\u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\uff08\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff09\u662f\u786e\u4fdd\u533b\u7597\u5668\u68b0\u5728\u6b27\u6d32\u5e02\u573a\u5b89\u5168\u6709\u6548\u6d41\u901a\u7684\u5173\u952e\u73af\u8282\uff0c\u8fd9\u4e00\u8fc7\u7a0b\u4e0d\u4ec5\u6d89\u53ca\u6280\u672f\u8bc4\u4f30\uff0c\u8fd8\u6db5\u76d6\u6cd5\u89c4\u5408\u89c4\u6027\u5ba1\u67e5\uff0c\u662f\u5236\u9020\u5546\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u7684\u5fc5\u7ecf\u4e4b\u8def\u3002<\/p>\n<\/p>\n
\u4e00\u3001\u4ec0\u4e48\u662f\u533b\u7597\u5668\u68b0MDR\uff1f\u5176\u6838\u5fc3\u8981\u6c42\u4e0e\u68c0\u9a8c\u91cd\u8981\u6027\u89e3\u6790<\/strong><\/p>\n MDR\u662f\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08Medical Device Regulation\uff09\u7684\u7f29\u5199\uff0c\u5b83\u4e8e2017\u5e74\u53d1\u5e03\uff0c\u5e76\u4e8e2021\u5e74\u6b63\u5f0f\u53d6\u4ee3\u539f\u6709\u7684MDD\uff08\u533b\u7597\u5668\u68b0\u6307\u4ee4\uff09\uff0c\u65e8\u5728\u52a0\u5f3a\u5bf9\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\uff0c\u63d0\u5347\u60a3\u8005\u5b89\u5168\u548c\u900f\u660e\u5ea6\u3002<\/p>\n<\/p>\n MDR\u7684\u6838\u5fc3\u8981\u6c42\u5305\u62ec\u66f4\u4e25\u683c\u7684\u4e34\u5e8a\u8bc1\u636e\u8bc4\u4f30\u3001\u552f\u4e00\u8bbe\u5907\u6807\u8bc6\uff08UDI\uff09\u7cfb\u7edf\u5b9e\u65bd\u3001\u52a0\u5f3a\u4e0a\u5e02\u540e\u76d1\u7763\u4ee5\u53ca\u63d0\u9ad8\u5236\u9020\u5546\u8d23\u4efb\uff0c\u68c0\u9a8c\u8fc7\u7a0b\u6d89\u53ca\u5bf9\u6280\u672f\u6587\u4ef6\u3001\u8d28\u91cf\u4f53\u7cfb\u3001\u4e34\u5e8a\u6570\u636e\u548c\u98ce\u9669\u7ba1\u7406\u7684\u5168\u9762\u5ba1\u6838\uff0c\u4ee5\u786e\u4fdd\u4ea7\u54c1\u7b26\u5408\u65b0\u89c4\u3002<\/p>\n<\/p>\n \u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\u7684\u91cd\u8981\u6027\u5728\u4e8e\uff0c\u5b83\u5e2e\u52a9\u5236\u9020\u5546\u907f\u514d\u5e02\u573a\u51c6\u5165\u969c\u788d\uff0c\u51cf\u5c11\u56e0\u4e0d\u5408\u89c4\u5bfc\u81f4\u7684\u53ec\u56de\u6216\u7f5a\u6b3e\uff0c\u540c\u65f6\u4fdd\u969c\u60a3\u8005\u4f7f\u7528\u5b89\u5168\uff0c\u5bf9\u4e8e\u5168\u7403\u533b\u7597\u5668\u68b0\u884c\u4e1a\u6765\u8bf4\uff0cMDR\u5408\u89c4\u5df2\u6210\u4e3a\u7ade\u4e89\u529b\u7684\u5173\u952e\u6307\u6807\u3002<\/p>\n<\/p>\n \u4e8c\u3001\u533b\u7597\u5668\u68b0MDR\u68c0\u9a8c\u7684\u5173\u952e\u6b65\u9aa4\u4e0e\u6d41\u7a0b\u6307\u5357<\/strong><\/p>\n \u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\u7684\u8fc7\u7a0b\u901a\u5e38\u4ece\u51c6\u5907\u9636\u6bb5\u5f00\u59cb\uff0c\u5236\u9020\u5546\u9700\u9996\u5148\u786e\u5b9a\u4ea7\u54c1\u5206\u7c7b\uff08\u5982I\u7c7b\u3001IIa\u7c7b\u3001IIb\u7c7b\u6216III\u7c7b\uff09\uff0c\u56e0\u4e3a\u4e0d\u540c\u7c7b\u522b\u5bf9\u5e94\u4e0d\u540c\u7684\u5408\u89c4\u8def\u5f84\u548c\u68c0\u9a8c\u6df1\u5ea6\u3002<\/p>\n<\/p>\n \u63a5\u4e0b\u6765\uff0c\u5236\u9020\u5546\u5fc5\u987b\u7f16\u5236\u5b8c\u6574\u7684\u6280\u672f\u6587\u4ef6\uff0c\u5305\u62ec\u4ea7\u54c1\u63cf\u8ff0\u3001\u8bbe\u8ba1\u4fe1\u606f\u3001\u6027\u80fd\u6d4b\u8bd5\u62a5\u544a\u3001\u98ce\u9669\u8bc4\u4f30\u6587\u6863\u4ee5\u53ca\u4e34\u5e8a\u8bc4\u4f30\u62a5\u544a\uff0c\u8fd9\u4e9b\u6587\u4ef6\u9700\u63d0\u4ea4\u7ed9\u516c\u544a\u673a\u6784\uff08Notified Body\uff09\u8fdb\u884c\u5ba1\u6838\uff0c\u516c\u544a\u673a\u6784\u662f\u6b27\u76df\u6388\u6743\u7684\u72ec\u7acb\u7ec4\u7ec7\uff0c\u8d1f\u8d23\u6267\u884cMDR\u68c0\u9a8c\u3002<\/p>\n<\/p>\n \u68c0\u9a8c\u6d41\u7a0b\u8fd8\u5305\u62ec\u8d28\u91cf\u4f53\u7cfb\u5ba1\u6838\uff0c\u4f8b\u5982\u57fa\u4e8eISO 13485\u6807\u51c6\u7684\u8bc4\u4f30\uff0c\u4ee5\u786e\u4fdd\u751f\u4ea7\u6d41\u7a0b\u7b26\u5408MDR\u8981\u6c42\uff0c\u4e00\u65e6\u901a\u8fc7\u68c0\u9a8c\uff0c\u5236\u9020\u5546\u53ef\u83b7\u5f97CE\u6807\u5fd7\uff0c\u5141\u8bb8\u4ea7\u54c1\u5728\u6b27\u76df\u5e02\u573a\u9500\u552e\uff0c\u4f46\u9700\u6ce8\u610f\uff0cMDR\u8981\u6c42\u6301\u7eed\u4e0a\u5e02\u540e\u76d1\u7763\uff0c\u5305\u62ec\u5b9a\u671f\u62a5\u544a\u548c\u66f4\u65b0\u6587\u4ef6\uff0c\u4ee5\u7ef4\u6301\u5408\u89c4\u72b6\u6001\u3002<\/p>\n<\/p>\n \u4e09\u3001MDR\u68c0\u9a8c\u4e2d\u7684\u5e38\u89c1\u6311\u6218\u4e0e\u5e94\u5bf9\u7b56\u7565<\/strong><\/p>\n \u8bb8\u591a\u5236\u9020\u5546\u5728\u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\u65f6\u9762\u4e34\u6311\u6218\uff0c\u4f8b\u5982\u4e34\u5e8a\u6570\u636e\u4e0d\u8db3\u3001UDI\u7cfb\u7edf\u96c6\u6210\u590d\u6742\u6216\u6587\u4ef6\u51c6\u5907\u4e0d\u5145\u5206\uff0c\u8fd9\u4e9b\u53ef\u80fd\u5bfc\u81f4\u5ba1\u6838\u5ef6\u8fdf\u6216\u5931\u8d25\u3002<\/p>\n<\/p>\n \u4e3a\u5e94\u5bf9\u8fd9\u4e9b\u6311\u6218\uff0c\u5236\u9020\u5546\u5e94\u5c3d\u65e9\u542f\u52a8\u5408\u89c4\u9879\u76ee\uff0c\u6295\u8d44\u4e8e\u4e13\u4e1a\u57f9\u8bad\u6216\u54a8\u8be2 services\uff0c\u5e76\u5229\u7528\u6570\u5b57\u5316\u5de5\u5177\u7ba1\u7406\u6587\u6863\u548c\u8ddf\u8e2a\u8fdb\u5ea6\uff0c\u6b64\u5916\uff0c\u4e0e\u516c\u544a\u673a\u6784\u5efa\u7acb\u65e9\u671f\u6c9f\u901a\u53ef\u4ee5\u5e2e\u52a9\u8bc6\u522b\u6f5c\u5728\u95ee\u9898\uff0c\u5e76\u4f18\u5316\u68c0\u9a8c\u6d41\u7a0b\u3002<\/p>\n<\/p>\n \u53e6\u4e00\u4e2a\u5e38\u89c1\u6311\u6218\u662fMDR\u7684\u8fc7\u6e21\u671f\u5b89\u6392\uff0c\u5236\u9020\u5546\u9700\u786e\u4fdd\u5728\u65e7\u6cd5\u89c4\u5931\u6548\u524d\u5b8c\u6210\u8f6c\u6362\uff0c\u907f\u514d\u5e02\u573a\u4e2d\u65ad\uff0c\u901a\u8fc7\u5236\u5b9a\u8be6\u7ec6\u7684\u65f6\u95f4\u8868\u548c\u98ce\u9669\u8bc4\u4f30\uff0c\u53ef\u4ee5\u5e73\u6ed1\u8fc7\u6e21\u5e76\u51cf\u5c11\u4e1a\u52a1\u5f71\u54cd\u3002<\/p>\n<\/p>\n \u56db\u3001MDR\u68c0\u9a8c\u7684\u672a\u6765\u8d8b\u52bf\u4e0e\u884c\u4e1a\u5f71\u54cd<\/strong><\/p>\n \u968f\u7740\u533b\u7597\u6280\u672f\u5feb\u901f\u53d1\u5c55\uff0cMDR\u68c0\u9a8c\u6b63\u671d\u7740\u66f4\u6570\u5b57\u5316\u548c\u900f\u660e\u5316\u7684\u65b9\u5411\u6f14\u8fdb\uff0c\u4f8b\u5982\u5229\u7528\u4eba\u5de5\u667a\u80fd\u8fdb\u884c\u6570\u636e\u5206\u6790\u548c\u8fdc\u7a0b\u5ba1\u6838\uff0c\u8fd9\u63d0\u9ad8\u4e86\u6548\u7387\u4f46\u4e5f\u5e26\u6765\u4e86\u65b0\u7684\u5408\u89c4\u8981\u6c42\u3002<\/p>\n<\/p>\n \u884c\u4e1a\u5f71\u54cd\u65b9\u9762\uff0cMDR\u63a8\u52a8\u4e86\u5168\u7403\u533b\u7597\u5668\u68b0\u6807\u51c6\u7684\u7edf\u4e00\uff0c\u9f13\u52b1\u521b\u65b0 while ensuring safety\uff0c\u5236\u9020\u5546\u5fc5\u987b\u9002\u5e94\u8fd9\u4e9b\u53d8\u5316\uff0c\u901a\u8fc7\u6301\u7eed\u6539\u8fdb\u6765\u4fdd\u6301\u7ade\u4e89\u529b\uff0c\u540c\u65f6\uff0cMDR\u7684\u4e25\u683c\u6027\u53ef\u80fd\u5bfc\u81f4\u5c0f\u4f01\u4e1a\u9762\u4e34\u66f4\u5927\u538b\u529b\uff0c\u56e0\u6b64\u5408\u4f5c\u4e0e\u8d44\u6e90\u5171\u4eab\u5c06\u6210\u4e3a\u5173\u952e\u7b56\u7565\u3002<\/p>\n<\/p>\n \u603b\u4f53\u800c\u8a00\uff0c\u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\u4e0d\u4ec5\u662f\u6cd5\u89c4\u4e49\u52a1\uff0c\u66f4\u662f\u63d0\u5347\u4ea7\u54c1\u8d28\u91cf\u548c\u5e02\u573a\u4fe1\u4efb\u7684\u673a\u4f1a\uff0c\u901a\u8fc7\u6df1\u5165\u7406\u89e3\u548c\u79ef\u6781\u5e94\u5bf9\uff0c\u4f01\u4e1a\u53ef\u4ee5\u6210\u529f\u5bfc\u822a\u8fd9\u4e00\u590d\u6742\u9886\u57df\u3002<\/p>\n<\/p>\n \u514d\u8d23\u58f0\u660e\uff1a\u672c\u6587\u5185\u5bb9\u4ec5\u4f9b\u53c2\u8003\uff0c\u4e0d\u6784\u6210\u4e13\u4e1a\u6cd5\u5f8b\u6216\u533b\u7597\u5efa\u8bae\uff0c\u8bfb\u8005\u5e94\u81ea\u884c\u6838\u5b9e\u4fe1\u606f\u5e76\u54a8\u8be2\u76f8\u5173\u4e13\u5bb6\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":" \u68c0\u9a8c\u533b\u7597\u5668\u68b0MDR\uff08\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff09\u662f\u786e\u4fdd\u533b\u7597\u5668\u68b0\u5728\u6b27\u6d32\u5e02\u573a\u5b89\u5168\u6709\u6548\u6d41\u901a\u7684\u5173\u952e\u73af\u8282\uff0c\u8fd9\u4e00\u8fc7\u7a0b\u4e0d\u4ec5\u6d89\u53ca\u6280\u672f\u8bc4\u4f30\uff0c\u8fd8 […]<\/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":[376],"class_list":["post-4052","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-mdr"],"_links":{"self":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4052","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=4052"}],"version-history":[{"count":0,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=\/wp\/v2\/posts\/4052\/revisions"}],"wp:attachment":[{"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=4052"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=4052"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rohs.ac.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=4052"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}