{"id":7994,"date":"2025-02-26T15:49:15","date_gmt":"2025-02-26T07:49:15","guid":{"rendered":"https:\/\/regask.com\/?p=7994"},"modified":"2025-02-28T18:07:26","modified_gmt":"2025-02-28T10:07:26","slug":"%e3%83%95%e3%83%a9%e3%83%b3%e3%82%b9ansm-ce%e3%83%9e%e3%83%bc%e3%82%af%e5%85%8d%e9%99%a4","status":"publish","type":"post","link":"https:\/\/regask.com\/ja\/france-ansm-ce-mark-exemption\/","title":{"rendered":"ANSM (\u30d5\u30e9\u30f3\u30b9) \u304c\u88fd\u54c1\u306b\u5bfe\u3059\u308b CE \u30de\u30fc\u30af\u514d\u9664\u30d7\u30ed\u30bb\u30b9\u3092\u660e\u78ba\u306b\u2026"},"content":{"rendered":"<p>\u306e\u4e0a <strong>2025\u5e741\u670827\u65e5<\/strong>\u3001 <strong>\u56fd\u5bb6\u533b\u85ac\u54c1\u30fb\u5065\u5eb7\u88fd\u54c1\u5b89\u5168\u4fdd\u969c\u5c40 (ANSM)<\/strong> \u30d5\u30e9\u30f3\u30b9\u3067\u306f\u3001\u53d6\u5f97\u30d7\u30ed\u30bb\u30b9\u306b\u95a2\u3059\u308b\u91cd\u8981\u306a\u6700\u65b0\u60c5\u5831\u304c\u767a\u8868\u3055\u308c\u307e\u3057\u305f\u3002 <strong>CE\u30de\u30fc\u30af\u514d\u9664<\/strong> \u533b\u7642\u6a5f\u5668\u306b\u3064\u3044\u3066\u3002\u3053\u306e\u898f\u5236\u306e\u660e\u78ba\u5316\u3067\u306f\u3001\u88fd\u9020\u696d\u8005\u304c\u30d5\u30e9\u30f3\u30b9\u3067\u533b\u7642\u6a5f\u5668\u3092\u8ca9\u58f2\u3059\u308b\u305f\u3081\u306e\u627f\u8a8d\u3092\u6c42\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u5177\u4f53\u7684\u306a\u6761\u4ef6\u3092\u6982\u8aac\u3057\u3066\u3044\u307e\u3059\u3002 <strong>CE\u8a8d\u8a3c\u306a\u3057<\/strong>\u3001\u901a\u5e38\u306f\u9075\u5b88\u3092\u78ba\u8a8d\u3059\u308b\u305f\u3081\u306b\u5fc5\u8981\u3068\u306a\u308b <strong>EU\u306e\u5b89\u5168\u6027\u3068\u6027\u80fd\u57fa\u6e96<\/strong>.<\/p>\n<p>ANSM\u306f\u3001\u3053\u308c\u3089\u306e\u514d\u9664\u304c\u8a8d\u3081\u3089\u308c\u3066\u3044\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u3066\u3044\u308b\u3002 <strong>\u4f8b\u5916\u7684\u306a\u72b6\u6cc1\u4e0b\u3067\u306e\u307f<\/strong>\u4e3b\u306b\u4fdd\u8b77\u3059\u308b\u305f\u3081\u306b <strong>\u516c\u8846\u885b\u751f\u3068\u60a3\u8005\u306e\u5b89\u5168<\/strong>\u3001 \u306b\u5f93\u3063\u3066 <strong>EU\u898f\u52472017\/745\u7b2c59\u6761<\/strong>.<\/p>\n<p>CE\u30de\u30fc\u30af\u306e\u514d\u9664\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u5fc5\u8981\u6027\u3084\u60a3\u8005\u306e\u5b89\u5168\u4e0a\u306e\u61f8\u5ff5\u304c\u3042\u308b\u5834\u5408\u306b\u53b3\u5bc6\u306b\u9650\u5b9a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u8cc7\u683c\u3092\u5f97\u308b\u306b\u306f\u3001\u88fd\u9020\u696d\u8005\u306f\u4ee5\u4e0b\u3092\u5b9f\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <strong>\u60a3\u8005\u306b\u3068\u3063\u3066\u5927\u304d\u306a\u5229\u76ca<\/strong>\u5b89\u5168\u6027\u3068\u6027\u80fd\u30c7\u30fc\u30bf\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u3001 <strong>\u4ee3\u66ff\u88fd\u54c1\u306a\u3057<\/strong> \u5e02\u5834\u3067\u5165\u624b\u53ef\u80fd\u3067\u3059\u3002<\/p>\n<p>\u3053\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3067\u306f 2 \u7a2e\u985e\u306e\u514d\u9664\u304c\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002 <strong>\u500b\u4eba\u514d\u9664<\/strong> \u7dca\u6025\u306e\u533b\u7642\u30cb\u30fc\u30ba\u306b\u57fa\u3065\u3044\u3066\u7279\u5b9a\u306e\u60a3\u8005\u306b\u9069\u7528\u3055\u308c\u3001 <strong>\u30b0\u30ed\u30fc\u30d0\u30eb\u514d\u9664<\/strong> \u3088\u308a\u5e83\u7bc4\u306a\u30b1\u30fc\u30b9\u3092\u30ab\u30d0\u30fc\u3059\u308b\u304c\u3001 <strong>\u6642\u9593\u5236\u9650\u3068\u7bc4\u56f2\u5236\u9650\u304c\u3042\u308b<\/strong>\u514d\u9664\u4e0b\u3067\u6a5f\u5668\u3092\u4f7f\u7528\u3059\u308b\u533b\u7642\u5f93\u4e8b\u8005\u306f\u3001CE \u30de\u30fc\u30af\u304c\u4ed8\u3044\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u60a3\u8005\u306b\u4f1d\u3048\u3001\u660e\u78ba\u306a\u540c\u610f\u3092\u5f97\u3066\u3001\u6a5f\u5668\u306e\u4f7f\u7528\u306b\u95a2\u9023\u3059\u308b\u3042\u3089\u3086\u308b\u4e8b\u6545\u3084\u30ea\u30b9\u30af\u3092\u5831\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>ANSM\u306f\u7533\u8acb\u3092\u8a55\u4fa1\u3059\u308b <strong>\u30b1\u30fc\u30b9\u30d0\u30a4\u30b1\u30fc\u30b9\u3067<\/strong>\u514d\u9664\u304c\u7d99\u7d9a\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b <strong>\u4f8b\u5916\u7684\u306a<\/strong> \u8fc2\u56de\u3057\u306a\u3044\u3067\u304f\u3060\u3055\u3044 <strong>\u6a19\u6e96\u7684\u306a\u898f\u5236\u7d4c\u8def<\/strong>\u81e8\u5e8a\u8abf\u67fb\u3092\u542b\u3080\u3002<\/p>\n<p>\u30d5\u30e9\u30f3\u30b9\u3067\u533b\u7642\u6a5f\u5668\u306e\u4f9b\u7d66\u3084\u4f7f\u7528\u306b\u643a\u308f\u308b\u88fd\u9020\u696d\u8005\u3084\u533b\u7642\u63d0\u4f9b\u8005\u306f\u3001ANSM\u306e\u6700\u65b0\u306e\u30ac\u30a4\u30c9\u30e9\u30a4\u30f3\u3092\u6ce8\u610f\u6df1\u304f\u78ba\u8a8d\u3057\u3001 <strong>\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9<\/strong> \u305d\u3057\u3066 <strong>\u9069\u5207\u306a\u6587\u66f8<\/strong> \u514d\u9664\u3092\u6c42\u3081\u308b\u5834\u5408\u3002<\/p>\n<p>\u8a73\u7d30\u306b\u3064\u3044\u3066\u306f\u3001ANSM\u306e\u516c\u5f0f\u51fa\u7248\u7269\u3092\u53c2\u7167\u3057\u3066\u304f\u3060\u3055\u3044\u3002 <strong>CE\u30de\u30fc\u30af\u514d\u9664<\/strong>.<\/p>","protected":false},"excerpt":{"rendered":"<p>2025\u5e741\u670827\u65e5\u3001\u30d5\u30e9\u30f3\u30b9\u533b\u85ac\u54c1\u30fb\u533b\u7642\u88fd\u54c1\u5b89\u5168\u5e81\uff08ANSM\uff09\u306f\u3001\u533b\u7642\u6a5f\u5668\u306eCE\u30de\u30fc\u30af\u514d\u9664\u53d6\u5f97\u624b\u7d9a\u304d\u306b\u95a2\u3059\u308b\u91cd\u8981\u306a\u6700\u65b0\u60c5\u5831\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3053\u306e\u898f\u5236\u306e\u660e\u78ba\u5316\u3067\u306f\u3001EU\u306e\u5b89\u5168\u6027\u304a\u3088\u3073\u6027\u80fd\u57fa\u6e96\u3078\u306e\u9069\u5408\u3092\u8a3c\u660e\u3059\u308b\u305f\u3081\u306b\u901a\u5e38\u5fc5\u8981\u3068\u3055\u308c\u308bCE\u8a8d\u8a3c\u3092\u53d6\u5f97\u305b\u305a\u306b\u3001\u88fd\u9020\u696d\u8005\u304c\u30d5\u30e9\u30f3\u30b9\u3067\u533b\u7642\u6a5f\u5668\u306e\u8ca9\u58f2\u627f\u8a8d\u3092\u7533\u8acb\u3067\u304d\u308b\u5177\u4f53\u7684\u306a\u6761\u4ef6\u304c\u6982\u8aac\u3055\u308c\u3066\u3044\u307e\u3059\u3002ANSM\u306f\u3001\u3053\u308c\u3089\u306e\u514d\u9664\u306f\u3001EU\u898f\u52472017\/745\u7b2c59\u6761\u306b\u57fa\u3065\u304d\u3001\u4e3b\u306b\u516c\u8846\u885b\u751f\u3068\u60a3\u8005\u306e\u5b89\u5168\u3092\u5b88\u308b\u305f\u3081\u306e\u4f8b\u5916\u7684\u306a\u72b6\u6cc1\u306b\u304a\u3044\u3066\u306e\u307f\u8a8d\u3081\u3089\u308c\u308b\u3053\u3068\u3092\u5f37\u8abf\u3057\u3066\u3044\u307e\u3059\u3002CE\u30de\u30fc\u30af\u306e\u514d\u9664\u306f\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u5fc5\u8981\u6027\u304c\u5207\u5b9f\u306b\u5b58\u5728\u3059\u308b\u5834\u5408\u306b\u306e\u307f\u53b3\u5bc6\u306b\u5236\u9650\u3055\u308c\u307e\u3059\u3002<\/p>","protected":false},"author":43,"featured_media":8074,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[509,39],"tags":[165,602],"class_list":["post-7994","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-france-regulations","category-medical-devices-insights","tag-public-health","tag-import-and-export-regs"],"acf":[],"yoast_head":"<!-- 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Read more at RegASK.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/regask.com\/ja\/\u30d5\u30e9\u30f3\u30b9ansm-ce\u30de\u30fc\u30af\u514d\u9664\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ANSM (France) Clarifies CE Mark Exemption Process for Medical Devices\" \/>\n<meta property=\"og:description\" content=\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance &amp; patient safety. Read more at RegASK.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/regask.com\/ja\/\u30d5\u30e9\u30f3\u30b9ansm-ce\u30de\u30fc\u30af\u514d\u9664\/\" \/>\n<meta property=\"og:site_name\" content=\"RegASK\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/RegASKRegulatoryAffairs\/\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-26T07:49:15+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-28T10:07:26+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/regask.com\/wp-content\/uploads\/2025\/02\/ansm-france-clarifies-ce-mark-exemption-process-medical-devices.png\" \/>\n\t<meta property=\"og:image:width\" content=\"800\" \/>\n\t<meta property=\"og:image:height\" content=\"600\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Reva Ananda\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:site\" content=\"@ASKRegASK\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Reva Ananda\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"2\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/\"},\"author\":{\"name\":\"Reva Ananda\",\"@id\":\"https:\\\/\\\/regask.com\\\/#\\\/schema\\\/person\\\/4023a3aab44f61a84d06ca8abfcbe926\"},\"headline\":\"ANSM (France) Clarifies CE Mark Exemption Process for M&hellip;\",\"datePublished\":\"2025-02-26T07:49:15+00:00\",\"dateModified\":\"2025-02-28T10:07:26+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/\"},\"wordCount\":276,\"publisher\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/ansm-france-clarifies-ce-mark-exemption-process-medical-devices.png\",\"keywords\":[\"Public Health\",\"Import and Export Regs\"],\"articleSection\":[\"France\",\"Medical Devices\"],\"inLanguage\":\"ja\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/\",\"url\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/\",\"name\":\"France ANSM Updates CE Mark Exemption Process | RegASK\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/regask.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/regask.com\\\/france-ansm-ce-mark-exemption\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/regask.com\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/ansm-france-clarifies-ce-mark-exemption-process-medical-devices.png\",\"datePublished\":\"2025-02-26T07:49:15+00:00\",\"dateModified\":\"2025-02-28T10:07:26+00:00\",\"description\":\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance & patient safety. 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