{"id":22700,"date":"2024-09-27T15:07:21","date_gmt":"2024-09-27T14:07:21","guid":{"rendered":"https:\/\/rephinestg.wpengine.com\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/medtech-eu%e8%a6%8f%e5%88%b6%e3%82%a2%e3%83%83%e3%83%97%e3%83%87%e3%83%bc%e3%83%88\/"},"modified":"2026-05-08T10:19:45","modified_gmt":"2026-05-08T09:19:45","slug":"medtech-eu%e8%a6%8f%e5%88%b6%e3%82%a2%e3%83%83%e3%83%97%e3%83%87%e3%83%bc%e3%83%88","status":"publish","type":"page","link":"https:\/\/www.rephine.com\/ja\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8\/medtech-eu%e8%a6%8f%e5%88%b6%e3%82%a2%e3%83%83%e3%83%97%e3%83%87%e3%83%bc%e3%83%88\/","title":{"rendered":"MedTech EU\u898f\u5236\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"22700\" class=\"elementor elementor-22700 elementor-13157\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-355f101 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"355f101\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-65790609\" data-id=\"65790609\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-708c0c72 elementor-widget elementor-widget-heading\" data-id=\"708c0c72\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MedTech EU\u898f\u5236\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ff9b414 elementor-widget elementor-widget-text-editor\" data-id=\"ff9b414\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #ffffff;\">\u6700\u65b0\u306eMedTech\u898f\u5236\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u5e38\u306b\u60c5\u5831\u3092\u5165\u624b<\/span><\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-567d2610 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"567d2610\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wide\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-6edcad5f\" data-id=\"6edcad5f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-a3860ba elementor-widget elementor-widget-image\" data-id=\"a3860ba\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"1024\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-1024x1024.png\" class=\"attachment-large size-large wp-image-22701\" alt=\"\u533b\u7642\u6a5f\u5668\u30b5\u30fc\u30d3\u30b9\u30a4\u30e1\u30fc\u30b8.png\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-1024x1024.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-300x300.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-150x150.png 150w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-768x768.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-600x600.png 600w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image-740x740.png 740w, https:\/\/www.rephine.com\/wp-content\/uploads\/2023\/07\/Medical-Devices-service-image.png 1292w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-750469bd\" data-id=\"750469bd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4de474e0 elementor-widget elementor-widget-heading\" data-id=\"4de474e0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-medium\">MedTech\u696d\u754c\u5411\u3051\u306e\u898f\u5236\u306b\u95a2\u3059\u308b\u6d1e\u5bdf<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-214d787d elementor-widget__width-initial elementor-widget-mobile__width-inherit elementor-widget-laptop__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"214d787d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"color: var( --e-global-color-primary ); font-family: var( --e-global-typography-primary-font-family ), Sans-serif; font-weight: var( --e-global-typography-primary-font-weight );\">\u6025\u901f\u306b\u9032\u5316\u3059\u308b\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073MedTech\u5206\u91ce\u3067\u306f\u3001\u898f\u5236\u306e\u5909\u66f4\u306b\u5e38\u306b\u5148\u3093\u3058\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002\u5f53\u793e\u306e\u5c02\u7528\u30da\u30fc\u30b8\u3067\u306f\u3001\u304a\u5ba2\u69d8\u306e\u30d3\u30b8\u30cd\u30b9\u304c\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3057\u3001\u5e38\u306b\u6700\u65b0\u306e\u60c5\u5831\u3092\u5165\u624b\u3067\u304d\u308b\u3088\u3046\u3001\u6700\u65b0\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u3001\u898f\u5236\u3001\u304a\u3088\u3073\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u306e\u5305\u62ec\u7684\u306a\u6982\u8981\u3092\u63d0\u4f9b\u3057\u3066\u3044\u307e\u3059\u3002\u6700\u65b0\u306eMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\u304b\u3089EU\u898f\u5236\u306e\u4fee\u6b63\u307e\u3067\u3001\u8907\u96d1\u306a\u898f\u5236\u306e\u72b6\u6cc1\u3092\u4e57\u308a\u5207\u308b\u305f\u3081\u306b\u5fc5\u8981\u306a\u77e5\u8b58\u3092\u304a\u5ba2\u69d8\u306b\u63d0\u4f9b\u3057\u307e\u3059\u3002  <\/span><\/p><p>IVDR\u304a\u3088\u3073MDR\u306e\u6539\u8a02\u3001Q&#038;A\u306e\u30ea\u30ea\u30fc\u30b9\u3001\u81e8\u5e8a\u8a55\u4fa1\u304a\u3088\u3073\u9069\u5408\u6027\u8a55\u4fa1\u306b\u304a\u3051\u308b\u91cd\u8981\u306a\u5909\u66f4\u306a\u3069\u3001\u304a\u5ba2\u69d8\u306e\u898f\u5236\u306e\u904e\u7a0b\u3092\u30b5\u30dd\u30fc\u30c8\u3059\u308b\u305f\u3081\u306b\u8a2d\u8a08\u3055\u308c\u305f\u6700\u65b0\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u3054\u89a7\u304f\u3060\u3055\u3044\u3002<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9b9c0df elementor-align-left elementor-widget elementor-widget-button\" data-id=\"9b9c0df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-md\" href=\"https:\/\/www.rephine.com\/ja\/%e3%81%8a%e5%95%8f%e3%81%84%e5%90%88%e3%82%8f%e3%81%9b\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">\u304a\u554f\u3044\u5408\u308f\u305b<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-5c7f201e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"5c7f201e\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wide\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-30e2c95f\" data-id=\"30e2c95f\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-74b46d68 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"74b46d68\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #f08200;\"><strong>\u898f\u5236\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8<\/strong><\/span><\/h2><p><strong>2025\u5e745\u6708\uff1a<\/strong><\/p><ul><li>\u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304f\u65b0\u3057\u3044\u6307\u5b9a notified body\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1017272?organizationVersion=7\">DNV Product Assurance AS\uff08Notified Body number 2460\uff09<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044\u88fd\u9020\u696d\u8005\u30a4\u30f3\u30b7\u30c7\u30f3\u30c8\u30ec\u30dd\u30fc\u30c8\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance\/pmsv-reporting-forms_en\">MIR version 7.3.1<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044MedTech\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u30da\u30fc\u30d1\u30fc\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/05\/medtech-europe_mdr_ivdr_leaflet_four-urgent-targeted-measures-1.pdf\">Towards a revised EU Regulatory Framework for medical devices<\/a>.<\/strong><\/span><\/li><li>\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u5065\u5eb7\u30fb\u98df\u6599\u5b89\u5168\u4fdd\u969c\u7dcf\u5c40\uff08DG SANTE\uff09\u304c\u59d4\u8a17\u3057\u305f<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/af3e94d1-47e8-4f5b-8fe4-677e3d21cb5d_en?filename=md_availability_study_survey-hsp-2024_pres_en.pdf\">\ud835\udfed\ud835\udfee\ud835\ude01\ud835\uddf5 \ud835\udde1\ud835\uddfc\ud835\ude01\ud835\uddf6\ud835\uddf3\ud835\uddf6\ud835\uddf2\ud835\uddf1 \ud835\uddd5\ud835\uddfc\ud835\uddf1\ud835\uddf6\ud835\uddf2\ud835\ude00 (\ud835\udde1\ud835\uddd5) \ud835\ude00\ud835\ude02\ud835\uddff\ud835\ude03\ud835\uddf2\ud835\ude06<\/a><\/strong><\/span>\u306e\u7d50\u679c\u3002<em>36\u304b\u6708\u9593\u306e\u8abf\u67fb<\/em><em>S<\/em><em>upporting the Monitoring of the Availability of Medical Devices on the EU Market<\/em><\/li><li>\u65b0\u3057\u3044MedTech Europe\u30ac\u30a4\u30c9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/05\/250522_medtech-europe_emdn-booklet_final-dp.pdf\">Use of the European Medical Device Nomenclature (EMDN)<\/a>.<\/strong><\/span>\u306e\u5b9f\u7528\u7684\u306a\u30ac\u30a4\u30c9<\/li><\/ul><p><strong>2025\u5e744\u6708\uff1a<\/strong><\/p><ul><li>\u65b0\u3057\u3044IMDRF Terms of Reference\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.imdrf.org\/documents\/imdrf-terms-reference\">IMDRF\/MC\/N1FINAL:2025(Edition 8)<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044\u6b27\u5dde\u59d4\u54e1\u4f1a\u5b9f\u65bd\u6c7a\u5b9a\uff1a\u533b\u7642\u6a5f\u5668\u306e\u6ec5\u83cc\u306b\u95a2\u3059\u308b\u6574\u5408\u898f\u683c\u306b\u95a2\u3059\u308b\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092021\/1195\u3092\u4fee\u6b63\u3059\u308b2025\u5e744\u67088\u65e5\u306e<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/679\/oj\/eng\">Implementing Decision (EU) 2025\/679<\/a><\/strong><\/span>\u3002<\/li><li>\u65b0\u3057\u3044\u6b27\u5dde\u59d4\u54e1\u4f1a\u5b9f\u65bd\u6c7a\u5b9a\uff1a\u6551\u6025\u8eca\u3067\u4f7f\u7528\u3055\u308c\u308b\u533b\u7642\u7528\u624b\u888b\u306e\u5358\u56de\u4f7f\u7528\u3001\u533b\u7642\u6a5f\u5668\u306e\u6ec5\u83cc\u3001\u304a\u3088\u3073\u60a3\u8005\u306e\u53d6\u308a\u6271\u3044\u88c5\u7f6e\u306b\u95a2\u3059\u308b\u6574\u5408\u898f\u683c\u306b\u95a2\u3059\u308b\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092021\/1182\u3092\u4fee\u6b63\u3059\u308b2025\u5e744\u67088\u65e5\u306e<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2025\/681\/oj\/eng\">Implementing Decision (EU) 2025\/681<\/a><\/strong><\/span>\u3002<\/li><li>\u65b0\u3057\u3044Team NB Position Paper\uff1a<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2025\/04\/Team-NB-PositionPaper-IVDR-Certification-Process-Consensus-Document-V1-20250409.pdf\">IVDR Certification Process<\/a><\/strong><\/span>\uff08\u4e8b\u524d\u7533\u8acb\u3001\u7533\u8acb\u3001\u304a\u3088\u3073\u7533\u8acb\u5f8c\u30d5\u30a7\u30fc\u30ba\u3092\u542b\u3080\uff09\u2013 \u30b3\u30f3\u30bb\u30f3\u30b5\u30b9\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\uff08\u30d0\u30fc\u30b8\u30e7\u30f31\uff09\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fTeam NB Position Paper\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2025\/04\/Team-NB-PositionPaper-EU-AI-Act-V2-20250409.pdf\">European Artificial Intelligence Act<\/a><\/strong><\/span>\uff08\u30d0\u30fc\u30b8\u30e7\u30f32\uff09<\/li><li>\u66f4\u65b0\u3055\u308c\u305fTeam NB Position Paper\uff1a\u533b\u7642\u6a5f\u5668\u898f\u5247\uff08EU\uff092017\/745\u306e\u9644\u5c5e\u66f8II\u304a\u3088\u3073III\u306b\u57fa\u3065\u304f<a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2025\/04\/Team-NB-PositionPaper-BPG-TechnicalDocEU-MDR-2017-745-V3-20250409.pdf\"><span style=\"text-decoration: underline;\"><strong>Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017\/745<\/strong><\/span><\/a>\u306e\u63d0\u51fa\u306b\u95a2\u3059\u308b\u30d9\u30b9\u30c8\u30d7\u30e9\u30af\u30c6\u30a3\u30b9\u30ac\u30a4\u30c0\u30f3\u30b9\uff08\u30d0\u30fc\u30b8\u30e7\u30f33\uff09\u3002<\/li><li>\u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304f\u65b0\u3057\u3044\u6307\u5b9a notified body\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1017001?organizationVersion=21\">IMQ \u2013 Istituto Italiano del Marchio di Qualit\u00e0 S.p.A. (Notified Body number 0051)<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044AEMPS\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.aemps.gob.es\/productosSanitarios\/docs\/2025\/guia-comercializacion-ps-2025.pdf\">Guide for the commercialization of Medical Devices in Spain<\/a>.<\/strong><\/span><\/li><li>\u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304f\u65b0\u3057\u3044\u6307\u5b9a notified body\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/webgate.ec.europa.eu\/single-market-compliance-space\/notified-bodies\/notifications\/1017742?organizationVersion=13\">SGS Belgium (Notified Body number 1639)<\/a>.<\/strong><\/span><\/li><\/ul><p><strong>2025\u5e743\u6708\uff1a<\/strong><\/p><ul><li>\u65b0\u3057\u3044Team NB Press Release\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2025\/03\/PressRelease-WP3-Task3.3-Certificates-with-Conditions-20250312.pdf\">Certificates with Conditions \u2013 Team NB Statement<\/a>.<\/strong><\/span><\/li><li>\u66f4\u65b0\u3055\u308c\u305f\u9644\u5c5e\u66f8<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.imdrf.org\/documents\/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes\">IMDRF\/AE WG\/N43FINAL<\/a><\/strong><\/span>\uff082025\u5e743\u6708\uff09\uff1a\u5206\u985e\u3055\u308c\u305f\u6709\u5bb3\u4e8b\u8c61\u5831\u544a\uff08AER\uff09\u306e\u7528\u8a9e\uff1a\u7528\u8a9e\u3001\u7528\u8a9e\u96c6\u3001\u304a\u3088\u3073\u30b3\u30fc\u30c9<\/li><li>\u65b0\u3057\u3044MedTech Europe Position Paper\uff1a\u88fd\u9020\u696d\u8005\u3068Notified Body\u9593\u306e\u4e8b\u524d\u63d0\u51fa\u5bfe\u8a71\u306e\u4e00\u74b0\u3068\u3057\u3066\u306e<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/02\/joint-paper-_mte_aesgp_mpp_cocir_clinical-strategy-pre-submission.pdf\">Clinical strategy as part of pre-submission dialogue between manufacturer and Notified Body<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044\u6b27\u5dde\u59d4\u54e1\u4f1a\u30a4\u30cb\u30b7\u30a2\u30c1\u30d6\uff1a\u533b\u7642\u5f93\u4e8b\u8005\u306e\u307f\u304c\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u305f\u3059\u3079\u3066\u306e\u533b\u7642\u6a5f\u5668\u3078\u306e\u96fb\u5b50\u4f7f\u7528\u8aac\u660e\u66f8\uff08eIFU\uff09\u306e\u4f7f\u7528\u3092\u62e1\u5927\u3059\u308b<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14470-Medical-devices-electronic-instructions-for-use_en\">amendment to implementing Regulation (EU) 2021\/2226<\/a> <\/strong><\/span>\u3002<\/li><li>\u65b0\u3057\u3044MedTech Europe Reflection paper\uff1a<span style=\"text-decoration: underline;\"><strong>E<a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/02\/20250217_mte-and-cocir_reflection-paper-on-mdsap.pdf\">uropean medical technology industry calls for the EU to join the Medical Device Single Audit Program (MDSAP) as a Full Member<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044MedTech Europe Decision Guide Flowchart\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/03\/decision-guide-flowchart_notifications-mdr_ivdr_art10a_final.pdf\">Article 10a MDR \/ IVDR: Notification in Case of Interruption or Discontinuation of Supply<\/a>.<\/strong><\/span><\/li><li>\u65b0\u3057\u3044MedTech Europe Position Paper\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/wp-content\/uploads\/2025\/03\/joint-discussion-paper-on-future-governance-of-medical-technologies.pdf\">Joint Discussion Paper on the Future Governance of Medical Technologies in Europe<\/a>.<\/strong><\/span><\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev4-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2025-03-18_en\">MDCG 2020-16 Rev.4<\/a><\/strong><\/span> \u2013 \u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304fin vitro\u8a3a\u65ad\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u898f\u5247\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fISO\u898f\u683c\uff1a<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/www.iso.org\/standard\/86270.html\">ISO 15223-1:2021\/Amd 1:2025<\/a> <\/strong><\/span>&#8211; \u533b\u7642\u6a5f\u5668\u2014\u88fd\u9020\u696d\u8005\u304c\u63d0\u4f9b\u3059\u308b\u60c5\u5831\u3067\u4f7f\u7528\u3055\u308c\u308b\u8a18\u53f7\u2014\u30d1\u30fc\u30c81\uff1a\u4e00\u822c\u7684\u306a\u8981\u4ef6<\/li><li>\u65b0\u3057\u3044AEMPS Information Note\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.aemps.gob.es\/tag\/seguridad-8\/\">PS 2025\/15<\/a> &#8211;<\/strong><\/span> \u30b9\u30da\u30a4\u30f3\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u81e8\u5e8a\u8abf\u67fb\u5831\u544a\u66f8\u306e\u516c\u958b\u624b\u9806<\/li><\/ul><p><strong>2025\u5e742\u6708\uff1a<\/strong><\/p><ul><li>\u30b9\u30da\u30a4\u30f3\u533b\u85ac\u54c1\u30fb\u533b\u7642\u6a5f\u5668\u5e81\uff08AEMPS\u3001<em>Agencia Espa\u00f1ola de Productos Sanitarios<\/em>\uff09\u306f\u3001\u305d\u306e\u6d3b\u52d5\u3092\u5e02\u6c11\u306b\u8fd1\u3065\u3051\u308b\u305f\u3081\u306b\u3001<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.instagram.com\/aemps.gob\/\">profile on Instagram<\/a><\/strong><\/span>\u3092\u958b\u59cb\u3057\u307e\u3059\u3002\u4ed6\u306e\u30bd\u30fc\u30b7\u30e3\u30eb\u30cd\u30c3\u30c8\u30ef\u30fc\u30af\u306b\u304a\u3051\u308bAEMPS\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\uff1a<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/x.com\/AEMPSGOB\">X<\/a><\/strong><\/span>\u3001\u3059\u3079\u3066\u306e\u30bf\u30a4\u30d7\u306e\u8996\u8074\u8005\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/www.linkedin.com\/company\/agencia-espa-ola-de-medicamentos-y-productos-sanitarios\/\">LinkedIn<\/a><\/strong><\/span>\u3001\u5c02\u9580\u5206\u91ce\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u307e\u3059\u3002\u304a\u3088\u3073<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.youtube.com\/AempsGobEsinfo\">YouTube<\/a><\/strong><\/span>\u3001\u30aa\u30fc\u30c7\u30a3\u30aa\u30d3\u30b8\u30e5\u30a2\u30eb\u30b3\u30f3\u30c6\u30f3\u30c4\u306b\u7126\u70b9\u3092\u5f53\u3066\u3066\u3044\u307e\u3059\u3002 <\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/9c9c532f-013a-477c-9378-0a9e714e5549_en?filename=md_mdcg_qa_requirements_notified_bodies_en.pdf\">MDCG 2019-6 rev.5<\/a> <\/strong><\/span>&#8211; \u8cea\u554f<em>\u3068\u56de\u7b54\u2013 Notified Body\u306b\u95a2\u9023\u3059\u308b\u8981\u4ef6<\/em>\u3002<\/li><li>\u6b27\u5dde\u59d4\u54e1\u4f1a<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-clinical-investigations-and-performance-studies\/pilot-coordinated-assessment-cips_en\">call for applications<\/a><\/strong><\/span>\u898f\u5247\uff08EU\uff092017\/745\uff08MDR\uff09\u306e\u7b2c78\u6761\u304a\u3088\u3073\u898f\u5247\uff08EU\uff092017\/746\uff08IVDR\uff09\u306e\u7b2c74\u6761\u306b\u5f93\u3044\u3001\u8907\u6570\u306e\u52a0\u76df\u56fd\u306b\u304a\u3051\u308b\u81e8\u5e8a\u8abf\u67fb\uff08CI\uff09\u304a\u3088\u3073\u30d1\u30d5\u30a9\u30fc\u30de\u30f3\u30b9\u8abf\u67fb\uff08PS\uff09\u306e\u30d1\u30a4\u30ed\u30c3\u30c8\u8abf\u6574\u8a55\u4fa1\u3002<\/li><li>\u65b0\u3057\u3044\u6b27\u5dde\u59d4\u54e1\u4f1a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/digital-strategy.ec.europa.eu\/en\/library\/commission-publishes-guidelines-prohibited-artificial-intelligence-ai-practices-defined-ai-act\">C(2025) 884<\/a> <\/strong><\/span>&#8211; \u898f\u5247\uff08EU\uff092024\/1689\uff08AI\u6cd5\uff09\u306b\u3088\u3063\u3066\u78ba\u7acb\u3055\u308c\u305f\u7981\u6b62\u3055\u308c\u305f\u4eba\u5de5\u77e5\u80fd\u306e\u5b9f\u8df5\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3002<\/li><li>\u65b0\u3057\u3044\u6b27\u5dde\u59d4\u54e1\u4f1a\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/digital-strategy.ec.europa.eu\/en\/library\/commission-publishes-guidelines-ai-system-definition-facilitate-first-ai-acts-rules-application\">C(2025) 924<\/a> <\/strong><\/span>&#8211; \u898f\u5247\uff08EU\uff092024\/1689\uff08AI\u6cd5\uff09\u306b\u3088\u3063\u3066\u78ba\u7acb\u3055\u308c\u305f\u4eba\u5de5\u77e5\u80fd\u30b7\u30b9\u30c6\u30e0\u306e\u5b9a\u7fa9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/li><li> <\/li><\/ul><p><strong>2025\u5e741\u6708\uff1a<\/strong><\/p><ul><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<strong><span style=\"text-decoration: underline;\"> <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf\">MDCG 2023-3 rev.2<\/a> &#8211;<\/span><\/strong> \u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5247\uff08EU\uff092017\/745\u304a\u3088\u3073\u898f\u5247\uff08EU\uff092017\/746\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u8b66\u6212\u7528\u8a9e\u3068\u6982\u5ff5\u306b\u95a2\u3059\u308b<em>\u8cea\u554f\u3068\u56de\u7b54<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/939cc0b8-8db5-4b0d-b2b7-a15a98a44cbd_en?filename=mdcg_2024-7_en_0.docx\"><span style=\"text-decoration: underline;\">MDCG 2024-7 rev.1<\/span><\/a> &#8211;<\/strong> <em>\u4e88\u5099\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/em><em>\u2013<\/em><em>MDR\uff08\u898f\u5247\uff08EU\uff092017\/745\uff09<\/em>&#038;<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ec243aca-cca6-4b38-bf3b-ce22396ccc0f_en?filename=mdcg_2021-15_and_2024-7_annex_en.docx\">MDCG 2021-15\/MDCG 2024-7 Annex<\/a> <\/strong><\/span>&#8211; <em>\u7533\u8acb\u66f8\u304a\u3088\u3073PAR\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8MDR\uff08\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u30ea\u30b9\u30c8\uff09\u3078\u306e\u9644\u5c5e\u66f8<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong> <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/9819fd07-3281-477b-a8c6-22c0c47c47a6_en?filename=mdcg_2024-8_en_0.docx\">MDCG 2024-8 rev.1<\/a><\/strong><\/span><em> &#8211; \u4e88\u5099\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/em><em>\u2013<\/em><em>IVDR\uff08\u898f\u5247\uff08EU\uff092017\/746\uff09<\/em>&#038; <span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/14dd6ea0-3572-4056-984f-911e9a87fae8_en?filename=mdcg_2021-16_and_2024-8_annex_en.docx\">MDCG 2021-16\/MDCG 2024-8 Annex<\/a><\/strong><\/span> &#8211; <em>\u7533\u8acb\u66f8\u304a\u3088\u3073PAR\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8IVDR\uff08\u30c9\u30ad\u30e5\u30e1\u30f3\u30c8\u306e\u30ea\u30b9\u30c8\uff09\u3078\u306e\u9644\u5c5e\u66f8<\/em>\u3002<\/li><li>MDR &#038; IVDR\u306e<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c28e965a-3b7c-4a5b-a6ee-d1724d06f20d_en?filename=md_contact_points_of_national_authorities.pdf\">Contact Points of National Authorities<\/a><\/strong><\/span>\u3092\u66f4\u65b0\u3057\u307e\u3057\u305f\uff1a<\/li><li>\u65b0\u3057\u3044MedTech Europe Public Report\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/www.medtecheurope.org\/resource-library\/medtech-europe-2024-regulatory-survey-key-findings-and-insights\/\"><em>MedTech Europe IVDR &#038; MDR Survey Results 202<\/em>4<\/a>.<\/strong><\/span><\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/d90b3f63-1d62-43e6-bf5f-fb32ea7c47a2_en?filename=md_2021-12_en.pdf\">MDCG 2021-12 rev.1<\/a><\/strong><\/span> &#8211; <em>FAQ<\/em><em>on the European Medical Device Nomenclature (EMDN)<\/em>\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ff8d6bf6-785f-48e1-beaf-2cfe13f59fd7_en?filename=mdcg_2025-2_en.pdf\">MDCG 2025-2<\/a> &#8211;<\/strong><\/span> <em>Summary of EMDN 2024 Submissions and outcome of annual revisi\u00f3n<\/em>\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/4467c367-be73-4673-aa68-b532222d6bf2_en?filename=mdcg_2025-3_en.xlsx\">MDCG 2025-3 &#8211;<\/a><\/strong><\/span> <em>Summary of EMDN 2024 Submissions and outcome of annual revision.<\/em><\/li><li>\u65b0\u3057\u3044MedTech Europe Public Report\uff1a<em>MedTech Europe IVDR &#038; MDR Survey Results 202<\/em>4<\/li><li>\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u306e\u533b\u7642\u6a5f\u5668\u5c02\u9580\u5bb6\u30d1\u30cd\u30eb\u304b\u3089\u306e\u65b0\u3057\u3044\u79d1\u5b66\u7684\u30a2\u30c9\u30d0\u30a4\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/advice-sars-cov-2-request-medical-device-coordination-group-29-january-2025-2025-01-29_en\">EMA\/EX\/0000221902\/2024<\/a> <\/strong><\/span>&#8211; <em>Advice on SARS-CoV-2 on request from the Medical Device Coordination Group<\/em>\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-6182ffa9 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6182ffa9\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-57ebd965\" data-id=\"57ebd965\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f6307f7 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"f6307f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h2><span style=\"color: #f08200;\"><strong>2024\u5e74\u898f\u5236\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8<\/strong><\/span><\/h2>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1c3514d elementor-widget elementor-widget-n-accordion\" data-id=\"1c3514d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;expanded&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2950\" class=\"e-n-accordion-item\" open>\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"true\" aria-controls=\"e-n-accordion-item-2950\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e7412\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2950\" class=\"elementor-element elementor-element-a3a4400 e-con-full e-flex e-con e-child\" data-id=\"a3a4400\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2950\" class=\"elementor-element elementor-element-e84028f e-flex e-con-boxed e-con e-child\" data-id=\"e84028f\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3fb57e7 elementor-widget elementor-widget-text-editor\" data-id=\"3fb57e7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ebbc4f6a-4945-4d5d-9c22-9bc1aafc5532_en?filename=mdcg_2022-3_en.pdf\">MDCG 2022-3 rev.1<\/a> <\/strong><\/span>&#8211; <em>Verification of manufactured class D IVDs by notified bodies<\/em>\u3002<\/li><li>\u65b0\u3057\u3044Team NB position paper &#8211; <em>MDR Certification Process (including Pre-application, Application and Post Application phases) \u2013 Consensus document<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/36268741-3591-4130-ad21-b09487ff2074_en?filename=md_mdcg_2019_13_sampling_mdr_ivdr_en.pdf\">MDCG 2019-13 rev.1<\/a><\/strong><\/span> &#8211; <em>Guidance on sampling of devices for the assessment of the technical documentation<\/em>\u3002<\/li><li>\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073in vitro\u8a3a\u65ad\u306b\u95a2\u3059\u308bEU\u898f\u5247\u2013\u6b27\u5dde\u59d4\u54e1\u4f1a\u306b\u3088\u308b\u5bfe\u8c61\u3092\u7d5e\u3063\u305f\u8a55\u4fa1\u306e\u305f\u3081\u306e\u8a3c\u62e0\u306e\u52df\u96c6\u3002<\/li><li>\u6b27\u5dde\u59d4\u54e1\u4f1a\u304b\u3089\u306e\u66f4\u65b0\u3055\u308c\u305fQ&#038;A <em>&#8211; The information obligation in case of interruption or discontinuation of supply of certain medical devices and in vitro diagnostic medical devices<\/em>\u3002<\/li><li>\u6b27\u5dde\u8b70\u4f1a\u304a\u3088\u3073\u7406\u4e8b\u4f1a\u3078\u306e\u59d4\u54e1\u4f1a\u304b\u3089\u306e\u5831\u544a\u66f8<em> the operation of Article 17 of Regulation (EU) 2017\/745 of the European Parliament and of the Council on single-use devices and their reprocessing.<\/em><\/li><li>Team-NB High level position on <em>the regulatory framework for the medical devices sector.<\/em><\/li><li>\u65b0\u3057\u3044MedTech Eruope position paper\uff1a<em>Smooth transition to the mandatory use of EUDAMED Perspectives from manufacturers<\/em>\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2024-16-manufacturer-information-form-interruption-or-discontinuation-supply-certain-medical-2024-12-06_en\">MDCG 2024-16<\/a><\/strong><\/span> &#8211; <em>Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices<\/em><\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/0e076d19-62dc-4ff9-83f2-be6072a45993_en?filename=mdcg_2024-15_en.pdf\">MDCG 2024-15<\/a> <\/strong><\/span>&#8211; <em>Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.<\/em><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2951\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2951\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e7411\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2951\" class=\"elementor-element elementor-element-fdb3088 e-con-full e-flex e-con e-child\" data-id=\"fdb3088\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2951\" class=\"elementor-element elementor-element-968a5da e-flex e-con-boxed e-con e-child\" data-id=\"968a5da\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-698d18e elementor-widget elementor-widget-text-editor\" data-id=\"698d18e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf\">MDCG 2023-3 Rev. 1<\/a><\/strong><\/span> \u898f\u5247\uff08EU\uff092017\/745\u304a\u3088\u3073\u898f\u5247\uff08EU\uff092017\/746\u306b\u6982\u8aac\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u8b66\u6212\u7528\u8a9e\u3068\u6982\u5ff5\u306b\u95a2\u3059\u308b\u8cea\u554f\u3068\u56de\u7b54<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/c8c6cca5-460e-410e-a325-be08bfc7dea6_en?filename=mdcg_2024-14_en.pdf\">MDCG 2024-14<\/a><\/strong><\/span> &#8211; <em>Guidance on the implementation of the Master UDI-DI solution for contact lenses<\/em>\u3002<\/li><li>\u65b0\u3057\u3044Q&#038;A\uff1a<em>Gradual roll out of EUDAMED &#8211; Q&#038;As on practical aspects related to the implementation of Regulation (EU) 2024\/1860<\/em> <span style=\"text-decoration: underline;\"><strong>(<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/0e7327c7-0e06-4fbd-90d3-8ab7bb30fe9f_en?filename=md_mdcg_2024-11_eudamed-qa.pdf\">Gradual roll out of EUDAMED<\/a>)<\/strong><\/span>\u3002<\/li><li>\u65b0\u3057\u3044Team-NB position paper\uff1a<em>Artificial Intelligence In Medical Devices \u2013 Questionnaire <\/em>(<a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/2025\/02\/Joint-Team-NB-IG-NB-PositionPaper-AI-in-MD-Questionnaire-V1-20241125.pdf\" target=\"_blank\" rel=\"noopener\"><span style=\"text-decoration: underline;\"><strong>Team-NB AI in MDs<\/strong><\/span><\/a>)\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2952\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2952\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e7410\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2952\" class=\"elementor-element elementor-element-e15fbb7 e-con-full e-flex e-con e-child\" data-id=\"e15fbb7\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2952\" class=\"elementor-element elementor-element-9b1addd e-flex e-con-boxed e-con e-child\" data-id=\"9b1addd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-b9659df elementor-widget elementor-widget-text-editor\" data-id=\"b9659df\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12b92152-371f-404d-a865-93800cd5cdca_en?filename=mdcg_2024-11_en.pdf\">MDCG 2024-11<\/a><\/strong><\/span> &#8211; <em>Guidance on qualification of in vitro diagnostic medical devices<\/em>\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/080c6aed-4f09-4a8a-b052-3414275945db_en?filename=mdcg_2024-12_en.pdf\">MDCG 2024-12<\/a><\/strong><\/span> &#8211; <em>Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/cbb11a6e-f0f3-4e30-af5e-990f9ef68bc1_en?filename=md_mdcg_2021_25_en.pdf\">MDCG 2021-25 rev.1<\/a><\/strong><\/span> &#8211; <em>&#8220;<strong>legacy devices<\/strong>&#8220;\u304a\u3088\u3073\u6307\u4ee490\/385\/EEC\u307e\u305f\u306f93\/42\/EEC\u306b\u5f93\u3063\u30662021\u5e745\u670826\u65e5\u3088\u308a\u524d\u306b\u5e02\u5834\u306b\u51fa\u3055\u308c\u305f\u30c7\u30d0\u30a4\u30b9\u3078\u306eMDR\u8981\u4ef6\u306e\u9069\u7528<\/em>\u3002<\/li><li><span style=\"text-decoration: underline;\"><a href=\"https:\/\/www.europarl.europa.eu\/doceo\/document\/B-10-2024-0122_ES.html\"><strong>2024\/2849(RSP)<\/strong><\/a><\/span><strong>: <\/strong>\u533b\u7642\u6a5f\u5668\u898f\u5247\u306e\u7dca\u6025\u306e\u6539\u8a02\u306e\u5fc5\u8981\u6027\u306b\u95a2\u3059\u308b\u6b27\u5dde\u8b70\u4f1a\u306e\u6c7a\u8b70\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/3fa74c6b-953a-41f5-b024-8889ac8b5ddf_en?filename=mdcg_2024-13_en.pdf\">MDCG 2024-13<\/a> &#8211;<\/strong><\/span> \u533b\u7642\u6a5f\u5668\u306e\u6ec5\u83cc\u3092\u76ee\u7684\u3068\u3057\u305f\u30a8\u30c1\u30ec\u30f3\u30aa\u30ad\u30b7\u30c9\uff08EtO\uff09\u306e\u898f\u5236\u72b6\u6cc1\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b5a27717-229f-4d7a-97b1-e1c7d819e579_en?filename=mdcg_2022-5_en.pdf\"><span style=\"text-decoration: underline;\"><strong>MDCG 2022-5 rev.1<\/strong><\/span><\/a> &#8211; \u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u898f\u5247\uff08EU\uff092017\/745\u306b\u57fa\u3065\u304f\u533b\u7642\u6a5f\u5668\u3068\u533b\u85ac\u54c1\u306e\u9593\u306e\u5883\u754c\u7dda\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u3002<\/li><li>\u533b\u7642\u88fd\u54c1\u306e\u7121\u83cc\u51e6\u7406\u306b\u95a2\u3059\u308b\u6574\u5408\u898f\u683c\u306b\u95a2\u3059\u308b\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092021\/1182\u3092\u4fee\u6b63\u3059\u308b2024\u5e7410\u67088\u65e5\u306e\u59d4\u54e1\u4f1a\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092024\/2631<span style=\"text-decoration: underline;\"><strong> (<a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/2631\/oj\">C\/2024\/6872<\/a>)<\/strong><\/span>;<\/li><li>\u533b\u7642\u88fd\u54c1\u306e\u7121\u83cc\u51e6\u7406\u304a\u3088\u3073\u30d2\u30c8\u88ab\u9a13\u8005\u304b\u3089\u306e\u691c\u4f53\u3092\u4f7f\u7528\u3057\u305f\u81e8\u5e8a\u6027\u80fd\u8a66\u9a13\u306b\u95a2\u3059\u308b\u6574\u5408\u898f\u683c\u306b\u95a2\u3059\u308b\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092021\/1195\u3092\u4fee\u6b63\u3059\u308b2024\u5e7410\u67088\u65e5\u306e\u59d4\u54e1\u4f1a\u5b9f\u65bd\u6c7a\u5b9a\uff08EU\uff092024\/2625<span style=\"text-decoration: underline;\"><strong>(<a href=\"https:\/\/eur-lex.europa.eu\/eli\/dec_impl\/2024\/2625\/oj\">C\/2024\/6874<\/a>)<\/strong><\/span>;<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2953\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2953\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e749\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2953\" class=\"elementor-element elementor-element-5736ea4 e-flex e-con-boxed e-con e-child\" data-id=\"5736ea4\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2953\" class=\"elementor-element elementor-element-1ba3910 e-con-full e-flex e-con e-child\" data-id=\"1ba3910\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e8362f4 elementor-widget elementor-widget-text-editor\" data-id=\"e8362f4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/9f23fca0-f407-4e45-a464-2d71b575d1fe_en\"><span style=\"text-decoration: underline;\"><strong>MDCG 2021-4 Rev.1<\/strong><\/span><\/a> &#8211; \u898f\u5247\uff08EU\uff092017\/746\u306b\u5f93\u3063\u305f\u30af\u30e9\u30b9D in vitro\u8a3a\u65ad\u533b\u7642\u6a5f\u5668\u306e\u8a8d\u8a3c\u306b\u95a2\u3059\u308b\u79fb\u884c\u898f\u5b9a\u306e<em>\u30ac\u30a4\u30c0\u30f3\u30b9<\/em>\uff08\u4ee5\u524d\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u306e\u66f4\u65b0\uff09\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2954\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2954\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e747\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2954\" class=\"elementor-element elementor-element-573c7bd e-flex e-con-boxed e-con e-child\" data-id=\"573c7bd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2954\" class=\"elementor-element elementor-element-1e462a3 e-con-full e-flex e-con e-child\" data-id=\"1e462a3\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8129466 elementor-widget elementor-widget-text-editor\" data-id=\"8129466\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/12f9756a-1e0d-4aed-9783-d948553f1705_en?filename=md_mdcg_2020_guidance_classification_ivd-md_en.pdf\">MDCG 2020-16 Rev.3<\/a><\/strong><\/span>&#8211; \u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304fin vitro\u8a3a\u65ad\u533b\u7642\u6a5f\u5668\u306e\u5206\u985e\u898f\u5247\u306b\u95a2\u3059\u308b<em>\u30ac\u30a4\u30c0\u30f3\u30b9<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/59ac4cb0-f187-4ca2-814d-82c42cde5408_en?filename=md_mdcg_2021_5_en.pdf\"><span style=\"text-decoration: underline;\"><strong>MDCG 2021-5 Rev. 1<\/strong><\/span><\/a>&#8211; \u533b\u7642\u6a5f\u5668\u306e\u6a19\u6e96\u5316\u306b\u95a2\u3059\u308b<em>\u30ac\u30a4\u30c0\u30f3\u30b9<\/em>\u3002<\/li><li>\u65b0\u3057\u3044Q&#038;A\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/dfd7a1c6-f319-4682-9bac-77bef1165818_en?filename=mdr_qna-ext-ivdr.pdf\"><span style=\"text-decoration: underline;\"><strong>Q&#038;A<\/strong><\/span><\/a>\u306b\u95a2\u3059\u308b<em>\u5b9f\u7528\u7684\u306a\u5074\u9762<\/em>\u306b\u95a2\u3059\u308b\u898f\u5247\uff08EU\uff092024\/1860\u306b\u3088\u3063\u3066\u4fee\u6b63\u3055\u308c\u305f\u3088\u3046\u306b\u3001IVDR\u306b\u898f\u5b9a\u3055\u308c\u3066\u3044\u308b\u5ef6\u9577\u3055\u308c\u305f\u79fb\u884c\u671f\u9593\u306e\u5b9f\u65bd\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fQ&#038;A\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/592008f6-3456-4afb-a13a-733a87da1b00_en?filename=mdr_proposal_extension-q-n-a_1.pdf\"><span style=\"text-decoration: underline;\"><strong>Q&#038;A Rev. 2<\/strong><\/span><\/a>\uff08\u898f\u5247\uff08EU\uff092023\/607\u306e\u5b9f\u65bd\u306b\u95a2\u9023\u3059\u308b\u5b9f\u7528\u7684\u306a\u5074\u9762\u306b\u3064\u3044\u3066 &#8211; MDR\u79fb\u884c\u671f\u9593\u306e\u5ef6\u9577\u304a\u3088\u3073\u300c\u58f2\u308a\u5207\u308a\u300d\u671f\u9593\u306e\u524a\u9664\uff09<em>\u3002<\/em><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2955\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"6\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2955\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e746\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2955\" class=\"elementor-element elementor-element-76ec85b e-flex e-con-boxed e-con e-child\" data-id=\"76ec85b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2955\" class=\"elementor-element elementor-element-4e367ed e-con-full e-flex e-con e-child\" data-id=\"4e367ed\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8254226 elementor-widget elementor-widget-text-editor\" data-id=\"8254226\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u6b27\u5dde\u59d4\u54e1\u4f1a\u306e\u5b98\u5831\u306b<a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2024\/1860\/oj\"><span style=\"text-decoration: underline;\"><strong>\u898f\u5247\uff08EU\uff092024\/1860<\/strong><\/span><\/a>\uff08Eudamed\u306e\u6bb5\u968e\u7684\u5c0e\u5165\u3001\u4f9b\u7d66\u306e\u4e2d\u65ad\u307e\u305f\u306f\u4e2d\u6b62\u306e\u5834\u5408\u306b\u901a\u77e5\u3059\u308b\u7fa9\u52d9\u3001\u304a\u3088\u3073\u7279\u5b9a\u306e\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u79fb\u884c\u898f\u5b9a\u306b\u95a2\u3057\u3066\u3001\u898f\u5247\uff08EU\uff092017\/745\u304a\u3088\u3073\uff08EU\uff092017\/746\u3092\u6539\u6b63\u3059\u308b2024\u5e746\u670813\u65e5\u306e\u6b27\u5dde\u8b70\u4f1a\u304a\u3088\u3073\u7406\u4e8b\u4f1a\uff09\u304c\u63b2\u8f09\u3055\u308c\u307e\u3057\u305f\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/daa1fc59-9d2c-4e82-878e-d6fdf12ecd1a_en?filename=mdcg_2024-10_en.pdf\"><span style=\"text-decoration: underline;\"><strong>MDCG 2024-10<\/strong><\/span><\/a> &#8211; <em>\u30aa\u30fc\u30d5\u30a1\u30f3\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a55\u4fa1<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/27f91dc2-b5bc-44f9-a975-5024ce3ea556_en?filename=mdcg_2022-13_en.pdf\">MDCG 2022-13 Rev.1<\/a><\/strong><\/span> &#8211; <em>\u9069\u5408\u6027\u8a55\u4fa1\u6a5f\u95a2\u304a\u3088\u3073\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30dc\u30c7\u30a3\u306e\u6307\u5b9a\u3001\u518d\u8a55\u4fa1\u3001\u304a\u3088\u3073\u901a\u77e5\u3002<\/em><\/li><li>\u66f4\u65b0\u3055\u308c\u305f<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/831f9b60-88de-4197-858f-d001c5b0cc26_en?filename=mdcg_scheer_o_064.pdf\">SCHEER\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3<\/a><\/strong><\/span>\uff08\u7279\u5b9a\u306e\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u30d5\u30bf\u30eb\u9178\u30a8\u30b9\u30c6\u30eb\u306e\u5b58\u5728\u306e\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u8a55\u4fa1\u306b\u3064\u3044\u3066<em>\u3001\u767a\u304c\u3093\u6027\u3001\u5909\u7570\u539f\u6027\u3001\u751f\u6b96\u6bd2\u6027\uff08CMR\uff09\u307e\u305f\u306f\u5185\u5206\u6ccc\u304b\u304f\u4e71\u6027\uff08ED\uff09\u7279\u6027\u3092\u6709\u3059\u308b\u30d5\u30bf\u30eb\u9178\u30a8\u30b9\u30c6\u30eb\u3092\u5bfe\u8c61\u3068\u3059\u308b<\/em>\uff09<\/li><\/ul><p><strong> <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2956\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"7\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2956\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e745\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2956\" class=\"elementor-element elementor-element-5081c60 e-flex e-con-boxed e-con e-child\" data-id=\"5081c60\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2956\" class=\"elementor-element elementor-element-74f8904 e-con-full e-flex e-con e-child\" data-id=\"74f8904\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2c64ab7 elementor-widget elementor-widget-text-editor\" data-id=\"2c64ab7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/88772d4f-9e29-4b1b-aa41-adcc74b6bb41_en?filename=mdcg_2024-6_en_0.docx\">MDCG 2024-6<\/a> &#8211;<\/strong><\/span> <em>\u4e88\u5099\u7684\u518d\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\uff08PRAR\uff09\u30d5\u30a9\u30fc\u30e0\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08MDR\uff09<\/em><\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/939cc0b8-8db5-4b0d-b2b7-a15a98a44cbd_en?filename=mdcg_2024-7_en_0.docx\">MDCG 2024-7<\/a> &#8211;<\/strong><\/span> <em>\u4e88\u5099\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\uff08PAR\uff09\u30d5\u30a9\u30fc\u30e0\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08MDR\uff09<\/em> <\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/9819fd07-3281-477b-a8c6-22c0c47c47a6_en?filename=mdcg_2024-8_en_0.docx\">MDCG 2024-8<\/a> &#8211;<\/strong><\/span> <em>\u4e88\u5099\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\uff08PAR\uff09\u30d5\u30a9\u30fc\u30e0\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08IVDR\uff09<\/em><\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/f067a42e-4af6-47dd-980f-b251eeeafaf0_en?filename=mdcg_2024-9_en_0.docx\">MDCG 2024-9<\/a> &#8211;<\/strong><\/span> <em>\u4e88\u5099\u7684\u518d\u8a55\u4fa1\u30ec\u30d3\u30e5\u30fc\uff08PRAR\uff09\u30d5\u30a9\u30fc\u30e0\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8\uff08IVDR\uff09<\/em><\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/e5714b2b-e98b-4fce-b5ff-d9141a8f30e1_en?filename=mdcg_2022-4_en.pdf\"><span style=\"text-decoration: underline;\"><strong>MDCG 2022-4 rev.2<\/strong><\/span><\/a> &#8211; <em>MDD\u307e\u305f\u306fAIMDD\u306b\u57fa\u3065\u304f\u8a3c\u660e\u66f8\u306e\u5bfe\u8c61\u3068\u306a\u308b\u6a5f\u5668\u306b\u95a2\u3059\u308bMDR\u7b2c120\u6761\u306b\u57fa\u3065\u304f\u79fb\u884c\u898f\u5b9a\u306b\u95a2\u3059\u308b\u9069\u5207\u306a\u30b5\u30fc\u30d9\u30a4\u30e9\u30f3\u30b9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/em><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2957\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"8\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2957\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e744\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2957\" class=\"elementor-element elementor-element-11e26fc e-flex e-con-boxed e-con e-child\" data-id=\"11e26fc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2957\" class=\"elementor-element elementor-element-c5a1b33 e-con-full e-flex e-con e-child\" data-id=\"c5a1b33\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-273e27b elementor-widget elementor-widget-text-editor\" data-id=\"273e27b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/5cc894e0-331d-4fa2-8ab3-cdd4437c48fc_en?filename=mdcg_2024-4_en.pdf\">MDCG 2024-4<\/a>&#8211;<\/strong><\/span> <em>\u898f\u5247\uff08EU\uff092017\/746\u306b\u57fa\u3065\u304f\u4f53\u5916\u8a3a\u65ad\u7528\u533b\u7642\u6a5f\u5668\u306e\u6027\u80fd\u8a66\u9a13\u306b\u304a\u3051\u308b\u5b89\u5168\u6027\u5831\u544a<\/em>\u3002<\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/ee7ee8eb-841a-4085-a8dc-af6d55ebf1bd_en?filename=mdcg_2024-5_en.pdf\">MDCG 2024-5<\/a> &#8211;<\/strong><\/span> <em>\u6cbb\u9a13\u8005\u7528\u30d1\u30f3\u30d5\u30ec\u30c3\u30c8\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/em>\u3002<\/li><li>\u66f4\u65b0\u3055\u308c\u305fMDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b7cf356f-733f-4dce-9800-0933ff73622a_en?filename=mdcg_2022-9_en.pdf\"><span style=\"text-decoration: underline;\"><strong>MDCG 2022-9 Rev.1<\/strong><\/span><\/a>&#8211; <em>\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u306e\u6982\u8981\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/em>\u3002<\/li><\/ul><p><strong> <\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2958\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"9\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2958\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e743\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2958\" class=\"elementor-element elementor-element-47269d2 e-flex e-con-boxed e-con e-child\" data-id=\"47269d2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2958\" class=\"elementor-element elementor-element-ad30163 e-con-full e-flex e-con e-child\" data-id=\"ad30163\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d78d898 elementor-widget elementor-widget-text-editor\" data-id=\"d78d898\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf\">MDCG 2024-3<\/a> &#8211;<\/strong><\/span> <em>\u533b\u7642\u6a5f\u5668\u306e\u81e8\u5e8a\u8a66\u9a13\u306e\u305f\u3081\u306e\u81e8\u5e8a\u8a66\u9a13\u8a08\u753b\u66f8\u306e\u5185\u5bb9\u306b\u95a2\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9<\/em>\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-2959\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"10\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-2959\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e742\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2959\" class=\"elementor-element elementor-element-d9bea10 e-flex e-con-boxed e-con e-child\" data-id=\"d9bea10\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-2959\" class=\"elementor-element elementor-element-e75e9f6 e-con-full e-flex e-con e-child\" data-id=\"e75e9f6\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0319eb4 elementor-widget elementor-widget-text-editor\" data-id=\"0319eb4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/de470384-e8be-45e7-a334-226757f8816d_en?filename=mdcg_2024-2_en.pdf\">MDCG 2024-2<\/a> &#8211;<\/strong><\/span> <em>EMDN\u306e\u66f4\u65b0\u624b\u9806<\/em>\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-29510\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"11\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-29510\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> 2024\u5e741\u6708 <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"fas fa-minus\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"fas fa-plus\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-29510\" class=\"elementor-element elementor-element-d1b1462 e-flex e-con-boxed e-con e-child\" data-id=\"d1b1462\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-29510\" class=\"elementor-element elementor-element-1978f41 e-con-full e-flex e-con e-child\" data-id=\"1978f41\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f2a8530 elementor-widget elementor-widget-text-editor\" data-id=\"f2a8530\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li>\u7279\u5b9a\u306eIVD\u306e\u79fb\u884c\u671f\u9593\u3001Eudamed\u306e\u6bb5\u968e\u7684\u5c0e\u5165\u3001\u304a\u3088\u3073\u4f9b\u7d66\u306e\u4e2d\u65ad\u306e\u5834\u5408\u306e\u60c5\u5831\u7fa9\u52d9\u3092\u5ef6\u9577\u3059\u308b\u305f\u3081\u306e<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/commission-proposes-extend-transition-periods-certain-ivds-gradual-roll-out-eudamed-and-information-2024-01-23_en\"><span style=\"text-decoration: underline;\"><strong>\u6b27\u5dde\u59d4\u54e1\u4f1a\u63d0\u6848<\/strong><\/span><\/a>\u3002<\/li><li><span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/publications\/overview-language-requirements-manufacturers-medical-devices_en\">MDR\/IVDR\u306e\u8a00\u8a9e\u8981\u4ef6<\/a><\/strong><\/span>\u306b\u95a2\u3059\u308b\u516c\u958b &#8211; \u7279\u5b9a\u306e\u56fd\u3067\u6a5f\u5668\u306b\u6dfb\u4ed8\u3055\u308c\u308b\u60c5\u5831\u304a\u3088\u3073\u6307\u793a\u306b\u95a2\u3059\u308b<em>\u533b\u7642\u6a5f\u5668\u30e1\u30fc\u30ab\u30fc\u5411\u3051\u306e\u8a00\u8a9e\u8981\u4ef6\u306e\u6982\u8981<\/em><em>\u3002<\/em><\/li><li>\u65b0\u3057\u3044MDCG\u30ac\u30a4\u30c0\u30f3\u30b9\uff1a<span style=\"text-decoration: underline;\"><strong><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/dbd0d748-d646-4274-afaa-399952809389_en?filename=mdcg_2024-1_en.pdf\">MDCG 2024-1<\/a><\/strong><\/span> &#8211; <em>\u6a5f\u5668\u56fa\u6709\u306e\u5e02\u8ca9\u5f8c\u5b89\u5168\u5bfe\u7b56\u30ac\u30a4\u30c0\u30f3\u30b9\uff08DSVG\uff09\u30c6\u30f3\u30d7\u30ec\u30fc\u30c8<\/em>\u3002<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4dbb870f elementor-section-height-default elementor-section-boxed elementor-section-height-default\" data-id=\"4dbb870f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-wide\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-inner-column elementor-element elementor-element-29178ad4\" data-id=\"29178ad4\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-508d07bb elementor-widget elementor-widget-heading\" data-id=\"508d07bb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u95a2\u9023\u30ea\u30bd\u30fc\u30b9<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-21d41275 uael-posts-thumbnail-ratio uael-post__arrow-outside elementor-widget elementor-widget-uael-posts\" data-id=\"21d41275\" data-element_type=\"widget\" data-e-type=\"widget\" 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class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/mdr%e6%8a%80%e8%a1%93%e6%96%87%e6%9b%b8%e9%99%84%e5%b1%9e%e6%9b%b8ii%e3%81%8a%e3%82%88%e3%81%b3iii%e3%81%ae%e6%a7%8b%e6%88%90%e6%96%b9%e6%b3%95-%e5%ae%9f%e8%b7%b5%e7%9a%84%e3%82%b3%e3%83%b3\/\" target=\"_self\" title=\"MDR\u6280\u8853\u6587\u66f8(\u9644\u5c5e\u66f8II\u304a\u3088\u3073III)\u306e\u69cb\u6210\u65b9\u6cd5 &#8211; \u5b9f\u8df5\u7684\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ac\u30a4\u30c9\"><img decoding=\"async\" width=\"768\" height=\"495\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-768x495.png\" class=\"attachment-medium_large size-medium_large wp-image-48634\" alt=\"Banner Resource Hub Web\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-768x495.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-300x193.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-1024x660.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-1536x991.png 1536w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/03\/Banner-Resource-Hub-Web-2048x1321.png 2048w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">\u30ac\u30a4\u30c9<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/mdr%e6%8a%80%e8%a1%93%e6%96%87%e6%9b%b8%e9%99%84%e5%b1%9e%e6%9b%b8ii%e3%81%8a%e3%82%88%e3%81%b3iii%e3%81%ae%e6%a7%8b%e6%88%90%e6%96%b9%e6%b3%95-%e5%ae%9f%e8%b7%b5%e7%9a%84%e3%82%b3%e3%83%b3\/\" target=\"_self\">\n\t\t\t\tMDR\u6280\u8853\u6587\u66f8(\u9644\u5c5e\u66f8II\u304a\u3088\u3073III)\u306e\u69cb\u6210\u65b9\u6cd5 &#8211; \u5b9f\u8df5\u7684\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30ac\u30a4\u30c9\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\t\u672c\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u306f\u3001\u9644\u5c5e\u66f8II\u304a\u3088\u3073\u9644\u5c5e\u66f8III ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/mdr%e6%8a%80%e8%a1%93%e6%96%87%e6%9b%b8%e9%99%84%e5%b1%9e%e6%9b%b8ii%e3%81%8a%e3%82%88%e3%81%b3iii%e3%81%ae%e6%a7%8b%e6%88%90%e6%96%b9%e6%b3%95-%e5%ae%9f%e8%b7%b5%e7%9a%84%e3%82%b3%e3%83%b3\/\" target=\"_self\" aria-labelledby=\"uael-post-48851\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-48851>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e3%82%b0%e3%83%ad%e3%83%bc%e3%83%90%e3%83%ab%e5%8c%96%e7%b2%a7%e5%93%81%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc%e3%81%aegmp%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9-2\/\" target=\"_self\" title=\"\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08MDSW\uff09\u306e\u691c\u8a3c\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u652f\u63f4\"><img decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/07\/Ensuring-Compliance-and-Data-Integrity-in-Pharmacovigilan-768x432.png\" class=\"attachment-medium_large size-medium_large wp-image-48422\" alt=\"\u30d5\u30a1\u30fc\u30de\u30b3\u30d3\u30b8\u30e9\u30f3\u30b9\u306b\u304a\u3051\u308b\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3068\u30c7\u30fc\u30bf\u30a4\u30f3\u30c6\u30b0\u30ea\u30c6\u30a3\u306e\u78ba\u4fdd\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/07\/Ensuring-Compliance-and-Data-Integrity-in-Pharmacovigilan-768x432.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/07\/Ensuring-Compliance-and-Data-Integrity-in-Pharmacovigilan-300x169.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/07\/Ensuring-Compliance-and-Data-Integrity-in-Pharmacovigilan-1024x576.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/07\/Ensuring-Compliance-and-Data-Integrity-in-Pharmacovigilan.png 1500w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">\u30b1\u30fc\u30b9\u30b9\u30bf\u30c7\u30a3<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e3%82%b0%e3%83%ad%e3%83%bc%e3%83%90%e3%83%ab%e5%8c%96%e7%b2%a7%e5%93%81%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc%e3%81%aegmp%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9-2\/\" target=\"_self\">\n\t\t\t\t\u533b\u7642\u6a5f\u5668\u30bd\u30d5\u30c8\u30a6\u30a7\u30a2\uff08MDSW\uff09\u306e\u691c\u8a3c\u304a\u3088\u3073\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\u306e\u652f\u63f4\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\t\u3042\u308b\u533b\u7642\u6a5f\u5668\u30b9\u30bf\u30fc\u30c8\u30a2\u30c3\u30d7\u4f01\u696d\u304c\u3001MDR\u306e\u8981\u4ef6\u306b\u6cbf ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e3%82%b0%e3%83%ad%e3%83%bc%e3%83%90%e3%83%ab%e5%8c%96%e7%b2%a7%e5%93%81%e3%83%a1%e3%83%bc%e3%82%ab%e3%83%bc%e3%81%aegmp%e3%82%b3%e3%83%b3%e3%83%97%e3%83%a9%e3%82%a4%e3%82%a2%e3%83%b3%e3%82%b9-2\/\" target=\"_self\" aria-labelledby=\"uael-post-48416\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-48416>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/eu-mdr-ivdr%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%b8%82%e8%b2%a9%e5%be%8c%e7%9b%a3%e8%a6%96%ef%bc%88pms%ef%bc%89%e5%ae%9f%e5%8b%99%e3%82%ac%e3%82%a4%e3%83%89\/\" target=\"_self\" title=\"EU MDR\/IVDR\u306b\u304a\u3051\u308b\u5e02\u8ca9\u5f8c\u76e3\u8996\uff08PMS\uff09\u5b9f\u52d9\u30ac\u30a4\u30c9\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"495\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR-768x495.png\" class=\"attachment-medium_large size-medium_large wp-image-41230\" alt=\"\u30d0\u30ca\u30fc\uff1aEU MDR\/IVDR\u306b\u304a\u3051\u308b\u5e02\u8ca9\u5f8c\u76e3\u8996\uff08PMS\uff09\u5b9f\u52d9\u30ac\u30a4\u30c9\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR-768x495.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR-300x193.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR-1024x660.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR-1536x990.png 1536w, https:\/\/www.rephine.com\/wp-content\/uploads\/2026\/02\/BANNER-Practical-Guide-to-Post-Market-Surveillance-PMS-under-EU-MDR-IVDR.png 1720w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">\u30ac\u30a4\u30c9<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/eu-mdr-ivdr%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%b8%82%e8%b2%a9%e5%be%8c%e7%9b%a3%e8%a6%96%ef%bc%88pms%ef%bc%89%e5%ae%9f%e5%8b%99%e3%82%ac%e3%82%a4%e3%83%89\/\" target=\"_self\">\n\t\t\t\tEU MDR\/IVDR\u306b\u304a\u3051\u308b\u5e02\u8ca9\u5f8c\u76e3\u8996\uff08PMS\uff09\u5b9f\u52d9\u30ac\u30a4\u30c9\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tEU\u306e\u65b0\u3057\u3044\u88fd\u9020\u7269\u8cac\u4efb\u6307\u4ee4\uff082024\/2853\uff09\u306f ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/eu-mdr-ivdr%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e5%b8%82%e8%b2%a9%e5%be%8c%e7%9b%a3%e8%a6%96%ef%bc%88pms%ef%bc%89%e5%ae%9f%e5%8b%99%e3%82%ac%e3%82%a4%e3%83%89\/\" target=\"_self\" aria-labelledby=\"uael-post-41229\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-41229>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e6%96%b0%e3%81%97%e3%81%84eu%e8%a3%bd%e9%80%a0%e7%89%a9%e8%b2%ac%e4%bb%bb%e6%8c%87%e4%bb%a4%e3%81%ab%e3%80%81%e5%be%a1%e7%a4%be%e3%81%ae%e4%bf%9d%e9%99%ba%e5%a5%91%e7%b4%84%e3%81%af%e5%af%be%e5%bf%9c\/\" target=\"_self\">\n\t\t\t\t\u65b0\u3057\u3044EU\u88fd\u9020\u7269\u8cac\u4efb\u6307\u4ee4\u306b\u3001\u5fa1\u793e\u306e\u4fdd\u967a\u5951\u7d04\u306f\u5bfe\u5fdc\u3067\u304d\u3066\u3044\u307e\u3059\u304b\uff1f\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tEU\u306e\u65b0\u3057\u3044\u88fd\u9020\u7269\u8cac\u4efb\u6307\u4ee4\uff082024\/2853\uff09\u306f ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e6%96%b0%e3%81%97%e3%81%84eu%e8%a3%bd%e9%80%a0%e7%89%a9%e8%b2%ac%e4%bb%bb%e6%8c%87%e4%bb%a4%e3%81%ab%e3%80%81%e5%be%a1%e7%a4%be%e3%81%ae%e4%bf%9d%e9%99%ba%e5%a5%91%e7%b4%84%e3%81%af%e5%af%be%e5%bf%9c\/\" target=\"_self\" aria-labelledby=\"uael-post-24345\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-24345>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%83%96%e3%83%ad%e3%82%b0\/%e8%a3%bd%e8%96%ac%e6%a5%ad%e7%95%8c%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%83%87%e3%83%bc%e3%82%bf%e3%82%ac%e3%83%90%e3%83%8a%e3%83%b3%e3%82%b9%e3%81%a8ai-%e4%bf%a1%e9%a0%bc%e3%81%a8%e3%82%b3\/\" target=\"_self\">\n\t\t\t\t\u88fd\u85ac\u696d\u754c\u306b\u304a\u3051\u308b\u30c7\u30fc\u30bf\u30ac\u30d0\u30ca\u30f3\u30b9\u3068AI | \u4fe1\u983c\u3068\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u78ba\u4fdd\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tAI\u304c\u88fd\u85ac\u696d\u754c\u5168\u4f53\u306b\u5909\u9769\u3092\u3082\u305f\u3089\u3059\u3068\u671f\u5f85\u3055\u308c\u308b\u6642\u4ee3 ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%83%96%e3%83%ad%e3%82%b0\/%e8%a3%bd%e8%96%ac%e6%a5%ad%e7%95%8c%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e3%83%87%e3%83%bc%e3%82%bf%e3%82%ac%e3%83%90%e3%83%8a%e3%83%b3%e3%82%b9%e3%81%a8ai-%e4%bf%a1%e9%a0%bc%e3%81%a8%e3%82%b3\/\" target=\"_self\" aria-labelledby=\"uael-post-27220\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-27220>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e8%a3%bd%e9%80%a0%e3%83%97%e3%83%ad%e3%82%bb%e3%82%b9%e3%83%90%e3%83%aa%e3%83%87%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3\/\" target=\"_self\" title=\"\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Medical-Device-768x432.png\" class=\"attachment-medium_large size-medium_large wp-image-49010\" alt=\"\u533b\u7642\u6a5f\u5668\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Medical-Device-768x432.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Medical-Device-300x169.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Medical-Device-1024x576.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Medical-Device.png 1500w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">\u30ac\u30a4\u30c9<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e8%a3%bd%e9%80%a0%e3%83%97%e3%83%ad%e3%82%bb%e3%82%b9%e3%83%90%e3%83%aa%e3%83%87%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3\/\" target=\"_self\">\n\t\t\t\t\u533b\u7642\u6a5f\u5668\u306e\u88fd\u9020\u30d7\u30ed\u30bb\u30b9\u30d0\u30ea\u30c7\u30fc\u30b7\u30e7\u30f3\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\t\u672c\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\u3067\u306f\u3001ISO 13485\u304a\u3088\u3073I ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e8%a3%bd%e9%80%a0%e3%83%97%e3%83%ad%e3%82%bb%e3%82%b9%e3%83%90%e3%83%aa%e3%83%87%e3%83%bc%e3%82%b7%e3%83%a7%e3%83%b3\/\" target=\"_self\" aria-labelledby=\"uael-post-26610\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-26610>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e5%8c%bb%e8%96%ac%e5%93%81%e8%a3%bd%e9%80%a0%e8%a3%85%e7%bd%ae%e3%81%ae%e5%86%8d%e9%81%a9%e6%a0%bc%e6%80%a7%e8%a9%95%e4%be%a1%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e4%ba%8b%e4%be%8b%e7%a0%94%e7%a9%b6\/\" target=\"_self\" title=\"\u533b\u85ac\u54c1\u88fd\u9020\u88c5\u7f6e\u306e\u518d\u9069\u683c\u6027\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u4e8b\u4f8b\u7814\u7a76\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"432\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Pharma-equipment-qualification-hero-image-768x432.png\" class=\"attachment-medium_large size-medium_large wp-image-26726\" alt=\"\u533b\u85ac\u54c1\u8a2d\u5099\u9069\u683c\u6027\u8a55\u4fa1\u306e\u30d2\u30fc\u30ed\u30fc\u753b\u50cf\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Pharma-equipment-qualification-hero-image-768x432.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Pharma-equipment-qualification-hero-image-300x169.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Pharma-equipment-qualification-hero-image-1024x576.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/06\/Pharma-equipment-qualification-hero-image.png 1500w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">CSV<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e5%8c%bb%e8%96%ac%e5%93%81%e8%a3%bd%e9%80%a0%e8%a3%85%e7%bd%ae%e3%81%ae%e5%86%8d%e9%81%a9%e6%a0%bc%e6%80%a7%e8%a9%95%e4%be%a1%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e4%ba%8b%e4%be%8b%e7%a0%94%e7%a9%b6\/\" target=\"_self\">\n\t\t\t\t\u533b\u85ac\u54c1\u88fd\u9020\u88c5\u7f6e\u306e\u518d\u9069\u683c\u6027\u8a55\u4fa1\u306b\u95a2\u3059\u308b\u4e8b\u4f8b\u7814\u7a76\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tRephine\u304c\u3001\u30b0\u30ed\u30fc\u30d0\u30eb\u88fd\u85ac\u4f01\u696d\u304cAnnex  ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%b1%e3%83%bc%e3%82%b9%e3%82%b9%e3%82%bf%e3%83%87%e3%82%a3\/%e5%8c%bb%e8%96%ac%e5%93%81%e8%a3%bd%e9%80%a0%e8%a3%85%e7%bd%ae%e3%81%ae%e5%86%8d%e9%81%a9%e6%a0%bc%e6%80%a7%e8%a9%95%e4%be%a1%e3%81%ab%e9%96%a2%e3%81%99%e3%82%8b%e4%ba%8b%e4%be%8b%e7%a0%94%e7%a9%b6\/\" target=\"_self\" aria-labelledby=\"uael-post-29224\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-29224>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\t\t<div class=\"uael-post__thumbnail\">\n\t\t\t\n\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%83%96%e3%83%ad%e3%82%b0\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e8%84%85%e5%a8%81%e3%83%a2%e3%83%87%e3%83%aa%e3%83%b3%e3%82%b0%ef%bc%9amdr-ivdr%e3%82%b5%e3%82%a4%e3%83%90%e3%83%bc%e3%82%bb\/\" target=\"_self\" title=\"\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u8105\u5a01\u30e2\u30c7\u30ea\u30f3\u30b0\uff1aMDR\/IVDR\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u306eSTRIDE\"><img loading=\"lazy\" decoding=\"async\" width=\"768\" height=\"511\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25-768x511.png\" class=\"attachment-medium_large size-medium_large wp-image-24102\" alt=\"CPV\u30d8\u30c3\u30c0\u30fc\u753b\u50cf\u30d6\u30ed\u30b04\u670825\u65e5\" srcset=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25-768x511.png 768w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25-300x200.png 300w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25-1024x681.png 1024w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25-1536x1022.png 1536w, https:\/\/www.rephine.com\/wp-content\/uploads\/2025\/04\/CPV-Header-image-blog-apr-25.png 2000w\" sizes=\"(max-width: 768px) 100vw, 768px\" \/><\/a>\n\t\t\t<span class=\"uael-post__terms\"><span class=\"uael-listing__terms-link\">\u30d6\u30ed\u30b0<\/span><\/span>\t\t<\/div>\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%83%96%e3%83%ad%e3%82%b0\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e8%84%85%e5%a8%81%e3%83%a2%e3%83%87%e3%83%aa%e3%83%b3%e3%82%b0%ef%bc%9amdr-ivdr%e3%82%b5%e3%82%a4%e3%83%90%e3%83%bc%e3%82%bb\/\" target=\"_self\">\n\t\t\t\t\u533b\u7642\u6a5f\u5668\u306b\u304a\u3051\u308b\u8105\u5a01\u30e2\u30c7\u30ea\u30f3\u30b0\uff1aMDR\/IVDR\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u306e\u305f\u3081\u306eSTRIDE\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tSTRIDE\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u8105\u5a01\u30e2\u30c7\u30ea\u30f3\u30b0\u624b\u6cd5\u304c\u3001\u533b ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%83%96%e3%83%ad%e3%82%b0\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ab%e3%81%8a%e3%81%91%e3%82%8b%e8%84%85%e5%a8%81%e3%83%a2%e3%83%87%e3%83%aa%e3%83%b3%e3%82%b0%ef%bc%9amdr-ivdr%e3%82%b5%e3%82%a4%e3%83%90%e3%83%bc%e3%82%bb\/\" target=\"_self\" aria-labelledby=\"uael-post-26712\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-26712>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\n<div class=\"uael-post-wrapper   \">\n\t<div class=\"uael-post__bg-wrap uael-bg-wrap-disabled \">\n\n\t\t\t\t\n\t\t<div class=\"uael-post__inner-wrap uael-inner-wrap-disabled\">\n\n\t\t\n\t\t\t\n\t\t\t<div class=\"uael-post__content-wrap uael-content-wrap-disabled\">\n\t\t\t\t\t<h3 class=\"uael-post__title\">\n\n\t\t\n\t\t\t\t\t\t<a href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e3%82%bb%e3%82%ad%e3%83%a5%e3%83%aa%e3%83%86%e3%82%a3%e3%83%aa%e3%82%b9%e3%82%af%e7%ae%a1%e7%90%86%ef%bc%9amdr%e3%81%8a%e3%82%88%e3%81%b3ivdr%e3%82%b3\/\" target=\"_self\">\n\t\t\t\t\u533b\u7642\u6a5f\u5668\u306e\u30bb\u30ad\u30e5\u30ea\u30c6\u30a3\u30ea\u30b9\u30af\u7ba1\u7406\uff1aMDR\u304a\u3088\u3073IVDR\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u30db\u30ef\u30a4\u30c8\u30da\u30fc\u30d1\u30fc\t\t\t<\/a>\n\n\t\t\t\t<\/h3>\n\t\t\n\t\t<div class=\"uael-post__excerpt\">\n\t\t\tRephine\u306e\u5c02\u9580\u5bb6\u30ac\u30a4\u30c9\u3067\u3001\u30b5\u30a4\u30d0\u30fc\u30bb\u30ad\u30e5\u30ea\u30c6 ...\t\t<\/div>\n\n\t\t\t\t\t<a class=\"uael-post__read-more elementor-button\" href=\"https:\/\/www.rephine.com\/ja\/resources\/%e3%82%ac%e3%82%a4%e3%83%89\/%e5%8c%bb%e7%99%82%e6%a9%9f%e5%99%a8%e3%81%ae%e3%82%bb%e3%82%ad%e3%83%a5%e3%83%aa%e3%83%86%e3%82%a3%e3%83%aa%e3%82%b9%e3%82%af%e7%ae%a1%e7%90%86%ef%bc%9amdr%e3%81%8a%e3%82%88%e3%81%b3ivdr%e3%82%b3\/\" target=\"_self\" aria-labelledby=\"uael-post-26736\">\n\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-icon elementor-align-icon-left\">\n\n\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t<span class=\"elementor-button-text\" id=uael-post-26736>\u7d9a\u304d\u3092\u8aad\u3080<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t<\/a>\n\t\t\t\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\n\t<\/div>\n\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\n\t\t<\/div>\n\n\t\t\t\t\t\t<\/div>\n\t\t<div class=\"uael-post__footer\">\n\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-75c39604 elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"75c39604\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-16bf29e5\" data-id=\"16bf29e5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-51a28b3f elementor-widget elementor-widget-template\" data-id=\"51a28b3f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-template\">\n\t\t\t\t\t<div data-elementor-type=\"section\" data-elementor-id=\"25484\" class=\"elementor elementor-25484 elementor-5998 elementor-5998\" data-elementor-post-type=\"elementor_library\">\n\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-498fad7a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"498fad7a\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-2293df6b\" data-id=\"2293df6b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-55b1c472 elementor-widget elementor-widget-heading\" data-id=\"55b1c472\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">\u3054\u9023\u7d61\u3092\u304a\u5f85\u3061\u3057\u3066\u304a\u308a\u307e\u3059<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b57f85 elementor-widget elementor-widget-text-editor\" data-id=\"4b57f85\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\u30bd\u30fc\u30b7\u30e3\u30eb\uff1a <a href=\"https:\/\/www.linkedin.com\/company\/rephine-limited\/\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" style=\"margin: -6px 0px 0px 10px;\" src=\"https:\/\/www.rephine.com\/wp-content\/uploads\/2022\/03\/linkedin.svg\" alt=\"\u30ea\u30f3\u30af\u30c8\u30a4\u30f3\"><\/a>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-bd88d99 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"bd88d99\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-3dce0d7\" data-id=\"3dce0d7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-864a2a1 elementor-widget elementor-widget-text-editor\" data-id=\"864a2a1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\"><span style=\"color: #ffffff;\"><strong>REPHINE \u672c\u793e<\/strong><\/span><\/p><ul><li><strong>\u30b9\u30c6\u30a3\u30fc\u30d6\u30cd\u30fc\u30b8\u3001\u30a4\u30ae\u30ea\u30b9<\/strong><\/li><li><span style=\"color: #1c1f3e;\"><strong><a style=\"color: #1c1f3e;\" href=\"tel:441763853135\">+44 1763 853135<\/a><\/strong><\/span><\/li><\/ul><p><span style=\"color: #ffffff;\"><strong>REPHINE BARCELONA S.L.U<\/strong><\/span><\/p><ul><li><strong>\u30d0\u30eb\u30bb\u30ed\u30ca\u3001\u30b9\u30da\u30a4\u30f3 <span style=\"color: #1c1f3e;\"> <\/span><\/strong><\/li><li><strong><span style=\"color: #1c1f3e;\"><a style=\"color: #1c1f3e;\" href=\"\u96fb\u8a71\u756a\u53f7\uff1a+34%20934%20178065\">+34 934 178065<\/a><\/span><\/strong><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-inner-column elementor-element elementor-element-0a260b8\" data-id=\"0a260b8\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-50288ff elementor-widget elementor-widget-text-editor\" data-id=\"50288ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p style=\"text-align: left;\"><span style=\"color: #ffffff;\"><strong>REPHINE CHINA<\/strong><\/span><\/p>\n<ul>\n<li><strong>\u4e0a\u6d77\u3001\u4e2d\u56fd<\/strong><strong style=\"color: var( --e-global-color-text ); background-color: var( --e-global-color-secondary ); font-family: var( --e-global-typography-primary-font-family ), Sans-serif;\">&nbsp;<\/strong><\/li>\n<\/ul><div><b><br><\/b><\/div>\n<p><span style=\"color: #ffffff;\"><strong>REPHINE INDIA<\/strong><\/span><\/p>\n<ul>\n<li><strong>\u30cf\u30a4\u30c7\u30e9\u30d0\u30fc\u30c9\u3001\u30a4\u30f3\u30c9&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp;<span style=\"color: #1c1f3e;\">&nbsp;<\/span><\/strong><\/li>\n<\/ul><div><font color=\"#1c1f3e\"><b><br><\/b><\/font><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-31242ff3\" data-id=\"31242ff3\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-9b92bb4 elementor-button-align-start elementor-widget elementor-widget-form\" data-id=\"9b92bb4\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;step_next_label&quot;:&quot;\\u6b21\\u3078&quot;,&quot;step_previous_label&quot;:&quot;\\u524d\\u3078&quot;,&quot;button_width&quot;:&quot;100&quot;,&quot;step_type&quot;:&quot;number_text&quot;,&quot;step_icon_shape&quot;:&quot;circle&quot;}\" data-widget_type=\"form.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<form class=\"elementor-form\" method=\"post\" name=\"\u30d5\u30a9\u30fc\u30e0\" aria-label=\"\u30d5\u30a9\u30fc\u30e0\">\n\t\t\t<input type=\"hidden\" name=\"post_id\" value=\"25484\"\/>\n\t\t\t<input type=\"hidden\" name=\"form_id\" value=\"9b92bb4\"\/>\n\t\t\t<input type=\"hidden\" name=\"referer_title\" value=\"Rephine\" \/>\n\n\t\t\t\n\t\t\t<div class=\"elementor-form-fields-wrapper elementor-labels-\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-fname elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-fname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u540d\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[fname]\" id=\"form-field-fname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u540d\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-lname elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-lname\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u59d3\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[lname]\" id=\"form-field-lname\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u59d3\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-phone elementor-col-50\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-phone\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u96fb\u8a71\u756a\u53f7\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[phone]\" id=\"form-field-phone\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u96fb\u8a71\u756a\u53f7\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-country elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-country\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\tCountry\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-caret-down\"><\/i>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[country]\" id=\"form-field-country\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">Enter Your Country<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"United Kingdom\">United Kingdom<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"United States\">United States<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\">---<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Afghanistan\">Afghanistan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Albania\">Albania<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Algeria\">Algeria<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"American Samoa\">American Samoa<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Andorra\">Andorra<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Angola\">Angola<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Anguilla\">Anguilla<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Antigua and Barbuda\">Antigua and Barbuda<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Argentina\">Argentina<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Armenia\">Armenia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Armenia\">Armenia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Aruba\">Aruba<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Australia\">Australia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Austria\">Austria<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Azerbaijan\">Azerbaijan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bahamas\">Bahamas<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bahrain\">Bahrain<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bangladesh\">Bangladesh<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Barbados\">Barbados<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Belarus\">Belarus<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Belgium\">Belgium<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Belize\">Belize<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Benin\">Benin<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bermuda\">Bermuda<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bhutan\">Bhutan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bolivia\">Bolivia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bonaire\">Bonaire<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bosnia and Herzegovina\">Bosnia and Herzegovina<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Botswana\">Botswana<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bouvet Island (Bouvetoya)\">Bouvet Island (Bouvetoya)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Brazil\">Brazil<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"British Indian Ocean Territory (Chagos Archipelago)\">British Indian Ocean Territory (Chagos Archipelago)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"British Virgin Islands\">British Virgin Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Brunei Darussalam\">Brunei Darussalam<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Bulgaria\">Bulgaria<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Burkina Faso\">Burkina Faso<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Burundi\">Burundi<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cambodia\">Cambodia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cameroon\">Cameroon<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Canada\">Canada<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cape Verde\">Cape Verde<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cayman Islands\">Cayman Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Central African Republic\">Central African Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Chad\">Chad<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Chile\">Chile<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"China\">China<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Christmas Island\">Christmas Island<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cocos (Keeling) Islands\">Cocos (Keeling) Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Colombia\">Colombia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Comoros\">Comoros<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Congo\">Congo<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Congo\">Congo<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cook Islands\">Cook Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Costa Rica\">Costa Rica<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cote d&#039;Ivoire\">Cote d&#039;Ivoire<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Croatia\">Croatia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cuba\">Cuba<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cura\u00e7ao\">Cura\u00e7ao<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cyprus\">Cyprus<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Cyprus\">Cyprus<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Czech Republic\">Czech Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Denmark\">Denmark<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Djibouti\">Djibouti<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Dominica\">Dominica<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Dominican Republic\">Dominican Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ecuador\">Ecuador<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Egypt\">Egypt<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"El Salvador\">El Salvador<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Equatorial Guinea\">Equatorial Guinea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Eritrea\">Eritrea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Estonia\">Estonia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ethiopia\">Ethiopia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Falkland Islands (Malvinas)\">Falkland Islands (Malvinas)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Faroe Islands\">Faroe Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Fiji\">Fiji<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Finland\">Finland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"France\">France<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"French Guiana\">French Guiana<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"French Polynesia\">French Polynesia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"French Southern Territories\">French Southern Territories<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Gabon\">Gabon<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Gambia\">Gambia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Georgia\">Georgia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Germany\">Germany<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ghana\">Ghana<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Gibraltar\">Gibraltar<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Greece\">Greece<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Greenland\">Greenland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Grenada\">Grenada<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guadeloupe\">Guadeloupe<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guam\">Guam<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guatemala\">Guatemala<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guernsey\">Guernsey<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guinea\">Guinea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guinea-Bissau\">Guinea-Bissau<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Guyana\">Guyana<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Haiti\">Haiti<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Heard Island and McDonald Islands\">Heard Island and McDonald Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Holy See (Vatican City State)\">Holy See (Vatican City State)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Honduras\">Honduras<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Hong Kong\">Hong Kong<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Hungary\">Hungary<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Iceland\">Iceland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"India\">India<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Indonesia\">Indonesia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Iran\">Iran<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Iraq\">Iraq<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ireland\">Ireland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Isle of Man\">Isle of Man<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Israel\">Israel<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Italy\">Italy<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Jamaica\">Jamaica<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Japan\">Japan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Jersey\">Jersey<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Jordan\">Jordan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kazakhstan\">Kazakhstan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kazakhstan\">Kazakhstan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kenya\">Kenya<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kiribati\">Kiribati<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Korea\">Korea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Korea\">Korea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kuwait\">Kuwait<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Kyrgyz Republic\">Kyrgyz Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Lao People&#039;s Democratic Republic\">Lao People&#039;s Democratic Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Latvia\">Latvia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Lebanon\">Lebanon<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Lesotho\">Lesotho<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Liberia\">Liberia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Libyan Arab Jamahiriya\">Libyan Arab Jamahiriya<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Liechtenstein\">Liechtenstein<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Lithuania\">Lithuania<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Luxembourg\">Luxembourg<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Macao\">Macao<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Macedonia\">Macedonia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Madagascar\">Madagascar<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Malawi\">Malawi<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Malaysia\">Malaysia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Maldives\">Maldives<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mali\">Mali<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Malta\">Malta<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Marshall Islands\">Marshall Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Martinique\">Martinique<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mauritania\">Mauritania<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mauritius\">Mauritius<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mayotte\">Mayotte<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Micronesia\">Micronesia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Moldova\">Moldova<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Monaco\">Monaco<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mongolia\">Mongolia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Montenegro\">Montenegro<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Montserrat\">Montserrat<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Morocco\">Morocco<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mozambique\">Mozambique<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Myanmar\">Myanmar<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Namibia\">Namibia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Nauru\">Nauru<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Nepal\">Nepal<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Netherlands\">Netherlands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Netherlands Antilles\">Netherlands Antilles<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"New Caledonia\">New Caledonia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"New Zealand\">New Zealand<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Nicaragua\">Nicaragua<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Niger\">Niger<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Nigeria\">Nigeria<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Niue\">Niue<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Norfolk Island\">Norfolk Island<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Northern Mariana Islands\">Northern Mariana Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Mexico\">Mexico<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Norway\">Norway<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Oman\">Oman<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Pakistan\">Pakistan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Palau\">Palau<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Palestinian Territory\">Palestinian Territory<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Panama\">Panama<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Papua New Guinea\">Papua New Guinea<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Paraguay\">Paraguay<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Peru\">Peru<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Philippines\">Philippines<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Pitcairn Islands\">Pitcairn Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Poland\">Poland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Portugal\">Portugal<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Puerto Rico\">Puerto Rico<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Qatar\">Qatar<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Reunion\">Reunion<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Romania\">Romania<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Russian Federation\">Russian Federation<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Rwanda\">Rwanda<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Barthelemy\">Saint Barthelemy<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Helena\">Saint Helena<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Kitts and Nevis\">Saint Kitts and Nevis<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Lucia\">Saint Lucia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Martin\">Saint Martin<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Pierre and Miquelon\">Saint Pierre and Miquelon<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saint Vincent and the Grenadines\">Saint Vincent and the Grenadines<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Samoa\">Samoa<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"San Marino\">San Marino<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sao Tome and Principe\">Sao Tome and Principe<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Saudi Arabia\">Saudi Arabia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Senegal\">Senegal<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Serbia\">Serbia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Seychelles\">Seychelles<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sierra Leone\">Sierra Leone<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Singapore\">Singapore<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sint Maarten (Netherlands)\">Sint Maarten (Netherlands)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Slovakia (Slovak Republic)\">Slovakia (Slovak Republic)<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Slovenia\">Slovenia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Solomon Islands\">Solomon Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Somalia\">Somalia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"South Africa\">South Africa<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"South Georgia &amp; S. Sandwich Islands\">South Georgia &amp; S. Sandwich Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Spain\">Spain<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sri Lanka\">Sri Lanka<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sudan\">Sudan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Suriname\">Suriname<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Svalbard &amp; Jan Mayen Islands\">Svalbard &amp; Jan Mayen Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Swaziland\">Swaziland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Sweden\">Sweden<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Switzerland\">Switzerland<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Syrian Arab Republic\">Syrian Arab Republic<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Taiwan\">Taiwan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tajikistan\">Tajikistan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tanzania\">Tanzania<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Thailand\">Thailand<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Timor-Leste\">Timor-Leste<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Togo\">Togo<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tokelau\">Tokelau<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tonga\">Tonga<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Trinidad and Tobago\">Trinidad and Tobago<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tunisia\">Tunisia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Turkey\">Turkey<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Turkey\">Turkey<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Turkmenistan\">Turkmenistan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Turks and Caicos Islands\">Turks and Caicos Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Tuvalu\">Tuvalu<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"U.S. Virgin Islands\">U.S. Virgin Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"U.S. Minor Outlying Islands\">U.S. Minor Outlying Islands<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Uganda\">Uganda<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Ukraine\">Ukraine<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"United Arab Emirates\">United Arab Emirates<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Uruguay\">Uruguay<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Uzbekistan\">Uzbekistan<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Vanuatu\">Vanuatu<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Venezuela\">Venezuela<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Vietnam\">Vietnam<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Wallis and Futuna\">Wallis and Futuna<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Western Sahara\">Western Sahara<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Yemen\">Yemen<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Zambia\">Zambia<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"Zimbabwe\">Zimbabwe<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-company elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-company\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u4f1a\u793e\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[company]\" id=\"form-field-company\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u4f1a\u793e\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-text elementor-field-group elementor-column elementor-field-group-job elementor-col-50 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-job\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u5f79\u8077\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"text\" name=\"form_fields[job]\" id=\"form-field-job\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u5f79\u8077\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-email elementor-field-group elementor-column elementor-field-group-email elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-email\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<input size=\"1\" type=\"email\" name=\"form_fields[email]\" id=\"form-field-email\" class=\"elementor-field elementor-size-sm  elementor-field-textual\" placeholder=\"\u30e1\u30fc\u30eb\u30a2\u30c9\u30ec\u30b9\" required=\"required\">\n\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-select elementor-field-group elementor-column elementor-field-group-InterestedIn elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-InterestedIn\" class=\"elementor-field-label elementor-screen-only\">\n\t\t\t\t\t\t\t\t\u95a2\u5fc3\u306e\u3042\u308b\u5206\u91ce\t\t\t\t\t\t\t<\/label>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field elementor-select-wrapper remove-before \">\n\t\t\t<div class=\"select-caret-down-wrapper\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"eicon-caret-down\"><\/i>\t\t\t<\/div>\n\t\t\t<select name=\"form_fields[InterestedIn]\" id=\"form-field-InterestedIn\" class=\"elementor-field-textual elementor-size-sm\" required=\"required\">\n\t\t\t\t\t\t\t\t\t<option value=\"\">\u304a\u554f\u3044\u5408\u308f\u305b\u5185\u5bb9\u3092\u9078\u629e\u3057\u3066\u304f\u3060\u3055\u3044<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u76e3\u67fb\">\u76e3\u67fb<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u76e3\u67fb\u5bfe\u8c61\u8005\">\u76e3\u67fb\u5bfe\u8c61\u8005<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u63a1\u7528\u60c5\u5831\">\u63a1\u7528\u60c5\u5831<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0\">\u30b3\u30f3\u30b5\u30eb\u30c6\u30a3\u30f3\u30b0<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u30b4\u30fc\u30eb\u30c9\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3\">\u30b4\u30fc\u30eb\u30c9\u30bd\u30ea\u30e5\u30fc\u30b7\u30e7\u30f3<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0\">\u30de\u30fc\u30b1\u30c6\u30a3\u30f3\u30b0<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u533b\u7642\u6a5f\u5668\">\u533b\u7642\u6a5f\u5668<\/option>\n\t\t\t\t\t\t\t\t\t<option value=\"\u305d\u306e\u4ed6\">\u305d\u306e\u4ed6<\/option>\n\t\t\t\t\t\t\t<\/select>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<div class=\"elementor-field-type-textarea elementor-field-group elementor-column elementor-field-group-message elementor-col-100 elementor-field-required\">\n\t\t\t\t\t\t\t\t\t\t\t\t<label for=\"form-field-message\" class=\"elementor-field-label 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