{"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":"%e6%b3%95%e5%9b%bd-ansm-ce-%e6%a0%87%e5%bf%97%e8%b1%81%e5%85%8d","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/france-ansm-ce-mark-exemption\/","title":{"rendered":"ANSM\uff08\u6cd5\u56fd\uff09\u6f84\u6e05\u4e86 M\u2026\u7684 CE \u6807\u5fd7\u8c41\u514d\u6d41\u7a0b"},"content":{"rendered":"<p>\u5728 <strong>2025 \u5e74 1 \u6708 27 \u65e5<\/strong>\uff0c \u8fd9 <strong>\u56fd\u5bb6\u836f\u54c1\u548c\u4fdd\u5065\u4ea7\u54c1\u5b89\u5168\u5c40\uff08ANSM\uff09<\/strong> \u6cd5\u56fd\u53d1\u5e03\u4e86\u5173\u4e8e\u83b7\u53d6 <strong>CE \u6807\u5fd7\u8c41\u514d<\/strong> \u533b\u7597\u5668\u68b0\u3002\u672c\u76d1\u7ba1\u6f84\u6e05\u6982\u8ff0\u4e86\u5236\u9020\u5546\u5728\u6cd5\u56fd\u5bfb\u6c42\u533b\u7597\u5668\u68b0\u9500\u552e\u6279\u51c6\u7684\u5177\u4f53\u6761\u4ef6 <strong>\u65e0CE\u8ba4\u8bc1<\/strong>\uff0c\u8fd9\u901a\u5e38\u9700\u8981\u786e\u8ba4\u662f\u5426\u7b26\u5408 <strong>\u6b27\u76df\u5b89\u5168\u548c\u6027\u80fd\u6807\u51c6<\/strong>.<\/p>\n<p>ANSM \u5f3a\u8c03\uff0c\u8fd9\u4e9b\u8c41\u514d\u662f <strong>\u4ec5\u5728\u7279\u6b8a\u60c5\u51b5\u4e0b<\/strong>\uff0c\u4e3b\u8981\u662f\u4e3a\u4e86\u4fdd\u969c <strong>\u516c\u5171\u536b\u751f\u548c\u60a3\u8005\u5b89\u5168<\/strong>\uff0c \u4f9d\u636e <strong>\u6b27\u76df\u6cd5\u89c4 2017\/745 \u7b2c 59 \u6761<\/strong>.<\/p>\n<p>CE \u6807\u5fd7\u8c41\u514d\u4e25\u683c\u9650\u4e8e\u5b58\u5728\u8feb\u5207\u7684\u516c\u5171\u536b\u751f\u9700\u6c42\u6216\u60a3\u8005\u5b89\u5168\u95ee\u9898\u7684\u60c5\u51b5\u3002\u8981\u83b7\u5f97\u8c41\u514d\uff0c\u5236\u9020\u5546\u5fc5\u987b\u8bc1\u660e <strong>\u60a3\u8005\u83b7\u76ca\u663e\u8457<\/strong>\u5e76\u6709\u5b89\u5168\u548c\u6027\u80fd\u6570\u636e\u652f\u6301\uff0c\u8bc1\u660e <strong>\u6ca1\u6709\u66ff\u4ee3\u4ea7\u54c1<\/strong> \u53ef\u4ee5\u5728\u5e02\u573a\u4e0a\u4e70\u5230\u3002<\/p>\n<p>\u66f4\u65b0\u4e2d\u6982\u8ff0\u4e86\u4e24\u79cd\u7c7b\u578b\u7684\u8c41\u514d\u3002 <strong>\u4e2a\u4eba\u8c41\u514d<\/strong> \u9002\u7528\u4e8e\u7d27\u6025\u533b\u7597\u9700\u6c42\u7684\u7279\u5b9a\u60a3\u8005\uff0c\u540c\u65f6 <strong>\u5168\u7403\u8c41\u514d<\/strong> \u6db5\u76d6\u66f4\u5e7f\u6cdb\u7684\u60c5\u51b5\uff0c\u4f46\u4ecd <strong>\u6709\u65f6\u95f4\u9650\u5236\u548c\u8303\u56f4\u9650\u5236<\/strong>\u4f7f\u7528\u8c41\u514d\u8bbe\u5907\u7684\u533b\u7597\u4fdd\u5065\u4e13\u4e1a\u4eba\u5458\u5fc5\u987b\u544a\u77e5\u60a3\u8005\u8be5\u8bbe\u5907\u6ca1\u6709 CE \u6807\u5fd7\uff0c\u83b7\u5f97\u4ed6\u4eec\u7684\u660e\u786e\u540c\u610f\uff0c\u5e76\u62a5\u544a\u4e0e\u8bbe\u5907\u4f7f\u7528\u76f8\u5173\u7684\u4efb\u4f55\u4e8b\u4ef6\u6216\u98ce\u9669\u3002<\/p>\n<p>ANSM \u5c06\u8bc4\u4f30\u7533\u8bf7 <strong>\u5177\u4f53\u60c5\u51b5\u5177\u4f53\u5206\u6790<\/strong>\u786e\u4fdd\u8c41\u514d\u7ee7\u7eed <strong>\u4f8b\u5916<\/strong> \u5e76\u4e14\u4e0d\u8981\u7ed5\u8fc7 <strong>\u6807\u51c6\u76d1\u7ba1\u9014\u5f84<\/strong>\uff0c\u5305\u62ec\u4e34\u5e8a\u8c03\u67e5\u3002<\/p>\n<p>\u5728\u6cd5\u56fd\u4f9b\u5e94\u6216\u4f7f\u7528\u533b\u7597\u5668\u68b0\u7684\u5236\u9020\u5546\u548c\u533b\u7597\u4fdd\u5065\u63d0\u4f9b\u5546\u5e94\u4ed4\u7ec6\u9605\u8bfb ANSM \u7684\u6700\u65b0\u6307\u5357\uff0c\u4ee5\u786e\u4fdd <strong>\u9075\u5b88<\/strong> \u548c <strong>\u9002\u5f53\u7684\u6587\u4ef6<\/strong> \u5f53\u5bfb\u6c42\u51cf\u635f\u65f6\u3002<\/p>\n<p>\u6709\u5173\u8be6\u7ec6\u4fe1\u606f\uff0c\u8bf7\u53c2\u9605 ANSM \u7684\u5b98\u65b9\u51fa\u7248\u7269 <strong>CE \u6807\u5fd7\u8c41\u514d<\/strong>.<\/p>","protected":false},"excerpt":{"rendered":"<p>On January 27, 2025, the National Security Agency of Medicines and Health Products (ANSM) in France issued a key update regarding the process for obtaining CE mark exemptions for medical devices. This regulatory clarification outlines the specific conditions under which manufacturers can seek approval to market medical devices in France without CE certification, which is&#8230;<\/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":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>France ANSM Updates CE Mark Exemption Process | RegASK<\/title>\n<meta name=\"description\" content=\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance &amp; patient safety. 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