\u533b\u7597\u5668\u68b0\u7684CE\u8ba4\u8bc1\u662f\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u6761\u4ef6\uff0c\u8fd9\u4e00\u8ba4\u8bc1\u6807\u5fd7\u7740\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u76f8\u5173\u6cd5\u89c4\u548c\u6807\u51c6\u7684\u8981\u6c42\u3002<\/p>\n
\u5bf9\u4e8e\u5236\u9020\u5546\u800c\u8a00\uff0c\u7406\u89e3CE\u8ba4\u8bc1\u7684\u6d41\u7a0b\u3001\u8981\u6c42\u548c\u91cd\u8981\u6027\u81f3\u5173\u91cd\u8981\uff0c\u5b83\u4e0d\u4ec5\u6d89\u53ca\u6cd5\u5f8b\u5408\u89c4\u6027\uff0c\u8fd8\u76f4\u63a5\u5f71\u54cd\u4ea7\u54c1\u7684\u5e02\u573a\u7ade\u4e89\u529b\u3002<\/p>\n<\/p>\n
1. \u533b\u7597\u5668\u68b0CE\u8ba4\u8bc1\u6982\u8ff0<\/strong><\/p>\n CE\u8ba4\u8bc1\u662f\u6b27\u76df\u5bf9\u533b\u7597\u5668\u68b0\u7684\u5f3a\u5236\u6027\u8ba4\u8bc1\u4f53\u7cfb\uff0c\u65e8\u5728\u786e\u4fdd\u4ea7\u54c1\u5728\u5b89\u5168\u6027\u3001\u6027\u80fd\u548c\u8d28\u91cf\u65b9\u9762\u8fbe\u5230\u9ad8\u6807\u51c6\u3002<\/p>\n \u6839\u636e\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\uff09\u548c\u4f53\u5916\u8bca\u65ad\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08IVDR\uff09\uff0c\u6240\u6709\u9500\u5f80\u6b27\u6d32\u7ecf\u6d4e\u533a\u7684\u533b\u7597\u5668\u68b0\u5fc5\u987b\u83b7\u5f97CE\u6807\u5fd7\uff0c\u5426\u5219\u65e0\u6cd5\u4e0a\u5e02\u9500\u552e\u3002<\/p>\n \u8fd9\u4e00\u8ba4\u8bc1\u8fc7\u7a0b\u6d89\u53ca\u591a\u4e2a\u6b65\u9aa4\uff0c\u5305\u62ec\u4ea7\u54c1\u5206\u7c7b\u3001\u6280\u672f\u6587\u4ef6\u51c6\u5907\u3001\u7b26\u5408\u6027\u8bc4\u4f30\u4ee5\u53ca\u516c\u544a\u673a\u6784\u5ba1\u6838\uff0c\u5177\u4f53\u53d6\u51b3\u4e8e\u4ea7\u54c1\u7684\u98ce\u9669\u7b49\u7ea7\u3002<\/p>\n<\/p>\n 2. CE\u8ba4\u8bc1\u7684\u6cd5\u5f8b\u4f9d\u636e\u548c\u91cd\u8981\u6027<\/strong><\/p>\n \u6b27\u76df\u901a\u8fc7MDR\uff08\u6cd5\u89c42017\/745\uff09\u548cIVDR\uff08\u6cd5\u89c42017\/746\uff09\u786e\u7acb\u4e86\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\u6846\u67b6\uff0c\u8fd9\u4e9b\u6cd5\u89c4\u4e8e2021\u5e74\u5168\u9762\u5b9e\u65bd\uff0c\u53d6\u4ee3\u4e86\u4e4b\u524d\u7684\u6307\u4ee4\u3002<\/p>\n CE\u8ba4\u8bc1\u4e0d\u4ec5\u662f\u6cd5\u5f8b\u8981\u6c42\uff0c\u8fd8\u589e\u5f3a\u4e86\u6d88\u8d39\u8005\u548c\u533b\u7597\u4e13\u4e1a\u4eba\u58eb\u5bf9\u4ea7\u54c1\u7684\u4fe1\u4efb\uff0c\u56e0\u4e3a\u5b83\u8bc1\u660e\u4ea7\u54c1\u7ecf\u8fc7\u72ec\u7acb\u8bc4\u4f30\uff0c\u7b26\u5408\u6b27\u6d32\u5065\u5eb7\u3001\u5b89\u5168\u548c\u73af\u4fdd\u6807\u51c6\u3002<\/p>\n \u6b64\u5916\uff0c\u62e5\u6709CE\u8ba4\u8bc1\u7684\u533b\u7597\u5668\u68b0\u53ef\u4ee5\u5728\u6b27\u76df\u6210\u5458\u56fd\u81ea\u7531\u6d41\u901a\uff0c\u65e0\u9700\u91cd\u590d\u8ba4\u8bc1\uff0c\u8fd9\u7b80\u5316\u4e86\u5e02\u573a\u51c6\u5165\u5e76\u964d\u4f4e\u4e86\u8d38\u6613\u58c1\u5792\u3002<\/p>\n<\/p>\n 3. \u533b\u7597\u5668\u68b0\u7684\u5206\u7c7b\u548c\u8ba4\u8bc1\u6d41\u7a0b<\/strong><\/p>\n \u533b\u7597\u5668\u68b0\u6839\u636e\u98ce\u9669\u6c34\u5e73\u5206\u4e3aI\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u548cIII\u7c7b\uff0c\u5176\u4e2dI\u7c7b\u98ce\u9669\u6700\u4f4e\uff0cIII\u7c7b\u6700\u9ad8\uff0c\u8ba4\u8bc1\u6d41\u7a0b\u56e0\u5206\u7c7b\u800c\u5f02\u3002<\/p>\n \u5bf9\u4e8e\u4f4e\u98ce\u9669\u4ea7\u54c1\uff08\u5982\u67d0\u4e9bI\u7c7b\u5668\u68b0\uff09\uff0c\u5236\u9020\u5546\u53ef\u81ea\u884c\u8fdb\u884c\u7b26\u5408\u6027\u58f0\u660e\uff0c\u800c\u4e2d\u9ad8\u98ce\u9669\u4ea7\u54c1\uff08\u5982IIa\u3001IIb\u548cIII\u7c7b\uff09\u5fc5\u987b\u901a\u8fc7\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u7684\u5ba1\u6838\u3002<\/p>\n \u5178\u578b\u6d41\u7a0b\u5305\u62ec\uff1a\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\u3001\u51c6\u5907\u6280\u672f\u6587\u4ef6\uff08\u542b\u8bbe\u8ba1\u3001\u5236\u9020\u548c\u6d4b\u8bd5\u6570\u636e\uff09\u3001\u5b9e\u65bd\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08\u5982ISO 13485\uff09\u3001\u8fdb\u884c\u4e34\u5e8a\u8bc4\u4f30\uff08\u5982\u679c\u9700\u8981\uff09\u3001\u63d0\u4ea4\u516c\u544a\u673a\u6784\u5ba1\u6838\uff0c\u4ee5\u53ca\u6700\u7ec8\u7b7e\u7f72\u7b26\u5408\u6027\u58f0\u660e\u548c\u9644\u52a0CE\u6807\u5fd7\u3002<\/p>\n<\/p>\n 4. \u6280\u672f\u6587\u4ef6\u548c\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\u7684\u8981\u6c42<\/strong><\/p>\n \u6280\u672f\u6587\u4ef6\u662fCE\u8ba4\u8bc1\u7684\u6838\u5fc3\uff0c\u5b83\u5fc5\u987b\u8be6\u7ec6\u8bb0\u5f55\u4ea7\u54c1\u7684\u8bbe\u8ba1\u3001\u5236\u9020\u3001\u6027\u80fd\u6d4b\u8bd5\u548c\u98ce\u9669\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u7b26\u5408\u6b27\u76df\u6cd5\u89c4\u3002<\/p>\n \u6587\u4ef6\u5e94\u5305\u62ec\u4ea7\u54c1\u63cf\u8ff0\u3001\u89c4\u683c\u3001\u6807\u7b7e\u3001\u4f7f\u7528\u8bf4\u660e\u3001\u4e34\u5e8a\u6570\u636e\uff08\u5bf9\u4e8e\u4e2d\u9ad8\u98ce\u9669\u4ea7\u54c1\uff09\u3001\u4ee5\u53ca\u7b26\u5408\u76f8\u5173 harmonized \u6807\u51c6\u7684\u8bc1\u660e\u3002<\/p>\n \u540c\u65f6\uff0c\u5236\u9020\u5546\u5fc5\u987b\u5efa\u7acb\u5e76\u7ef4\u62a4\u8d28\u91cf\u7ba1\u7406\u4f53\u7cfb\uff08QMS\uff09\uff0c\u901a\u5e38\u57fa\u4e8eISO 13485\u6807\u51c6\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u5728\u6574\u4e2a\u751f\u547d\u5468\u671f\u4e2d\u7684\u4e00\u81f4\u6027\u548c\u53ef\u8ffd\u6eaf\u6027\u3002<\/p>\n \u516c\u544a\u673a\u6784\u4f1a\u5ba1\u6838QMS\u548c\u6280\u672f\u6587\u4ef6\uff0c\u4ee5\u9a8c\u8bc1\u5408\u89c4\u6027\u3002<\/p>\n<\/p>\n 5. \u516c\u544a\u673a\u6784\u7684\u4f5c\u7528\u548c\u9009\u62e9<\/strong><\/p>\n \u516c\u544a\u673a\u6784\u662f\u7ecf\u6b27\u76df\u6210\u5458\u56fd\u6307\u5b9a\u5e76\u6388\u6743\u7684\u72ec\u7acb\u7ec4\u7ec7\uff0c\u8d1f\u8d23\u5ba1\u6838\u4e2d\u9ad8\u98ce\u9669\u533b\u7597\u5668\u68b0\u7684\u7b26\u5408\u6027\u8bc4\u4f30\u3002<\/p>\n \u5b83\u4eec\u6267\u884c\u5ba1\u6838\u3001\u6d4b\u8bd5\u548c\u8ba4\u8bc1\u5de5\u4f5c\uff0c\u786e\u4fdd\u4ea7\u54c1\u6ee1\u8db3MDR\u6216IVDR\u7684\u8981\u6c42\uff0c\u5236\u9020\u5546\u5fc5\u987b\u9009\u62e9\u4e0e\u4ea7\u54c1\u7c7b\u578b\u76f8\u5339\u914d\u7684\u516c\u544a\u673a\u6784\u3002<\/p>\n \u9009\u62e9\u65f6\uff0c\u5e94\u8003\u8651\u673a\u6784\u7684 expertise\u3001\u58f0\u8a89\u548c\u5ba1\u6838\u5468\u671f\uff0c\u56e0\u4e3a\u4e0d\u5f53\u9009\u62e9\u53ef\u80fd\u5bfc\u81f4 delays \u6216\u8ba4\u8bc1\u5931\u8d25\u3002<\/p>\n<\/p>\n 6. \u4e34\u5e8a\u8bc4\u4f30\u548c\u4e0a\u5e02\u540e\u76d1\u7763<\/strong><\/p>\n \u4e34\u5e8a\u8bc4\u4f30\u662fCE\u8ba4\u8bc1\u7684\u5173\u952e\u90e8\u5206\uff0c\u5c24\u5176\u5bf9\u4e8e\u4e2d\u9ad8\u98ce\u9669\u5668\u68b0\uff0c\u5b83\u6d89\u53ca\u6536\u96c6\u548c\u5206\u6790\u4e34\u5e8a\u6570\u636e\u4ee5\u8bc1\u660e\u4ea7\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u3002<\/p>\n \u6839\u636eMDR\uff0c\u5236\u9020\u5546\u5fc5\u987b\u8fdb\u884c\u6301\u7eed\u7684\u4e0a\u5e02\u540e\u76d1\u7763\uff08PMS\uff09\uff0c\u5305\u62ec\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u3001\u5b9a\u671f\u5b89\u5168\u66f4\u65b0\u548c\u73b0\u573a\u5b89\u5168\u7ea0\u6b63\u63aa\u65bd\uff0c\u4ee5\u786e\u4fdd\u6301\u7eed\u5408\u89c4\u3002<\/p>\n \u8fd9\u6709\u52a9\u4e8e\u53ca\u65f6\u53d1\u73b0\u548c mitigate \u98ce\u9669\uff0c\u4fdd\u62a4\u60a3\u8005\u5b89\u5168\uff0c\u5e76\u7ef4\u62a4CE\u8ba4\u8bc1\u7684\u6709\u6548\u6027\u3002<\/p>\n<\/p>\n 7. CE\u8ba4\u8bc1\u7684\u6311\u6218\u548c\u5e38\u89c1\u95ee\u9898<\/strong><\/p>\n \u5236\u9020\u5546\u5e38\u9762\u4e34\u6311\u6218\uff0c\u5982\u6cd5\u89c4\u53d8\u5316\uff08\u5982MDR\u8fc7\u6e21\u671f\uff09\u3001\u6280\u672f\u6587\u4ef6\u51c6\u5907\u4e0d\u8db3\u3001\u4e34\u5e8a\u6570\u636e\u8981\u6c42\u63d0\u9ad8\uff0c\u4ee5\u53ca\u516c\u544a\u673a\u6784\u8d44\u6e90\u7d27\u5f20\u5bfc\u81f4\u7684\u5ba1\u6838\u5ef6\u8fdf\u3002<\/p>\n \u5e38\u89c1\u95ee\u9898\u5305\u62ec\u8bef\u89e3\u4ea7\u54c1\u5206\u7c7b\u3001\u5ffd\u89c6\u8bed\u8a00\u8981\u6c42\uff08\u6807\u7b7e\u548c\u6587\u4ef6\u9700\u7528\u6b27\u76df\u5b98\u65b9\u8bed\u8a00\uff09\u3001\u6216\u672a\u80fd\u53ca\u65f6\u66f4\u65b0\u8ba4\u8bc1\u4ee5\u53cd\u6620\u8bbe\u8ba1\u53d8\u66f4\u3002<\/p>\n \u89e3\u51b3\u8fd9\u4e9b requires \u63d0\u524d\u89c4\u5212\u3001\u4e13\u4e1a\u54a8\u8be2\u548c\u6301\u7eed\u6559\u80b2\uff0c\u4ee5\u907f\u514d\u8ba4\u8bc1\u5931\u8d25\u6216\u5e02\u573a\u64a4\u56de\u3002<\/p>\n<\/p>\n 8. CE\u8ba4\u8bc1\u4e0e\u5176\u4ed6\u56fd\u9645\u8ba4\u8bc1\u7684\u6bd4\u8f83<\/strong><\/p>\n CE\u8ba4\u8bc1\u7c7b\u4f3c\u4e8e\u5176\u4ed6\u5730\u533a\u7684\u8ba4\u8bc1\uff0c\u5982\u7f8e\u56fd\u7684FDA\u6279\u51c6\u6216\u4e2d\u56fd\u7684NMPA\u6ce8\u518c\uff0c\u4f46\u5404\u6709\u4fa7\u91cd\uff1aCE\u5f3a\u8c03\u7b26\u5408\u6b27\u76df\u6cd5\u89c4\uff0c\u800cFDA\u66f4\u6ce8\u91cd pre-market \u5ba1\u6838\u3002<\/p>\n CE\u8ba4\u8bc1\u57fa\u4e8e harmonized \u6807\u51c6\uff0c\u800c\u5176\u4ed6\u4f53\u7cfb\u53ef\u80fd\u5f15\u7528\u672c\u5730\u6807\u51c6\uff0c\u5236\u9020\u5546\u82e5 targeting \u591a\u4e2a\u5e02\u573a\uff0c\u9700\u540c\u65f6\u6ee1\u8db3\u4e0d\u540c\u8981\u6c42\uff0c\u589e\u52a0\u590d\u6742\u6027\u3002<\/p>\n \u7136\u800c\uff0cCE\u8ba4\u8bc1\u7684\u4e92\u8ba4\u534f\u8bae\uff08\u5982\u4e0e\u67d0\u4e9b\u56fd\u5bb6\uff09\u53ef\u7b80\u5316\u90e8\u5206\u6d41\u7a0b\uff0c\u4f46\u603b\u4f53\u4ecd\u9700\u72ec\u7acb\u5904\u7406\u3002<\/p>\n<\/p>\n 9. \u672a\u6765\u8d8b\u52bf\u548c\u5efa\u8bae<\/strong><\/p>\n \u968f\u7740\u533b\u7597\u6280\u672f\u53d1\u5c55\u548c\u6cd5\u89c4\u6f14\u8fdb\uff0cCE\u8ba4\u8bc1\u5c06\u66f4\u52a0\u6ce8\u91cd\u6570\u5b57\u5316\u8f6c\u578b\u3001\u7f51\u7edc\u5b89\u5168\u548c\u53ef\u6301\u7eed\u6027\uff0c\u4f8b\u5982MDR\u5bf9\u8f6f\u4ef6\u5373\u533b\u7597\u8bbe\u5907\uff08SaMD\uff09\u7684\u8981\u6c42\u66f4\u4e25\u683c\u3002<\/p>\n \u5efa\u8bae\u5236\u9020\u5546\u5c3d\u65e9\u542f\u52a8\u8ba4\u8bc1\u6d41\u7a0b\u3001\u6295\u8d44\u4e8e robust QMS\u3001\u4e0e\u4e13\u4e1a\u987e\u95ee\u5408\u4f5c\uff0c\u5e76\u5173\u6ce8\u6b27\u76df\u6570\u636e\u5e93\uff08\u5982EUDAMED\uff09\u7684\u66f4\u65b0\uff0c\u4ee5\u4fdd\u6301\u5408\u89c4\u3002<\/p>\n \u603b\u4e4b\uff0cCE\u8ba4\u8bc1\u662f\u52a8\u6001\u8fc7\u7a0b\uff0c\u9700\u8981\u6301\u7eed\u6295\u5165\u548c\u9002\u5e94\uff0c\u4ee5\u6210\u529f\u8fdb\u5165\u5e76\u7ef4\u6301\u5728\u6b27\u6d32\u5e02\u573a\u3002<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u672c\u6587\u4f5c\u8005\u53ca\u53d1\u5e03\u5e73\u53f0\u4e0d\u627f\u62c5\u56e0\u53c2\u8003\u672c\u6587\u5185\u5bb9\u800c\u4ea7\u751f\u7684\u4efb\u4f55\u8d23\u4efb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":" \u533b\u7597\u5668\u68b0\u7684CE\u8ba4\u8bc1\u662f\u8fdb\u5165\u6b27\u6d32\u5e02\u573a\u7684\u5173\u952e\u51c6\u5165\u6761\u4ef6\uff0c\u8fd9\u4e00\u8ba4\u8bc1\u6807\u5fd7\u7740\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u76f8\u5173\u6cd5\u89c4\u548c\u6807\u51c6\u7684\u8981\u6c42\u3002 \u5bf9\u4e8e\u5236\u9020\u5546\u800c […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[549],"class_list":["post-4225","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-ce"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4225","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=4225"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4225\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4225"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4225"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4225"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}