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class=\"wp-block-heading\">\u7f8e\u5bb9\u5668\u5177\uff1aEU\u306b\u304a\u3051\u308b\u533b\u7642\u6a5f\u5668\u304b\u3069\u3046\u304b\u3092\u77e5\u308b\u306b\u306f\uff1f<\/h2>\n\n<p>\u7f8e\u5bb9\u30c4\u30fc\u30eb\u3092\u5206\u985e\u3059\u308b\u306e\u306f\u4e00\u898b\u7c21\u5358\u306a\u3053\u3068\u306e\u3088\u3046\u306b\u601d\u3048\u308b\u304c\u3001\u591a\u304f\u306e\u30d6\u30e9\u30f3\u30c9\u304c\u3053\u306e\u91cd\u8981\u306a\u554f\u984c\u306b\u982d\u3092\u60a9\u307e\u305b\u3066\u3044\u308b\u3002<\/p>\n\n<p>EU\u306e\u57fa\u6e96\u3067\u306f  <strong>\u533b\u7642\u6a5f\u5668\u306f\u3001\u305d\u306e\u6a5f\u5668\u306e\u4f5c\u7528\u306b\u3088\u3063\u3066\u6cbb\u7652\u3001\u6cbb\u7642\u3001\u8a3a\u65ad\u3055\u308c\u308b\u533b\u5b66\u7684\u306a\u554f\u984c\u3084\u75c5\u6c17\u306b\u5bfe\u5fdc\u3059\u308b\u3082\u306e\u3067\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u3002 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is-resized\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/image2-1.png\" alt=\"\" class=\"wp-image-20813\" width=\"575\" height=\"205\"\/><\/figure>\n<\/div>\n<p>\u7f8e\u5bb9\u5668\u5177\u3084\u5316\u7ca7\u54c1\u306f\u30af\u30e9\u30b9I\u304b\u3089\u30af\u30e9\u30b9III\u306b\u5206\u985e\u3055\u308c\u3001\u6700\u3082\u898f\u5236\u304c\u53b3\u3057\u304f\u6642\u9593\u306e\u304b\u304b\u308b\u3082\u306e\u3067\u3059\u3002 BIORIUS\u306f\u3001\u88fd\u54c1\u5206\u985e\u306e\u5b9a\u7fa9\u4ed8\u3051\u3092\u30b5\u30dd\u30fc\u30c8<a href=\"New%20EU%20Regulations%20Concerning%20Medical%20Devices%20%E2%80%A2%20Biorius\">\u3057\u307e\u3059<\/a>\u3002  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class=\"wp-block-heading\">\u533b\u7642\u76ee\u7684\u306e\u306a\u3044\u533b\u7642\u6a5f\u5668<\/h3>\n\n<p>\u524d\u8ff0\u306e\u5b9a\u7fa9\u306b\u52a0\u3048\u3001\u533b\u7642\u6a5f\u5668\u306b\u306f\u610f\u56f3\u3055\u308c\u305f\u533b\u7642\u76ee\u7684\u304c\u306a\u3044\u5834\u5408\u3082\u3042\u308b\u3002<strong>\u3053\u306e\u5883\u754c\u7dda\u4e0a\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u306f\u3001\u5f53\u521d\u306f\u7f8e\u7684\u4f5c\u7528\u3092\u793a\u3059\u5316\u7ca7\u54c1\u3084\u7f8e\u5bb9\u5668\u5177\u3001\u307e\u305f\u306f\u7f8e\u7684\u4f5c\u7528\u3068\u3057\u3066\u300c\u96a0\u3055\u308c\u305f\u300d\u533b\u7642\u76ee\u7684\u304c\u542b\u307e<\/strong>\u308c\u308b\u3002 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href=\"https:\/\/biorius.com\/md\/did-my-cosmetic-product-become-a-medical-device\/\">\u8a18\u4e8b\u3092<\/a>\u66f8\u3044\u305f\u304c\u3001\u5ff5\u306e\u305f\u3081\u3001\u3053\u306e\u5225\u9928\u304c\u30bf\u30fc\u30b2\u30c3\u30c8\u306b\u3057\u3066\u3044\u308b6\u3064\u306e\u88fd\u54c1\u3092\u7d39\u4ecb\u3057\u3088\u3046\uff1a<\/p>\n\n<ul class=\"wp-block-list\">\n<li>\u30b3\u30f3\u30bf\u30af\u30c8\u30ec\u30f3\u30ba\u306a\u3069\u3001\u773c\u7403\u306b\u5165\u308c\u308b\u3082\u306e\u3001\u307e\u305f\u306f\u773c\u7403\u306b\u4ed8\u7740\u3055\u305b\u308b\u3082\u306e\u3002<\/li>\n\n\n\n<li>\u30bf\u30c8\u30a5\u30fc\u88fd\u54c1\u304a\u3088\u3073\u30d4\u30a2\u30b9\u3092\u9664\u304d\u3001\u89e3\u5256\u5b66\u7684\u69cb\u9020\u306e\u6539\u5909\u307e\u305f\u306f\u8eab\u4f53\u90e8\u4f4d\u306e\u56fa\u5b9a\u3092\u76ee\u7684\u3068\u3057\u3066\u3001\u5916\u79d1\u7684\u4fb5\u8972\u7684\u624b\u6bb5\u306b\u3088\u308a\u4eba\u4f53\u306b\u5168\u4f53\u7684\u307e\u305f\u306f\u90e8\u5206\u7684\u306b\u5c0e\u5165\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u88fd\u54c1\u2192\u30a4\u30f3\u30d7\u30e9\u30f3\u30c8&#8230;<\/li>\n\n\n\n<li>\u76ae\u4e0b\u6ce8\u5c04\u3001\u7c98\u819c\u4e0b\u6ce8\u5c04\u3001\u76ae\u5185\u6ce8\u5c04\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u5c0e\u5165\u306b\u3088\u308a\u3001\u9854\u9762\u307e\u305f\u306f\u305d\u306e\u4ed6\u306e\u771f\u76ae\u307e\u305f\u306f\u7c98\u819c\u306e\u5145\u586b\u306b\u4f7f\u7528\u3055\u308c\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u7269\u8cea\u3001\u7269\u8cea\u306e\u7d44\u307f\u5408\u308f\u305b\u307e\u305f\u306f\u7269\u54c1\uff08\u5165\u308c\u58a8\u306e\u3082\u306e\u3092\u9664\u304f\uff09\u2192\u76ae\u819a\u5145\u586b\u5264\u3001\u30de\u30a4\u30af\u30ed\u30cb\u30fc\u30c9\u30eb\u304a\u3088\u3073\u30e1\u30bd\u30bb\u30e9\u30d4\u30fc\u7528\u5177\u3002<\/li>\n\n\n\n<li>\u8102\u80aa\u5438\u5f15\u3001\u8102\u80aa\u5206\u89e3\u3001\u8102\u80aa\u5f62\u6210\u8853\u7528\u306e\u6a5f\u5668\u306a\u3069\u3001\u8102\u80aa\u7d44\u7e54\u3092\u6e1b\u5c11\u3001\u9664\u53bb\u3001\u307e\u305f\u306f\u7834\u58ca\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u610f\u56f3\u3057\u305f\u6a5f\u5668\u3002<\/li>\n\n\n\n<li>\u30b3\u30d2\u30fc\u30ec\u30f3\u30c8\u304a\u3088\u3073\u975e\u30b3\u30d2\u30fc\u30ec\u30f3\u30c8\u5149\u6e90\u3001\u5358\u8272\u304a\u3088\u3073\u5e83\u30b9\u30da\u30af\u30c8\u30eb\u5149\u6e90\u3092\u542b\u3080\u3001\u4eba\u4f53\u3078\u306e\u4f7f\u7528\u3092\u610f\u56f3\u3057\u305f\u9ad8\u5f37\u5ea6\u96fb\u78c1\u653e\u5c04\u653e\u51fa\u6a5f\u5668\uff08\u30ec\u30fc\u30b6\u30fc\u3084\u9ad8\u5f37\u5ea6\u30d1\u30eb\u30b9\u5149\u6a5f\u5668\u306a\u3069\uff09\u3002<\/li>\n\n\n\n<li>\u982d\u84cb\u3092\u8cab\u901a\u3059\u308b\u96fb\u6d41\u3084\u78c1\u5834\u3001\u96fb\u78c1\u5834\u3092\u5370\u52a0\u3057\u3066\u8133\u306e\u795e\u7d4c\u6d3b\u52d5\u3092\u5909\u5316\u3055\u305b\u308b\u8133\u523a\u6fc0\u7528\u6a5f\u5668\u2192\u3046\u3064\u75c5\u306e\u6cbb\u7642&#8230;  <\/li>\n<\/ul>\n\n<div class=\"wp-block-media-text alignwide is-stacked-on-mobile\" style=\"grid-template-columns:29% auto\"><figure class=\"wp-block-media-text__media\"><img decoding=\"async\" src=\"https:\/\/biorius.com\/wp-content\/uploads\/2023\/10\/european-flag-2.jpg\" alt=\"\" class=\"wp-image-17669 size-full\"\/><\/figure><div class=\"wp-block-media-text__content\">\n<p><strong>\u6ce8\u610f<\/strong>\uff1a\u30ea\u30b9\u30af\u3092\u8a98\u767a\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u88fd\u54c1\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u304c\u9644\u5c5e\u66f8XVI\u306b\u8ffd\u52a0\u3055\u308c\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002 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href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:02017R0745-20200424\">\u898f\u5247\uff08EU\uff092017\/745\u306b<\/a>\u6e96\u62e0\u3057\u3088\u3046\u3068\u3057\u3066\u304a\u308a\u3001\u3055\u3089\u306b\u4f55\u5343\u3082\u306e\u4f01\u696d\u304c\u304e\u308a\u304e\u308a\u307e\u3067\u305d\u306e\u6e96\u62e0\u3092\u5f85\u3068\u3046\u3068\u3057\u3066\u3044\u308b\u3002 \u3059\u3067\u306b\u5e73\u574718\u30f6\u6708\u3068\u3044\u3046\u9577\u3044\u30d7\u30ed\u30bb\u30b9\u671f\u9593\u304c\u4e88\u60f3\u3055\u308c\u308b\u3002<\/li>\n\n\n\n<li>\u5316\u7ca7\u54c1\u3084\u7f8e\u5bb9\u5668\u5177\u306e\u88fd\u9020\u696d\u8005\u3082\u3001\u9644\u5c5e\u66f8XVI\u304c\u65bd\u884c\u3055\u308c\u308c\u3070\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u304c\u3001\u73fe\u5728\u3067\u306f\u307e\u3060\u4e0d\u78ba\u5b9a\u8981\u7d20\u304c\u3042\u308b\u3002  <strong>\u3057\u305f\u304c\u3063\u3066\u3001\u4ed6\u306e\u4f55\u5343\u3082\u306e\u4f01\u696d\u306e\u3088\u3046\u306b\u6700\u5f8c\u306e\u77ac\u9593\u307e\u3067\u5f85\u3064\u3068\u3001\u9577\u3044\u30d7\u30ed\u30bb\u30b9\u6642\u9593\u304c\u304b\u304b\u308a\u3001\u5f53\u521d\u306e\u671f\u9650\u901a\u308a\u306b\u88fd\u54c1\u3092\u5e02\u5834\u306b\u51fa\u3059\u3053\u3068\u304c\u3067\u304d\u306a\u304f\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002<\/strong><\/li>\n<\/ol>\n\n<p>\u3053\u308c\u30892\u3064\u306e\u8981\u56e0\u304c\u91cd\u306a\u308a\u3001\u30ce\u30fc\u30c6\u30a3\u30d5\u30a1\u30a4\u30c9\u30fb\u30dc\u30c7\u30a3\uff08\u5fc5\u8981\u306a\u5834\u5408\uff09\u306e\u627f\u8a8d\u3092\u5f97\u308b\u306b\u306f\u6570\u5e74\u304b\u304b\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u3002 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