eu-distributors-and-buyers-must-evaluate\">EU\u6d41\u901a\u696d\u8005\u304a\u3088\u3073\u30d0\u30a4\u30e4\u30fc\u304c\u8a55\u4fa1\u3059\u3079\u304d\u4e3b\u8981\u8981\u56e0<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8003\u616e\u4e8b\u9805<\/th><th>\u91cd\u8981\u6027<\/th><th>\u5f71\u97ff<\/th><\/tr><\/thead><tbody><tr><td>MDR\u304a\u3088\u3073CE\u9075\u5b88<\/td><td>\u5fc5\u9808<\/td><td>EU\u5e02\u5834\u3078\u306e\u5408\u6cd5\u7684\u306a\u30a2\u30af\u30bb\u30b9\u3092\u78ba\u4fdd<\/td><\/tr><tr><td>\u88fd\u54c1\u54c1\u8cea\u3068\u6ec5\u83cc\u6027<\/td><td>\u9ad8\u3044<\/td><td>\u8a3a\u65ad\u7cbe\u5ea6\u306b\u5f71\u97ff<\/td><\/tr><tr><td>\u75c5\u9662\u304a\u3088\u3073\u516c\u8846\u885b\u751f\u6a5f\u95a2<\/td><td>\u5fc5\u9808<\/td><td>\u6c5a\u67d3\u3092\u9632\u6b62<\/td><\/tr><tr><td>\u8a8d\u8a3c\uff08ISO\u3001FDA\u3001CE\uff09<\/td><td>\u9ad8\u3044<\/td><td>\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u4fe1\u983c\u3092\u691c\u8a3c<\/td><\/tr><tr><td>\u66f8\u985e\u306e\u6e96\u5099\u72b6\u6cc1<\/td><td>\u9ad8\u3044<\/td><td>\u901a\u95a2\u624b\u7d9a\u304d\u306e\u7c21\u7d20\u5316<\/td><\/tr><tr><td>\u4f9b\u7d66\u306e\u30b9\u30b1\u30fc\u30e9\u30d3\u30ea\u30c6\u30a3<\/td><td>\u4e2d<\/td><td>\u6210\u9577\u3059\u308b\u9700\u8981\u3092\u30b5\u30dd\u30fc\u30c8<\/td><\/tr><tr><td>\u88fd\u54c1\u306e\u7a2e\u985e<\/td><td>\u4e2d<\/td><td>\u3088\u308a\u5e45\u5e83\u3044\u30ab\u30bf\u30ed\u30b0\u63d0\u4f9b\u3092\u53ef\u80fd\u306b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"product-quality-and-sterility-standards\">\u30cb\u30e5\u30fc\u30b9\u30ec\u30bf\u30fc\u306b\u3054\u767b\u9332\u304f\u3060\u3055\u3044<\/h3>\n\n\n\n<p>\u8a3a\u65ad\u7528\u9014\u3067\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306f\u3001\u4ea4\u5dee\u6c5a\u67d3\u3084\u7d50\u679c\u306e\u59a5\u5354\u3092\u9632\u3050\u305f\u3081\u3001\u5236\u5fa1\u3055\u308c\u305f\u74b0\u5883\u3067\u88fd\u9020\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u691c\u7d22\u5bfe\u8c61:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30e9\u30b9100,000\uff08ISO 8\uff09\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u8a8d\u8a3c<\/li>\n\n\n\n<li>EO\u6ec5\u83cc\u65b9\u6cd5<\/li>\n\n\n\n<li>\u4fdd\u5b58\u671f\u9593\u691c\u8a3c\u8a66\u9a13<\/li>\n\n\n\n<li>\u751f\u4f53\u9069\u5408\u6027\u304a\u3088\u3073\u7d30\u80de\u6bd2\u6027\u8a66\u9a13<\/li>\n\n\n\n<li>\u30ed\u30c3\u30c8\u8ffd\u8de1\u6027\u3068\u30d0\u30c3\u30c1\u7ba1\u7406<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"supplier-documentation-package-for-eu-import\">EU\u8f38\u5165\u306e\u305f\u3081\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u66f8\u985e\u30d1\u30c3\u30b1\u30fc\u30b8<\/h3>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u51fa\u8377\u306b\u306f\u3001MDR\u304a\u3088\u3073\u901a\u95a2\u9075\u5b88\u3092\u6e80\u305f\u3059\u66f8\u985e\u30d0\u30f3\u30c9\u30eb\u3092\u542b\u3081\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9069\u5408\u5ba3\u8a00\uff08DoC\uff09<\/li>\n\n\n\n<li>CE\u8a3c\u660e\u66f8\uff08\u30af\u30e9\u30b9IIa\u4ee5\u4e0a\u306e\u5834\u5408\uff09<\/li>\n\n\n\n<li>ISO13485\u8a3c\u660e\u66f8<\/li>\n\n\n\n<li>\u6ec5\u83cc\u30ec\u30dd\u30fc\u30c8<\/li>\n\n\n\n<li>EU\u8a00\u8a9e\u306b\u3088\u308b\u4f7f\u7528\u8aac\u660e\u66f8\uff08IFU\uff09<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\uff08\u5f53\u5c40\u304b\u3089\u8981\u6c42\u3055\u308c\u305f\u5834\u5408\uff09<\/li>\n\n\n\n<li>UDI\uff08\u30e6\u30cb\u30fc\u30af\u30c7\u30d0\u30a4\u30b9\u8b58\u5225\u5b50\uff09<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"questions-to-ask-your-supplier\">\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u306b\u5c0b\u306d\u308b\u3079\u304d\u8cea\u554f<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>MDR 2017\/745\u306b\u6e96\u62e0\u3057\u305fCE\u30de\u30fc\u30af\u4ed8\u304d\u30b9\u30ef\u30d6\u3092\u304a\u6301\u3061\u3067\u3059\u304b\uff1f<\/li>\n\n\n\n<li>\u901a\u95a2\u306e\u305f\u3081\u306e\u5b8c\u5168\u306a\u6280\u8853\u6587\u66f8\u3092\u63d0\u4f9b\u3067\u304d\u307e\u3059\u304b\uff1f<\/li>\n\n\n\n<li>\u3069\u306e\u3088\u3046\u306a\u6ec5\u83cc\u30d7\u30ed\u30bb\u30b9\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n\n\n\n<li>\u65bd\u8a2d\u306fISO13485\u8a8d\u8a3c\u3092\u53d6\u5f97\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n\n\n\n<li>EU\u5e02\u5834\u5411\u3051\u306e\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30e9\u30d9\u30eb\u307e\u305f\u306fOEM\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u307e\u3059\u304b\uff1f<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u30d1\u30e9\u30e1\u30fc\u30bf\u3067\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u8a55\u4fa1\u3059\u308b\u3053\u3068\u3067\u3001EU\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u304a\u3088\u3073B2B\u30d0\u30a4\u30e4\u30fc\u306f\u898f\u5236\u30ea\u30b9\u30af\u3092\u6700\u5c0f\u9650\u306b\u6291\u3048\u3001\u3088\u308a\u5f37\u976d\u306a\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u69cb\u7bc9\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"5-trusted-global-medical-swab-manufacturers-why-hanheng-leads-from-china\">5. \u4fe1\u983c\u3067\u304d\u308b\u30b0\u30ed\u30fc\u30d0\u30eb\u533b\u7642\u7528\u30b9\u30ef\u30d6\u30e1\u30fc\u30ab\u30fc \u2013 \u4e2d\u56fd\u306eHanheng\u304c\u30ea\u30fc\u30c9\u3059\u308b\u7406\u7531<\/h2>\n\n\n\n<p>\u591a\u304f\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30e1\u30fc\u30ab\u30fc\u304c\u533b\u7642\u7528\u30b9\u30ef\u30d6\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u6b27\u5dde\u5e02\u5834\u306e\u5305\u62ec\u7684\u306a\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3001\u54c1\u8cea\u3001\u30b9\u30b1\u30fc\u30e9\u30d3\u30ea\u30c6\u30a3\u306e\u30cb\u30fc\u30ba\u3092\u6e80\u305f\u3059\u3082\u306e\u306f\u307b\u3068\u3093\u3069\u3042\u308a\u307e\u305b\u3093\u3002EU\u91cd\u8996\u306e\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001 <a href=\"https:\/\/hanheng-medical.com\/ja\/about-us\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853\u6709\u9650\u516c\u53f8 <\/a>\u9ad8\u54c1\u8cea\u3067EU\u6e96\u62e0\u306e\u533b\u7642\u691c\u67fb\u6d88\u8017\u54c1\u306e\u30d7\u30ec\u30df\u30a2\u4e2d\u56fd\u30e1\u30fc\u30ab\u30fc\u3068\u3057\u3066\u969b\u7acb\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"why-hanheng-is-the-leading-medical-swab-manufacturer-in-china\">Hanheng\u304c\u4e2d\u56fd\u306e\u30ea\u30fc\u30c7\u30a3\u30f3\u30b0\u533b\u7642\u7528\u30b9\u30ef\u30d6\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308b\u7406\u7531<\/h3>\n\n\n\n<p>2018\u5e74\u306b\u8a2d\u7acb\u3055\u308c\u305fJiangsu Hanheng\u306f\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u5411\u3051\u306e\u8a3a\u65ad\u533b\u7642\u6d88\u8017\u54c1\u306e\u7814\u7a76\u958b\u767a\u3068\u88fd\u9020\u3092\u5c02\u9580\u3068\u3057\u3066\u3044\u307e\u3059\u300210,000\u33a1\u306eISO\u30af\u30e9\u30b9100,000\u30af\u30ea\u30fc\u30f3\u30eb\u30fc\u30e0\u306832\u30a8\u30fc\u30ab\u30fc\u306e\u88fd\u9020\u30ad\u30e3\u30f3\u30d1\u30b9\u3092\u5099\u3048\u3001Hanheng\u306fEU\u8f38\u5165\u8981\u4ef6\u3092\u6e80\u305f\u3059\u5927\u898f\u6a21\u3067\u7121\u83cc\u7684\u306a\u751f\u7523\u306b\u6700\u9069\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"hanheng-product-range-for-eu-markets\">EU\u5e02\u5834\u5411\u3051Hanheng\u88fd\u54c1\u30e9\u30a4\u30f3\u30ca\u30c3\u30d7<\/h4>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u88fd\u54c1<\/th><th>\u30e1\u30c7\u30a3\u30ab\u30eb\u30fb\u30a2\u30d7\u30ea\u30b1\u30fc\u30b7\u30e7\u30f3<\/th><th>CE\u30de\u30fc\u30af\u4ed8\u304d<\/th><th>MDR\u30af\u30e9\u30b9<\/th><\/tr><\/thead><tbody><tr><td>\u9f3b\u8154\u30b9\u30ef\u30d6<\/td><td>COVID-19\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3001RSV\u691c\u67fb<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><tr><td>\u54bd\u982d\u30b9\u30ef\u30d6<\/td><td>\u547c\u5438\u5668\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><tr><td>\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7<\/td><td>HPV\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0\u3001\u7d30\u80de\u5b66<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9IIa<\/td><\/tr><tr><td>\u5a66\u4eba\u79d1\u30b9\u30af\u30ec\u30fc\u30d1\u30fc<\/td><td>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u63a1\u53d6<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9IIa<\/td><\/tr><tr><td>\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/td><td>\u5b50\u5bae\u9838\u90e8\u7d30\u80de\u8a3a\u3001HPV<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9IIa<\/td><\/tr><tr><td>\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u30dc\u30c3\u30af\u30b9<\/td><td>\u8f38\u9001\u304a\u3088\u3073\u4fdd\u5b58<\/td><td>\u2714\ufe0f<\/td><td>\u30af\u30e9\u30b9I<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3059\u3079\u3066\u306e\u88fd\u54c1\u306fISO9001\u304a\u3088\u3073ISO13485\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0\u306e\u4e0b\u3067\u88fd\u9020\u3055\u308c\u3066\u304a\u308a\u3001Hanheng\u306e\u30dd\u30fc\u30c8\u30d5\u30a9\u30ea\u30aa\u306b\u306fCE\u30de\u30fc\u30af\u4ed8\u304d\u304a\u3088\u3073FDA\u627f\u8a8d\u6e08\u307f\u306e\u30a2\u30a4\u30c6\u30e0\u304c\u542b\u307e\u308c\u3066\u304a\u308a\u3001EU\u304a\u3088\u3073\u30b0\u30ed\u30fc\u30d0\u30eb\u5e02\u5834\u3068\u306e\u4e92\u63db\u6027\u3092\u78ba\u4fdd\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"what-sets-hanheng-apart-for-eu-distributors\">EU\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306b\u3068\u3063\u3066Hanheng\u306e\u512a\u4f4d\u6027<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5b8c\u5168\u306aMDR\u304a\u3088\u3073CE\u6587\u66f8\u30b5\u30dd\u30fc\u30c8<\/li>\n\n\n\n<li>EU\u30d0\u30a4\u30e4\u30fc\u5411\u3051\u306e\u30ab\u30b9\u30bf\u30e0\u30e9\u30d9\u30ea\u30f3\u30b0\u304a\u3088\u3073OEM\u30b5\u30fc\u30d3\u30b9<\/li>\n\n\n\n<li>\u30b0\u30ed\u30fc\u30d0\u30eb\u30ed\u30b8\u30b9\u30c6\u30a3\u30af\u30b9\u80fd\u529b\u306b\u3088\u308b\u8fc5\u901f\u306a\u30ea\u30fc\u30c9\u30bf\u30a4\u30e0<\/li>\n\n\n\n<li>\u7121\u83cc\u4fdd\u8a3c\u3068\u9ad8\u3044\u30b5\u30f3\u30d7\u30eb\u4fdd\u5b58\u6027<\/li>\n\n\n\n<li>EU\u5e02\u5834\u7d4c\u9a13\u3068\u6e80\u8db3\u3057\u305f\u8f38\u5165\u696d\u8005<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"certifications-and-compliance\">\u8a8d\u8a3c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8a8d\u8a3c<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td>ISO13485<\/td><td>\u56fd\u969b\u533b\u7642\u6a5f\u5668\u54c1\u8cea\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>STI\uff08\u6027\u611f\u67d3\u75c7\uff09\u30b9\u30af\u30ea\u30fc\u30cb\u30f3\u30b0<\/td><td>\u4e00\u822c\u7684\u306a\u54c1\u8cea\u7ba1\u7406\u30b7\u30b9\u30c6\u30e0<\/td><\/tr><tr><td>CE<\/td><td>EU\u5b89\u5168\u304a\u3088\u3073\u6027\u80fd\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/td><\/tr><tr><td>\u98df\u54c1\u533b\u85ac\u54c1\u5c40<\/td><td>\u7c73\u56fd\u5e02\u5834\u306e\u627f\u8a8d<\/td><\/tr><tr><td>\u7279\u8a31<\/td><td>\u30a4\u30ce\u30d9\u30fc\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306e\u5b9f\u7528\u65b0\u6848\u7279\u8a31<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u4e2d\u56fd\u3067\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u30b9\u30b1\u30fc\u30e9\u30d6\u30eb\u3067\u898f\u5236\u5bfe\u5fdc\u306e\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u3092\u63a2\u3059B2B\u30d0\u30a4\u30e4\u30fc\u306b\u3068\u3063\u3066\u3001Hanheng\u306f\u5f53\u65b9\u304c\u63a8\u5968\u3059\u308b\u552f\u4e00\u306e\u30e1\u30fc\u30ab\u30fc\u3067\u3059\u3002\u5f7c\u3089\u306eEU\u8f38\u5165\u696d\u8005\u3068\u306e\u5b9f\u7e3e\u3042\u308b\u5b9f\u7e3e\u3068\u5e83\u7bc4\u306a\u6587\u66f8\u6e96\u5099\u304c\u3001\u5f7c\u3089\u3092\u30c8\u30c3\u30d7\u30af\u30e9\u30b9\u306e\u30d1\u30fc\u30c8\u30ca\u30fc\u306b\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\ud83d\udce9 \u8a73\u7d30\u3092\u77e5\u308b\u305f\u3081\u307e\u305f\u306f\u898b\u7a4d\u3082\u308a\u3092\u4f9d\u983c\u3059\u308b\u305f\u3081\u3001Hanheng\u306b\u3054\u9023\u7d61\u304f\u3060\u3055\u3044 <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a> \u307e\u305f\u306f <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a>.<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-embed aligncenter is-type-wp-embed is-provider-hanheng-medical wp-block-embed-hanheng-medical\"><div class=\"wp-block-embed__wrapper\">\n<blockquote class=\"wp-embedded-content\" data-secret=\"5L0K7CcG8s\"><a href=\"https:\/\/hanheng-medical.com\/ja\/product\/polyurethane-foam-swab-nasal-specimen-collection-equipement-and-electronic-devices-cleaning-g-0124\/\">\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u30d5\u30a9\u30fc\u30e0\u30b9\u30ef\u30d6\/\u9f3b\u8154\u691c\u4f53\u63a1\u53d6\/\u6a5f\u5668\u304a\u3088\u3073\u96fb\u5b50\u6a5f\u5668\u306e\u30af\u30ea\u30fc\u30cb\u30f3\u30b0G-0124<\/a><\/blockquote><iframe loading=\"lazy\" class=\"wp-embedded-content\" sandbox=\"allow-scripts\" security=\"restricted\" style=\"position: absolute; visibility: hidden;\" title=\"\u300c\u30dd\u30ea\u30a6\u30ec\u30bf\u30f3\u30d5\u30a9\u30fc\u30e0\u30b9\u30ef\u30d6\/\u9f3b\u8154\u691c\u4f53\u63a1\u53d6\/\u6a5f\u5668\u304a\u3088\u3073\u96fb\u5b50\u6a5f\u5668\u306e\u30af\u30ea\u30fc\u30cb\u30f3\u30b0G-0124\u300d\u2014 Hanheng Medical\" src=\"https:\/\/hanheng-medical.com\/product\/polyurethane-foam-swab-nasal-specimen-collection-equipement-and-electronic-devices-cleaning-g-0124\/embed\/#?secret=x7G4AbEOT2#?secret=5L0K7CcG8s\" data-secret=\"5L0K7CcG8s\" width=\"600\" height=\"338\" frameborder=\"0\" marginwidth=\"0\" marginheight=\"0\" scrolling=\"no\"><\/iframe>\n<\/div><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"6-the-role-of-authorized-representatives-and-importers-in-eu-medical-device-compliance\">6. EU\u533b\u7642\u6a5f\u5668\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306b\u304a\u3051\u308b\u8a8d\u5b9a\u4ee3\u8868\u8005\u3068\u8f38\u5165\u8005\u306e\u5f79\u5272<\/h2>\n\n\n\n<p>EU\u5916\u306e\u30e1\u30fc\u30ab\u30fc\u3067\u3042\u308bHanheng\u306e\u5834\u5408\u3001MDR 2017\/745\u306e\u4e0b\u3067EU\u8a8d\u5b9a\u4ee3\u8868\u8005\uff08EU AR\uff09\u304a\u3088\u3073\u6307\u5b9a\u8f38\u5165\u696d\u8005\u3068\u5354\u529b\u3059\u308b\u3053\u3068\u304c\u7fa9\u52d9\u4ed8\u3051\u3089\u308c\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u5f79\u5272\u306e\u8cac\u4efb\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001EU\u3067\u4e8b\u696d\u3092\u884c\u3046\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u3001\u5378\u58f2\u696d\u8005\u3001e\u30b3\u30de\u30fc\u30b9\u30bb\u30e9\u30fc\u306b\u3068\u3063\u3066\u91cd\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"eu-authorized-representative-eu-ar\">EU\u8a8d\u5b9a\u4ee3\u8868\u8005\uff08EU AR\uff09<\/h3>\n\n\n\n<p>EU AR\u306f\u3001EU\u57df\u5185\u306b\u62e0\u70b9\u3092\u7f6e\u304f\u6cd5\u4eba\u3067\u3001\u975eEU\u30e1\u30fc\u30ab\u30fc\u306e\u4ee3\u308f\u308a\u306b\u898f\u5236\u4e8b\u9805\u3092\u6271\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"responsibilities-of-the-eu-ar\">EU AR \u306e\u8cac\u4efb<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5e02\u5834\u6295\u5165\u524d\u306b\u6a5f\u5668\u306e\u9069\u5408\u6027\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\u306e\u5199\u3057\u3092\u4fdd\u7ba1\u3059\u308b<\/li>\n\n\n\n<li>\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3084\u76e3\u67fb\u304c\u767a\u751f\u3057\u305f\u5834\u5408\u306b EU \u5f53\u5c40\u3068\u5354\u529b\u3059\u308b<\/li>\n\n\n\n<li>\u88fd\u54c1\u3092 EUDAMED \u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\u306b\u767b\u9332\u3059\u308b<\/li>\n\n\n\n<li>\u30e9\u30d9\u30eb\u4ed8\u3051\u3068\u6307\u793a\u4e8b\u9805\u304c EU \u8a00\u8a9e\u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u8981\u4ef6<\/th><th>\u8aac\u660e<\/th><\/tr><\/thead><tbody><tr><td>\u6cd5\u7684\u6240\u5728\u5730<\/td><td>EU \u52a0\u76df\u56fd\u306b\u62e0\u70b9\u3092\u7f6e\u304f\u5fc5\u8981\u304c\u3042\u308b<\/td><\/tr><tr><td>\u767b\u9332<\/td><td>\u88fd\u54c1\u30e9\u30d9\u30eb\u306b\u8a18\u8f09\u3055\u308c\u308b\u5fc5\u8981\u304c\u3042\u308b<\/td><\/tr><tr><td>\u30c9\u30ad\u30e5\u30e1\u30f3\u30c6\u30fc\u30b7\u30e7\u30f3<\/td><td>\u88fd\u9020\u8005\u306e\u6280\u8853\u6587\u66f8\u3092\u4fdd\u7ba1\u3059\u308b<\/td><\/tr><tr><td>\u8cac\u4efb<\/td><td>\u88fd\u9020\u8005\u3068\u6cd5\u7684\u8cac\u4efb\u3092\u5171\u6709\u3059\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"importer-role-under-mdr\">MDR \u306b\u304a\u3051\u308b\u8f38\u5165\u696d\u8005\u306e\u5f79\u5272<\/h3>\n\n\n\n<p>\u8f38\u5165\u696d\u8005\u306f\u3001EU \u5185\u3067\u88fd\u54c1\u3092 EU \u5e02\u5834\u306b\u6700\u521d\u306b\u6295\u5165\u3059\u308b\u4e8b\u696d\u8005\u3067\u3059\u3002\u3053\u306e\u5f53\u4e8b\u8005\u306f\u3001\u9069\u5408\u6027\u306e\u78ba\u4fdd\u306b\u304a\u3044\u3066\u91cd\u8981\u306a\u5f79\u5272\u3092\u679c\u305f\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" id=\"importer-responsibilities\">\u8f38\u5165\u8005\u306e\u8cac\u4efb<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u8f38\u5165\u524d\u306b CE \u30de\u30fc\u30af\u3068 EU DoC \u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u88fd\u9020\u8005\u304c EU AR \u3092\u6307\u5b9a\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n\n\n\n<li>\u82e6\u60c5\u3068\u4e0d\u9069\u5408\u306e\u8a18\u9332\u7c3f\u3092\u7dad\u6301\u3059\u308b<\/li>\n\n\n\n<li>\u91cd\u5927\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3092\u88fd\u9020\u8005\u3068 AR \u306b\u5831\u544a\u3059\u308b<\/li>\n\n\n\n<li>UDI \u304c\u8cbc\u4ed8\u3055\u308c\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30bf\u30b9\u30af<\/th><th>\u8f38\u5165\u696d\u8005\u306f\u2026<\/th><\/tr><\/thead><tbody><tr><td>\u30e9\u30d9\u30eb\u78ba\u8a8d<\/td><td>\u30e9\u30d9\u30eb\u304c MDR \u8981\u4ef6\u3092\u6e80\u305f\u3059\u3053\u3068\u3092\u78ba\u4fdd\u3059\u308b<\/td><\/tr><tr><td>CE \u78ba\u8a8d<\/td><td>\u88fd\u54c1\u306b\u6709\u52b9\u306a CE \u30de\u30fc\u30af\u304c\u3042\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/td><\/tr><tr><td>\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u5831\u544a<\/td><td>AR \u3068\u4e3b\u7ba1\u5f53\u5c40\u306b\u901a\u77e5\u3059\u308b<\/td><\/tr><tr><td>\u8a18\u9332\u4fdd\u6301<\/td><td>10 \u5e74\u9593\u306e\u76e3\u67fb\u30c8\u30ec\u30a4\u30eb\u3092\u7dad\u6301\u3059\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"choosing-reliable-partners\">\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u306e\u9078\u629e<\/h3>\n\n\n\n<p>B2B \u30d0\u30a4\u30e4\u30fc\u304a\u3088\u3073\u6d41\u901a\u696d\u8005\u5411\u3051\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU AR \u304a\u3088\u3073\u8f38\u5165\u696d\u8005\u306e\u30d7\u30ed\u30c8\u30b3\u30eb\u3092\u7406\u89e3\u3057\u3066\u3044\u308b Hanheng \u306e\u3088\u3046\u306a\u88fd\u9020\u8005\u3068\u5354\u529b\u3059\u308b<\/li>\n\n\n\n<li>\u7269\u6d41\u30d1\u30fc\u30c8\u30ca\u30fc\u304cMDR\u8f38\u5165\u66f8\u985e\u306b\u7cbe\u901a\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n\n\n\n<li>AR\u3068\u8f38\u5165\u3092\u4e00\u62ec\u3067\u6271\u3046\u30d5\u30eb\u30b5\u30fc\u30d3\u30b9\u8f38\u5165\u4ee3\u7406\u5e97\u3068\u306e\u9023\u643a\u3092\u691c\u8a0e\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udcbc \u30d7\u30ed\u306e\u30d2\u30f3\u30c8\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\">\u6f22\u6052<\/a> \u306f\u3001\u5b8c\u5168\u306aMDR\u66f8\u985e\u3092\u6e96\u5099\u3059\u308b\u3053\u3068\u3067\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3001\u533b\u7642\u6d88\u8017\u54c1\u306e\u53d6\u308a\u6271\u3044\u306b\u7d4c\u9a13\u8c4a\u5bcc\u306aEU AR\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u63a8\u85a6\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u5f79\u5272\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u5358\u306a\u308b\u898f\u5236\u9075\u5b88\u306b\u3068\u3069\u307e\u3089\u305a\u3001\u6226\u7565\u7684\u306a\u610f\u5473\u3092\u6301\u3061\u307e\u3059\u3002\u6e96\u62e0\u3057\u305f\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u9078\u3076\u3053\u3068\u3067\u3001\u901a\u95a2\u306e\u8fc5\u901f\u5316\u3001\u5e02\u5834\u5f8c\u554f\u984c\u306e\u6e1b\u5c11\u3001EU\u5e02\u5834\u3078\u306e\u30b9\u30e0\u30fc\u30ba\u306a\u62e1\u5927\u304c\u5b9f\u73fe\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"7-how-to-successfully-import-medical-swabs-into-the-eu-step-by-step-guide-for-distributors\">7. EU\u3078\u306e\u533b\u7642\u30b9\u30ef\u30d6\u8f38\u5165\u6210\u529f\u306e\u305f\u3081\u306e\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7\u30ac\u30a4\u30c9\uff1a\u6d41\u901a\u696d\u8005\u5411\u3051<\/h2>\n\n\n\n<p>B2B\u30d0\u30a4\u30e4\u30fc\u3001\u8f38\u5165\u696d\u8005\u3001\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306b\u3068\u3063\u3066\u3001\u533b\u7642\u7528\u30b9\u30ef\u30d6\u3092\u6b27\u5dde\u9023\u5408\u306b\u8f38\u5165\u3059\u308b\u30a8\u30f3\u30c9\u30c4\u30fc\u30a8\u30f3\u30c9\u306e\u30d7\u30ed\u30bb\u30b9\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u78ba\u4fdd\u3057\u3001\u898f\u5236\u3084\u901a\u95a2\u306b\u95a2\u3059\u308b\u9ad8\u984d\u306a\u554f\u984c\u3092\u56de\u907f\u3059\u308b\u305f\u3081\u306b\u4e0d\u53ef\u6b20\u3067\u3059\u3002\u4ee5\u4e0b\u306e\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7\u306e\u89e3\u8aac\u306f\u30012025\u5e74\u306bMDR 2017\/745\u306e\u4e0b\u3067\u6210\u529f\u88cf\u306b\u8f38\u5165\u3059\u308b\u305f\u3081\u306e\u5fc5\u8981\u306a\u3059\u3079\u3066\u3092\u30ab\u30d0\u30fc\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"step-by-step-import-process-for-medical-swabs-into-the-eu\">EU\u3078\u306e\u533b\u7642\u7528\u30b9\u30ef\u30d6\u8f38\u5165\u30d7\u30ed\u30bb\u30b9\u306e\u30b9\u30c6\u30c3\u30d7\u30d0\u30a4\u30b9\u30c6\u30c3\u30d7<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u30b9\u30c6\u30c3\u30d7<\/th><th>\u8aac\u660e<\/th><th>\u8cac\u4efb\u8005<\/th><\/tr><\/thead><tbody><tr><td>1. \u88fd\u54c1\u5206\u985e<\/td><td>MDR\u30c7\u30d0\u30a4\u30b9\u30af\u30e9\u30b9\u3092\u6c7a\u5b9a\uff08\u4f8b\uff1a\u30af\u30e9\u30b9I\u3001IIa\uff09<\/td><td>\u30e1\u30fc\u30ab\u30fc<\/td><\/tr><tr><td>2. CE\u30de\u30fc\u30af<\/td><td>\u88fd\u54c1\u306eCE\u9069\u5408\u6027\u3092\u78ba\u4fdd<\/td><td>\u30e1\u30fc\u30ab\u30fc<\/td><\/tr><tr><td>3. EU\u627f\u8a8d\u4ee3\u8868\u8005\u306e\u6307\u5b9a<\/td><td>\u88fd\u9020\u5143\u304cEU\u5916\u306e\u5834\u5408\u306b\u5fc5\u8981<\/td><td>\u30e1\u30fc\u30ab\u30fc<\/td><\/tr><tr><td>4. \u8f38\u5165\u696d\u8005\u306e\u9078\u5b9a<\/td><td>\u30c7\u30d0\u30a4\u30b9\u3092\u5e02\u5834\u306b\u6295\u5165\u3059\u308b\u6cd5\u7684\u4e3b\u4f53<\/td><td>\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u307e\u305f\u306f\u30ed\u30b8\u30b9\u30c6\u30a3\u30af\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc<\/td><\/tr><tr><td>5. \u66f8\u985e\u306e\u78ba\u8a8d<\/td><td>\u9069\u5408\u5ba3\u8a00\u66f8\u3001CE\u8a3c\u660e\u66f8\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u3001UDI\u3001\u30e9\u30d9\u30eb<\/td><td>\u8f38\u5165\u8005<\/td><\/tr><tr><td>6. EUDAMED\u3078\u306e\u767b\u9332<\/td><td>\u6a5f\u5668\u304a\u3088\u3073\u7d4c\u6e08\u4e8b\u696d\u8005\u306e\u767b\u9332<\/td><td>\u88fd\u9020\u8005\/EU\u4ee3\u7406\u4eba<\/td><\/tr><tr><td>7. \u901a\u95a2\u7533\u544a<\/td><td>TARIC\u30b3\u30fc\u30c9\u3001VAT\u3001\u95a2\u7a0e\u3001CE\u78ba\u8a8d<\/td><td>\u8f38\u5165\u8005\/\u901a\u95a2\u696d\u8005<\/td><\/tr><tr><td>8. \u5e02\u8ca9\u5f8c\u76e3\u8996<\/td><td>\u82e6\u60c5\u51e6\u7406\u3001\u4e8b\u6545\u4e8b\u5831\u63d0\u4f9b<\/td><td>\u8f38\u5165\u8005\u304a\u3088\u3073EU\u4ee3\u7406\u4eba<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>\u3053\u308c\u3089\u306e\u5404\u30b9\u30c6\u30c3\u30d7\u3092\u3088\u308a\u8a73\u7d30\u306b\u5206\u89e3\u3057\u3066\u307f\u307e\u3057\u3087\u3046\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"1-determine-product-classification-under-mdr\">1. MDR\u306b\u57fa\u3065\u304f\u88fd\u54c1\u5206\u985e\u306e\u6c7a\u5b9a<\/h3>\n\n\n\n<p>\u8a3a\u65ad\u307e\u305f\u306f\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u76ee\u7684\u3067\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306f\u3001\u901a\u5e38\u6b21\u306e\u3088\u3046\u306b\u5206\u985e\u3055\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30af\u30e9\u30b9I\uff1a\u9f3b\u8154\u7528\u3001\u54bd\u982d\u7528\u30b9\u30ef\u30d6<\/li>\n\n\n\n<li>\u30af\u30e9\u30b9IIa\uff1a\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\u3001\u5a66\u4eba\u79d1\u7528\u30b9\u30af\u30e9\u30c3\u30d1\u30fc\u3001\u5b50\u5bae\u9838\u90e8\u30b5\u30f3\u30d7\u30eb\u30b3\u30ec\u30af\u30bf\u30fc<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u5206\u985e\u306f\u3001\u898f\u5236\u5be9\u67fb\u306e\u30ec\u30d9\u30eb\u3068\u9069\u5408\u6027\u8a55\u4fa1\u306b\u6307\u5b9a\u6a5f\u95a2\u304c\u5fc5\u8981\u304b\u3069\u3046\u304b\u3092\u6c7a\u5b9a\u3057\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"2-ensure-ce-marking-technical-documentation\">2. CE\u30de\u30fc\u30af\u304a\u3088\u3073\u6280\u8853\u6587\u66f8\u306e\u78ba\u4fdd<\/h3>\n\n\n\n<p>\u88fd\u9020\u8005\u306f\u6b21\u306e\u3082\u306e\u3092\u6e96\u5099\u30fb\u7dad\u6301\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9069\u5408\u5ba3\u8a00\uff08DoC\uff09<\/li>\n\n\n\n<li>CE\u8a3c\u660e\u66f8\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\uff08MDR\u4ed8\u5c5e\u66f8II\u304a\u3088\u3073III\uff09<\/li>\n\n\n\n<li>\u81e8\u5e8a\u8a55\u4fa1\u5831\u544a\u66f8<\/li>\n\n\n\n<li>\u30ea\u30b9\u30af\u7ba1\u7406\u30d5\u30a1\u30a4\u30eb<\/li>\n\n\n\n<li>\u6ec5\u83cc\u691c\u8a3c\uff08\u8a72\u5f53\u3059\u308b\u5834\u5408\uff09<\/li>\n<\/ul>\n\n\n\n<p>Hanheng\u306eCE\u30de\u30fc\u30af\u4ed8\u304d\u30b9\u30ef\u30d6\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6d41\u901a\u696d\u8005\u306f\u4e0a\u8a18\u306e\u3059\u3079\u3066\u306e\u6587\u66f8\u304c\u5229\u7528\u53ef\u80fd\u3067\u9069\u5408\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u4fe1\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"3-assign-an-eu-authorized-representative\">3. EU\u6388\u6a29\u4ee3\u8868\u8005\u306e\u6307\u5b9a<\/h3>\n\n\n\n<p>EU\u4ee3\u7406\u4eba\u306e\u9023\u7d61\u5148\u306f\u3001\u88fd\u54c1\u30e9\u30d9\u30eb\u3068\u4f7f\u7528\u8aac\u660e\u66f8\u306b\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u533b\u7642\u6a5f\u5668\u306b\u7d4c\u9a13\u304c\u3042\u308a\u3001EU\u4e3b\u7ba1\u5f53\u5c40\u3068\u306e\u5f37\u56fa\u306a\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u6709\u3059\u308b\u4ee3\u7406\u4eba\u3092\u9078\u3093\u3067\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<p>\ud83d\udca1 \u30d2\u30f3\u30c8\uff1aHanheng\u306f\u3001\u81ea\u793e\u88fd\u54c1\u30e9\u30a4\u30f3\u306b\u7cbe\u901a\u3057\u305f\u4fe1\u983c\u3067\u304d\u308bEU\u4ee3\u7406\u4eba\u3092\u63a8\u85a6\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"4-select-an-importer\">4. \u8f38\u5165\u8005\u306e\u9078\u5b9a<\/h3>\n\n\n\n<p>\u8f38\u5165\u8005\u306f\u3001\u88fd\u54c1\u304cEU\u5e02\u5834\u306b\u5165\u3063\u305f\u5f8c\u306e\u898f\u5236\u5f53\u5c40\u306e\u6700\u521d\u306e\u9023\u7d61\u5148\u3068\u306a\u308a\u307e\u3059\u3002\u3054\u81ea\u8eab\u304c\u8f38\u5165\u8005\u3068\u306a\u308b\u304b\u3001\u30ed\u30b8\u30b9\u30c6\u30a3\u30af\u30b9\u30d1\u30fc\u30c8\u30ca\u30fc\u3068\u5354\u529b\u3059\u308b\u304b\u3092\u9078\u629e\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u8f38\u5165\u8005\u306e\u8981\u4ef6\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u5e02\u5834\u6295\u5165\u524d\u306bCE\u304a\u3088\u3073\u9069\u5408\u5ba3\u8a00\u66f8\u306e\u78ba\u8a8d<\/li>\n\n\n\n<li>\u3059\u3067\u306b\u767b\u9332\u3055\u308c\u3066\u3044\u306a\u3044\u5834\u5408\u306eEUDAMED\u767b\u9332<\/li>\n\n\n\n<li>\u82e6\u60c5\u304a\u3088\u3073\u56de\u53ce\u30ed\u30b0\u306e\u7dad\u6301<\/li>\n\n\n\n<li>\u91cd\u5927\u4e8b\u6545\u4e8b\u5831\u306e\u5831\u544a<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"5-verify-product-documentation-before-shipment\">5. \u51fa\u8377\u524d\u306e\u88fd\u54c1\u6587\u66f8\u306e\u691c\u8a3c<\/h3>\n\n\n\n<p>\u8f38\u5165\u524d\u306b\u3001\u4ee5\u4e0b\u306e\u6587\u66f8\u3092\u78ba\u8a8d\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>CE\u8a3c\u660e\u66f8\u307e\u305f\u306f\u30af\u30e9\u30b9I\u306e\u81ea\u5df1\u8a8d\u8a3c<\/li>\n\n\n\n<li>\u9069\u5207\u306aEU\u8a00\u8a9e\u306b\u3088\u308b\u9069\u5408\u5ba3\u8a00\u66f8<\/li>\n\n\n\n<li>UDI\u3001EU\u4ee3\u7406\u4eba\u3001\u8f38\u5165\u8005\u4f4f\u6240\u3092\u542b\u3080\u30e9\u30d9\u30eb<\/li>\n\n\n\n<li>\u4f7f\u7528\u8aac\u660e\u66f8\uff08IFU\uff09<\/li>\n\n\n\n<li>ISO13485\u304a\u3088\u3073ISO9001\u8a3c\u660e\u66f8<\/li>\n\n\n\n<li>\u6ec5\u83cc\u304a\u3088\u3073\u751f\u4f53\u9069\u5408\u6027\u30ec\u30dd\u30fc\u30c8<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"6-register-in-eudamed\">6. EUDAMED\u3078\u306e\u767b\u9332<\/h3>\n\n\n\n<p>\u6b27\u5dde\u533b\u7642\u6a5f\u5668\u30c7\u30fc\u30bf\u30d9\u30fc\u30b9\uff08EUDAMED\uff09\u3067\u306f\u4ee5\u4e0b\u304c\u5fc5\u8981\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u57fa\u672cUDI-DI\u767b\u9332<\/li>\n\n\n\n<li>\u7d4c\u6e08\u4e8b\u696d\u8005\u767b\u9332\uff08SRN\uff09<\/li>\n\n\n\n<li>\u6a5f\u5668\u767b\u9332<\/li>\n\n\n\n<li>\u8b66\u6212\u304a\u3088\u3073\u5e02\u8ca9\u5f8c\u76e3\u8996<\/li>\n<\/ul>\n\n\n\n<p>EUDAMED\u767b\u9332\u306f\u3001\u30af\u30e9\u30b9I\u4ee5\u4e0a\u306e\u3059\u3079\u3066\u306e\u6a5f\u5668\u3067\u307e\u3059\u307e\u3059\u7fa9\u52d9\u5316\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"7-clear-eu-customs\">7. EU\u901a\u95a2\u306e\u30af\u30ea\u30a2\u30e9\u30f3\u30b9<\/h3>\n\n\n\n<p>\u901a\u95a2\u306b\u306f\u4ee5\u4e0b\u304c\u5fc5\u8981\u3067\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EORI\u756a\u53f7\uff08\u7d4c\u6e08\u4e8b\u696d\u8005\u767b\u9332\u304a\u3088\u3073\u8b58\u5225\u756a\u53f7\uff09<\/li>\n\n\n\n<li>TARIC\u30b3\u30fc\u30c9\uff08\u4f8b\uff1a\u8a3a\u65ad\u8a66\u85ac\u7528\u306e3822.00.00\uff09<\/li>\n\n\n\n<li>CE\u9069\u5408\u6027\u306e\u8a3c\u660e<\/li>\n\n\n\n<li>\u5546\u696d\u9001\u308a\u72b6<\/li>\n\n\n\n<li>\u8239\u8377\u8a3c\u5238\u307e\u305f\u306f\u822a\u7a7a\u904b\u9001\u72b6<\/li>\n\n\n\n<li>\u30d1\u30c3\u30ad\u30f3\u30b0\u30ea\u30b9\u30c8<\/li>\n\n\n\n<li>\u9069\u7528\u3055\u308c\u308b\u8f38\u5165VAT\u304a\u3088\u3073\u95a2\u7a0e\u306e\u652f\u6255\u3044<\/li>\n<\/ul>\n\n\n\n<p>\ud83d\udca1 \u6ec5\u83cc\u30b9\u30ef\u30d6\u306eTARIC\u30b3\u30fc\u30c9\uff1a3005.90.10\uff08\u533b\u7642\u7528\uff09<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"8-maintain-post-market-compliance\">8. \u5e02\u8ca9\u5f8c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u7dad\u6301<\/h3>\n\n\n\n<p>\u8f38\u5165\u5f8c\u3001\u7d99\u7d9a\u7684\u306a\u7fa9\u52d9\u304c\u751f\u3058\u307e\u3059\uff1a<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u88fd\u54c1\u30c8\u30ec\u30fc\u30b5\u30d3\u30ea\u30c6\u30a3\u306e\u7dad\u6301<\/li>\n\n\n\n<li>\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u3092\u88fd\u9020\u5143\u304a\u3088\u3073EU AR\u306b\u5831\u544a\u3059\u308b<\/li>\n\n\n\n<li>\u4e3b\u7ba1\u5f53\u5c40\u306e\u554f\u3044\u5408\u308f\u305b\u306b\u5bfe\u5fdc\u3059\u308b<\/li>\n\n\n\n<li>\u5fc5\u8981\u306b\u5fdc\u3058\u3066\u30ea\u30b3\u30fc\u30eb\u307e\u305f\u306f\u30d5\u30a3\u30fc\u30eb\u30c9\u30bb\u30fc\u30d5\u30c6\u30a3\u4fee\u6b63\u63aa\u7f6e\u3092\u7ba1\u7406\u3059\u308b<\/li>\n<\/ul>\n\n\n\n<p>\u3053\u306e\u5b8c\u5168\u30b5\u30a4\u30af\u30eb\u30ac\u30a4\u30c9\u306b\u5f93\u3046\u3053\u3068\u3067\u3001EU\u62e0\u70b9\u306e\u8f38\u5165\u696d\u8005\u304a\u3088\u3073\u6d41\u901a\u696d\u8005\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30d7\u30ed\u30bb\u30b9\u3092\u52b9\u7387\u5316\u3057\u3001\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u62e1\u5f35\u53ef\u80fd\u306a\u533b\u7642\u7528\u30b9\u30ef\u30d6\u4f9b\u7d66\u30c1\u30a7\u30fc\u30f3\u3092\u69cb\u7bc9\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<figure class=\"wp-block-gallery has-nested-images columns-default is-cropped wp-block-gallery-2 is-layout-flex wp-block-gallery-is-layout-flex\">\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2938\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2.jpg\" alt=\"\" class=\"wp-image-2938\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-Cleaning-G-0124-2-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2949\" src=\"OEM\u30b9\u30ef\u30d6\u88fd\u9020\u30d1\u30fc\u30c8\u30ca\u30fc\u30b7\u30c3\u30d7\u306e\u5229\u70b9\u306f\u4f55\u3067\u3059\u304b\uff1f- Hanheng Medical\" alt=\"\" class=\"wp-image-2949\" title=\"\" srcset=\"\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" data-srcset=\"\" \/><\/figure>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"800\" data-id=\"2943\" src=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3.jpg\" alt=\"\" class=\"wp-image-2943\" title=\"\" srcset=\"https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3.jpg 800w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-300x300.jpg 300w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-150x150.jpg 150w, https:\/\/hanheng-medical.com\/wp-content\/uploads\/2025\/04\/Polyurethane-Foam-SwabNasal-Specimen-CollectionEquipement-and-Electronic-Devices-CleaningMolded-Breakpoint-G-0132-3-768x768.jpg 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/figure>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"8-common-challenges-and-how-to-avoid-compliance-pitfalls-in-2025\">8. 2025\u5e74\u306e\u4e00\u822c\u7684\u306a\u8ab2\u984c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u843d\u3068\u3057\u7a74\u3092\u907f\u3051\u308b\u65b9\u6cd5<\/h2>\n\n\n\n<p>EU\u3078\u306e\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306e\u8f38\u5165\u306f\u5358\u7d14\u306b\u898b\u3048\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u304c\u3001\u591a\u304f\u306e\u6d41\u901a\u696d\u8005\u3084\u5378\u58f2\u696d\u8005\u306f\u3001\u914d\u9001\u306e\u9045\u5ef6\u3001\u7f70\u91d1\u306e\u767a\u751f\u3001\u307e\u305f\u306f\u898f\u5236\u5f53\u5c40\u3068\u306e\u4fe1\u983c\u95a2\u4fc2\u306e\u640d\u5931\u3092\u5f15\u304d\u8d77\u3053\u3059\u907f\u3051\u3089\u308c\u308b\u3079\u304d\u30df\u30b9\u306b\u76f4\u9762\u3057\u307e\u3059\u3002\u6700\u3082\u4e00\u822c\u7684\u306a\u843d\u3068\u3057\u7a74\u3092\u7406\u89e3\u3057\u3001\u305d\u308c\u3089\u3092\u56de\u907f\u3059\u308b\u65b9\u6cd5\u3092\u77e5\u308b\u3053\u3068\u3067\u3001\u6642\u9593\u3001\u304a\u91d1\u3001\u8a55\u5224\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"top-6-compliance-pitfalls-when-importing-medical-swabs\">\u533b\u7642\u7528\u30b9\u30ef\u30d6\u8f38\u5165\u6642\u306e\u30c8\u30c3\u30d76\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u843d\u3068\u3057\u7a74<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>\u843d\u3068\u3057\u7a74<\/th><th>\u30ea\u30b9\u30af<\/th><th>\u56de\u907f\u65b9\u6cd5<\/th><\/tr><\/thead><tbody><tr><td>CE\u30de\u30fc\u30af\u306e\u6b20\u5982\u307e\u305f\u306f\u7121\u52b9<\/td><td>\u88fd\u54c1\u62bc\u53ce\u3001\u7f70\u91d1<\/td><td>Hanheng\u306e\u3088\u3046\u306aCE\u6e96\u62e0\u306e\u88fd\u9020\u5143\u304b\u3089\u306e\u307f\u8abf\u9054\u3059\u308b<\/td><\/tr><tr><td>EU\u8a8d\u5b9a\u4ee3\u8868\u8005\u306e\u6307\u5b9a\u306a\u3057<\/td><td>\u7a0e\u95a2\u62d2\u5426<\/td><td>\u51fa\u8377\u524d\u306bAR\u3092\u6307\u5b9a\u3059\u308b<\/td><\/tr><tr><td>\u88fd\u54c1\u5206\u985e\u306e\u8aa4\u308a<\/td><td>\u76e3\u67fb\u5931\u6557\u3001\u5e02\u5834\u7981\u6b62<\/td><td>\u88fd\u9020\u5143\u306bMDR\u5206\u985e\u3092\u78ba\u8a8d\u3059\u308b<\/td><\/tr><tr><td>\u6280\u8853\u6587\u66f8\u306e\u4e0d\u5099<\/td><td>\u7a0e\u95a2\u307e\u305f\u306f\u76e3\u8996\u3067\u306e\u9045\u5ef6<\/td><td>\u6ce8\u6587\u524d\u306b\u5b8c\u5168\u306a\u6587\u66f8\u3092\u8981\u6c42\u3059\u308b<\/td><\/tr><tr><td>EU\u8a00\u8a9e\u4ee5\u5916\u306e\u30e9\u30d9\u30eb\u8868\u793a<\/td><td>\u975e\u6e96\u62e0<\/td><td>\u30e9\u30d9\u30eb\u3068\u4f7f\u7528\u8aac\u660e\u66f8\u304c\u7ffb\u8a33\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/td><\/tr><tr><td>\u5305\u88c5\u4e0a\u306eUDI\u306e\u6b20\u5982<\/td><td>\u898f\u5236\u7f70\u5247<\/td><td>\u88fd\u9020\u5143\u304cUDI\u3092\u4ed8\u4e0e\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"real-world-import-challenges\">\u5b9f\u969b\u306e\u8f38\u5165\u8ab2\u984c<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u30c9\u30a4\u30c4\u306e\u5927\u898f\u6a21\u8a3a\u65ad\u6d41\u901a\u696d\u8005\u304c\u3001CE\u6587\u66f8\u306e\u6b20\u5982\u306b\u3088\u308a5,000\u672c\u306e\u9838\u7ba1\u30b9\u30ef\u30d6\u3092\u7a0e\u95a2\u3067\u62d8\u675f\u3055\u308c\u307e\u3057\u305f\u3002<\/li>\n\n\n\n<li>\u30d5\u30e9\u30f3\u30b9\u306e\u75c5\u9662\u8abf\u9054\u6a5f\u95a2\u304c\u3001\u4f7f\u7528\u8aac\u660e\u66f8\u304c\u4e2d\u56fd\u8a9e\u3068\u82f1\u8a9e\u306e\u307f\u3060\u3063\u305f\u305f\u3081\u3001\u51fa\u8377\u3092\u62d2\u5426\u3057\u307e\u3057\u305f\u3002<\/li>\n\n\n\n<li>\u82f1\u56fd\u62e0\u70b9\u306e\u8f38\u5165\u696d\u8005\uff08Brexit\u524d\uff09\u304c\u3001\u30af\u30e9\u30b9IIa\u30c7\u30d0\u30a4\u30b9\u8f38\u5165\u5f8c\u306bEUDAMED\u3078\u306e\u767b\u9332\u3092\u6020\u3063\u305f\u3068\u3057\u3066\u7f70\u91d1\u3092\u79d1\u3055\u308c\u307e\u3057\u305f\u3002<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"how-to-stay-ahead-in-2025\">2025\u5e74\u306b\u5148\u624b\u3092\u6253\u3064\u65b9\u6cd5<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>EU\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u5b9f\u7e3e\u304c\u8a3c\u660e\u3055\u308c\u305f\u4fe1\u983c\u3067\u304d\u308b\u30e1\u30fc\u30ab\u30fc\u3001\u4f8b\u3048\u3070Hanheng\u306e\u3088\u3046\u306a\u4f01\u696d\u306e\u307f\u3068\u5354\u529b\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n\n\n\n<li>\u5404\u6ce8\u6587\u306b\u5bfe\u3057\u3066\u51fa\u8377\u524d\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8\u76e3\u67fb\u3092\u5b9f\u65bd\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n\n\n\n<li>\u533b\u7642\u6a5f\u5668\u30d7\u30ed\u30c8\u30b3\u30eb\u306b\u7cbe\u901a\u3057\u305f\u8f38\u5165\u4ee3\u7406\u5e97\u307e\u305f\u306f\u901a\u95a2\u696d\u8005\u3092\u5229\u7528\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n\n\n\n<li>\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u533b\u7642\u6a5f\u5668\u30bb\u30af\u30bf\u30fc\u304b\u3089\u306e\u66f4\u65b0\u60c5\u5831\u3092\u8cfc\u8aad\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n\n\n\n<li>\u8f38\u5165\u304a\u3088\u3073\u6d41\u901a\u30d7\u30ed\u30bb\u30b9\u306e\u3059\u3079\u3066\u306e\u6bb5\u968e\u3092\u6587\u66f8\u5316\u3057\u3066\u304f\u3060\u3055\u3044<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"compliance-checklist-for-eu-importers\">EU\u8f38\u5165\u696d\u8005\u5411\u3051\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30c1\u30a7\u30c3\u30af\u30ea\u30b9\u30c8<\/h3>\n\n\n\n<p>\u2705 CE\u30de\u30fc\u30af\u3068MDR\u9069\u5408\u6027\u3092\u78ba\u8a8d\u3059\u308b<br>\u2705 EU\u627f\u8a8d\u4ee3\u8868\u8005\u304c\u5272\u308a\u5f53\u3066\u3089\u308c\u767b\u9332\u3055\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<br>\u3059\u3079\u3066\u306e\u6280\u8853\u6587\u66f8\u3092\u30ec\u30d3\u30e5\u30fc\u3057\u4fdd\u7ba1\u3059\u308b<br>\u30e9\u30d9\u30eb\u3068\u4f7f\u7528\u8aac\u660e\u66f8\u304c\u8a00\u8a9e\u30fb\u6cd5\u7684\u8981\u4ef6\u3092\u6e80\u305f\u3057\u3066\u3044\u308b\u3053\u3068\u3092\u78ba\u8a8d\u3059\u308b<br>\u6a5f\u5668\u3068\u4e8b\u696d\u8005\u3092EUDAMED\u306b\u767b\u9332\u3059\u308b<br>\u5e02\u8ca9\u5f8c\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u3068\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u5831\u544a\u3092\u76e3\u8996\u3059\u308b<\/p>\n\n\n\n<p>EU\u533b\u7642\u6d88\u8017\u54c1\u5e02\u5834\u3067\u306e\u9577\u671f\u7684\u306a\u6210\u529f\u904b\u55b6\u306e\u9375\u306f\u3001\u7a4d\u6975\u7684\u306a\u5bfe\u5fdc\u306b\u3042\u308a\u307e\u3059\u2014\u53cd\u5fdc\u7684\u306a\u3082\u306e\u3067\u306f\u306a\u304f\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"9-faqs-navigating-eu-import-rules-for-medical-swabs\">9. FAQ\uff1aEU\u533b\u7642\u30b9\u30ef\u30d6\u8f38\u5165\u898f\u5247\u306e\u30ca\u30d3\u30b2\u30fc\u30b7\u30e7\u30f3<\/h2>\n\n\n\n<p>\u4ee5\u4e0b\u306f\u3001B2B\u30d0\u30a4\u30e4\u30fc\u3001\u8f38\u5165\u696d\u8005\u3001\u533b\u7642\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u304b\u30892025\u5e74\u306eEU\u3078\u306e\u30b9\u30ef\u30d6\u8f38\u5165\u306b\u95a2\u3059\u308b\u6700\u3082\u983b\u7e41\u306b\u5bc4\u305b\u3089\u308c\u308b\u8cea\u554f\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q1-do-all-medical-swabs-require-ce-marking\">Q1: \u3059\u3079\u3066\u306e\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306bCE\u30de\u30fc\u30af\u304c\u5fc5\u8981\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u306f\u3044\u3002\u30b9\u30ef\u30d6\u304c\u533b\u7642\u307e\u305f\u306f\u8a3a\u65ad\u7528\u9014\uff08\u4f8b\uff1a\u9f3b\u54bd\u982d\u7528\u3001\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\uff09\u306e\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u5834\u5408\u3001MDR 2017\/745\u306b\u57fa\u3065\u304dCE\u30de\u30fc\u30af\u304c\u5fc5\u8981\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q2-what-class-are-medical-swabs-under-mdr\">Q2: MDR\u306b\u304a\u3051\u308b\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306e\u30af\u30e9\u30b9\u306f\u4f55\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9f3b\/\u5589\u30b9\u30ef\u30d6\uff1a\u30af\u30e9\u30b9I<\/li>\n\n\n\n<li>\u5b50\u5bae\u9838\u90e8\u30d6\u30e9\u30b7\/\u30b9\u30af\u30e9\u30c3\u30d1\u30fc\uff1a\u30af\u30e9\u30b9IIa<\/li>\n\n\n\n<li>\u81ea\u5df1\u63a1\u53d6\u30ad\u30c3\u30c8\uff1a\u7528\u9014\u306b\u3088\u308a\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u3057\u3070\u3057\u3070\u30af\u30e9\u30b9IIa<\/li>\n<\/ul>\n\n\n\n<p>\u5e38\u306b\u7528\u9014\u3092\u78ba\u8a8d\u3057\u3001\u30e1\u30fc\u30ab\u30fc\u306e\u5206\u985e\u6839\u62e0\u3092\u76f8\u8ac7\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q3-what-documents-should-i-request-from-a-supplier-like-hanheng\">Q3: Hanheng\u306e\u3088\u3046\u306a\u30b5\u30d7\u30e9\u30a4\u30e4\u30fc\u304b\u3089\u3069\u306e\u3088\u3046\u306a\u66f8\u985e\u3092\u4f9d\u983c\u3059\u3079\u304d\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>\u9069\u5408\u5ba3\u8a00\u66f8<\/li>\n\n\n\n<li>CE\u8a3c\u660e\u66f8\uff08\u30af\u30e9\u30b9IIa\u306e\u5834\u5408\uff09<\/li>\n\n\n\n<li>\u6280\u8853\u6587\u66f8\uff08\u4ed8\u5c5e\u66f8II\uff09<\/li>\n\n\n\n<li>\u6ec5\u83cc\u30ec\u30dd\u30fc\u30c8<\/li>\n\n\n\n<li>ISO13485\u304a\u3088\u3073ISO9001\u8a8d\u8a3c<\/li>\n\n\n\n<li>EU\u8a00\u8a9e\u3067\u306e\u4f7f\u7528\u8aac\u660e\u66f8\u3068\u30e9\u30d9\u30eb<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q4-can-i-import-swabs-without-an-eu-authorized-representative\">Q4: EU\u627f\u8a8d\u4ee3\u8868\u8005\u306a\u3057\u3067\u30b9\u30ef\u30d6\u3092\u8f38\u5165\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u3044\u3044\u3048\u3002\u30e1\u30fc\u30ab\u30fc\u304cEU\u5916\u306e\u5834\u5408\u3001\u627f\u8a8d\u4ee3\u8868\u8005\u306f\u5fc5\u9808\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q5-does-hanheng-support-eu-import-compliance\">Q5: Hanheng\u306fEU\u8f38\u5165\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u306f\u3044\u3002Hanheng\u306fMDR\u6e96\u62e0\u306e\u5b8c\u5168\u306a\u6587\u66f8\u3001CE\u30de\u30fc\u30af\u4ed8\u304d\u88fd\u54c1\u3092\u63d0\u4f9b\u3057\u3001\u533b\u7642\u6a5f\u5668\u8f38\u5165\u306b\u7d4c\u9a13\u8c4a\u5bcc\u306aEU AR\u304a\u3088\u3073\u7269\u6d41\u30d1\u30fc\u30c8\u30ca\u30fc\u3092\u63a8\u5968\u3067\u304d\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q6-are-there-import-duties-on-medical-swabs\">Q6: \u533b\u7642\u7528\u30b9\u30ef\u30d6\u306b\u8f38\u5165\u95a2\u7a0e\u306f\u304b\u304b\u308a\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u533b\u7642\u7528\u30b9\u30ef\u30d6\u306f\u7279\u5b9a\u306eTARIC\u30b3\u30fc\u30c9\u306e\u4e0b\u3067\u95a2\u7a0e\u306e\u8efd\u6e1b\u307e\u305f\u306f\u514d\u9664\u306e\u5bfe\u8c61\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u305f\u3060\u3057\u3001\u56fd\u306b\u3088\u308a\u8f38\u5165VAT\u306f\u9069\u7528\u3055\u308c\u307e\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q7-can-i-private-label-hanheng-products-for-my-eu-brand\">Q7: Hanheng\u88fd\u54c1\u3092EU\u30d6\u30e9\u30f3\u30c9\u5411\u3051\u306b\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30e9\u30d9\u30eb\u3067\u304d\u307e\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u306f\u3044\u3002Hanheng\u306fCE\u6e96\u62e0\u306e\u6587\u66f8\u4ed8\u304dOEM\/\u30d7\u30e9\u30a4\u30d9\u30fc\u30c8\u30e9\u30d9\u30eb\u30b5\u30fc\u30d3\u30b9\u3092\u63d0\u4f9b\u3057\u3001\u81ea\u793e\u30d6\u30e9\u30f3\u30c9\u3067\u62e1\u5927\u3057\u305f\u3044\u30c7\u30a3\u30b9\u30c8\u30ea\u30d3\u30e5\u30fc\u30bf\u30fc\u306b\u6700\u9069\u3067\u3059\u3002<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"q8-how-do-i-ensure-my-products-are-registered-in-eudamed\">Q8: \u88fd\u54c1\u3092EUDAMED\u306b\u767b\u9332\u3059\u308b\u306b\u306f\u3069\u3046\u3059\u308c\u3070\u3088\u3044\u3067\u3059\u304b\uff1f<\/h3>\n\n\n\n<p>\u30e1\u30fc\u30ab\u30fc\u304a\u3088\u3073EU AR\u3068\u9023\u643a\u3057\u3001\u57fa\u672cUDI-DI\u3068\u88fd\u54c1\u30ea\u30b9\u30c8\u3092EUDAMED\u30b7\u30b9\u30c6\u30e0\u306b\u767b\u9332\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n\n\n\n<hr class=\"wp-block-separator has-alpha-channel-opacity\"\/>\n\n\n\n<p>\ud83e\uddea EU\u6e96\u62e0\u306e\u533b\u7642\u7528\u30b9\u30ef\u30d6\u30b5\u30d7\u30e9\u30a4\u30c1\u30a7\u30fc\u30f3\u3092\u69cb\u7bc9\u3059\u308b\u6e96\u5099\u306f\u3067\u304d\u307e\u3057\u305f\u304b\uff1f<\/p>\n\n\n\n<p><a href=\"https:\/\/hanheng-medical.com\/ja\/contact-us\/\">\u6c5f\u8607\u6f22\u6052\u533b\u7642\u6280\u8853 <\/a>\u306f\u9ad8\u6027\u80fd\u3067CE\u8a8d\u5b9a\u306e\u30b5\u30f3\u30d7\u30ea\u30f3\u30b0\u6d88\u8017\u54c1\u306e\u4fe1\u983c\u3067\u304d\u308b\u30d1\u30fc\u30c8\u30ca\u30fc\u3067\u3059\u3002\u898b\u7a4d\u3082\u308a\u3001\u6587\u66f8\u30ec\u30d3\u30e5\u30fc\u3001\u307e\u305f\u306f\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u76f8\u8ac7\u306e\u305f\u3081\u306b\u3001\u4eca\u65e5\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\uff1a<\/p>\n\n\n\n<p>\ud83c\udf10 \u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\uff1a <a href=\"https:\/\/hanheng-medical.com\/ja\/\" target=\"_blank\" rel=\"noreferrer noopener\">www.hanheng-medical.com<\/a><br>\ud83d\udce7 E\u30e1\u30fc\u30eb\uff1a <a href=\"mailto:sales@hanhengmed.com\" target=\"_blank\" rel=\"noreferrer noopener\">sales@hanhengmed.com<\/a><\/p>\n\n\n\n<p>Hanheng\u3068\u4e00\u7dd2\u306b\u3001\u3088\u308a\u30b9\u30de\u30fc\u30c8\u3067\u5b89\u5168\u306a\u8f38\u5165\u3092\u59cb\u3081\u307e\u3057\u3087\u3046 \u2014 EU\u5e02\u5834\u5411\u3051\u533b\u7642\u7528\u30b9\u30ef\u30d6\u88fd\u9020\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u30ea\u30fc\u30c0\u30fc\u3002<\/p>\n\n\n\n<p><\/p>","protected":false},"excerpt":{"rendered":"<p>1. \u5c0e\u5165: 2025\u5e74\u306bEU\u306e\u533b\u7642\u7528\u30b9\u30ef\u30d6\u8f38\u5165\u898f\u5236\u3092\u7406\u89e3\u3059\u308b\u91cd\u8981\u6027 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