{"id":99605,"date":"2019-05-07T00:00:50","date_gmt":"2019-05-17T08:23:02","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/99605\/"},"modified":"2019-05-17T16:23:05","modified_gmt":"2019-05-17T08:23:05","slug":"21017b753f","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/99605\/","title":{"rendered":"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section style=\"line-height: 1.8;letter-spacing: 0.5px;padding-right: 5px;padding-left: 5px;box-sizing: border-box;font-size: 16px;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"padding-right: 6px;padding-bottom: 8px;box-sizing: border-box;\">\n<section style=\"border-width: 1px;border-style: solid;border-color: rgb(192, 200, 209);box-sizing: border-box;\">\n<section style=\"height: 8px;width: 100%;border-left: 1px solid rgb(192, 200, 209);transform: rotate(-45deg);-webkit-transform: rotate(-45deg);-moz-transform: rotate(-45deg);-o-transform: rotate(-45deg);transform-origin: left top 0px;-webkit-transform-origin: left top 0px;-moz-transform-origin: left top 0px;-o-transform-origin: left top 0px;margin-bottom: 5px;border-top-color: rgb(192, 200, 209);border-right-color: rgb(192, 200, 209);border-bottom-color: rgb(192, 200, 209);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(255, 255, 255);margin: -8px -7px -8px 5px;border-width: 1px;border-style: solid;border-color: rgb(192, 200, 209);padding: 10px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\uff08Unique Device 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style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u4e3a\u4ec0\u4e48UDI\u53ef\u4ee5\u5b9e\u73b0\u5168\u7403\u53ef\u8ffd\u6eaf\uff1f\u5b83\u6709\u4f55\u79cd\u4f18\u52bf\u548c\u4f5c\u7528\uff1f\u6211\u56fd\u5c06\u5982\u4f55\u843d\u5730\u5b9e\u65bd\uff1f\u4ece\u672c\u671f\u5f00\u59cb\uff0c\u6211\u4eec\u63a8\u51fa\u201c\u5173\u6ce8UDI \u5b9e\u73b0\u5168\u7403\u53ef\u8ffd\u6eaf\u201d\u7cfb\u5217\uff0c\u6df1\u5165\u4ecb\u7ecdUDI\u7684\u7f16\u5236\u4e0e\u4f5c\u7528\u3001\u5168\u7403\u5316\u8fdb\u7a0b\u4ee5\u53ca\u672a\u6765\u653f\u7b56\u8d70\u5411\u7b49\uff0c\u656c\u8bf7\u5173\u6ce8\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\uff08UDI\uff09\u662f\u56fd\u9645\u533b\u7597\u5668\u68b0\u76d1\u7ba1\u9886\u57df\u5173\u6ce8\u7684\u70ed\u70b9\uff0c\u662f\u76d1\u7ba1\u624b\u6bb5\u521b\u65b0\u548c\u6548\u80fd\u63d0\u5347\u7684\u53d1\u5c55\u65b9\u5411\u3002UDI\u662f\u91cd\u8981\u7684\u57fa\u7840\u6027\u5de5\u4f5c\uff0c\u5728\u4fe1\u606f\u5316\u3001\u4e92\u8054\u7f51+\u3001\u5927\u6570\u636e\u65f6\u4ee3\uff0c\u5f53\u524d\u76d1\u7ba1\u9886\u57df\u7684\u70ed\u70b9\u5982\u8ffd\u6eaf\u4f53\u7cfb\u5efa\u8bbe\u3001\u771f\u5b9e\u4e16\u754c\u8bc1\u636e\u3001\u533b\u7597\u5668\u68b0\u518d\u8bc4\u4ef7\u7b49\u90fd\u548cUDI\u7d27\u5bc6\u76f8\u5173\uff0c\u5efa\u7acbUDI\u7cfb\u7edf\u662f\u5b9e\u73b0\u667a\u6167\u76d1\u7ba1\u7684\u6709\u6548\u9014\u5f84\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 95%;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;width: 100%;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/3-1558081383.jpeg\" alt=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: 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style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(229, 114, 38);border-top: 2px solid rgb(229, 114, 38);height: 16px;width: 16px;border-right-color: rgb(229, 114, 38);border-bottom-color: rgb(229, 114, 38);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(33, 56, 76);padding-right: 6px;padding-left: 6px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">&nbsp;\u7f8e\u56fd\uff1a\u7387\u5148\u5b9e\u65bdUDI<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">1999\u5e74\uff0c\u7f8e\u56fd\u533b\u5b66\u7814\u7a76\u6240\u53d1\u5e03\u4e86\u300a\u4eba\u975e\u5723\u8d24\u300b\uff08\u300aTo&nbsp;Err&nbsp;is&nbsp;Human\uff0cInstitute&nbsp;of&nbsp;&nbsp;Medicine&nbsp;1999\u300b\uff09\u7684\u7814\u7a76\u62a5\u544a\u3002\u62a5\u544a\u6307\u51fa\uff0c\u9519\u8bef\u5730\u4f7f\u7528\u836f\u7269\u548c\u533b\u7597\u5668\u68b0\u662f\u533b\u7597\u4e8b\u6545\u53d1\u751f\u7684\u4e3b\u8981\u539f\u56e0\u4e4b\u4e00\uff0c<strong style=\"box-sizing: border-box;\"><span style=\"color: rgb(33, 56, 76);box-sizing: border-box;\">\u901a\u8fc7\u6761\u5f62\u7801\u80fd\u591f\u6709\u6548\u5730\u907f\u514d\u548c\u51cf\u5c11\u533b\u7597\u5668\u68b0\u7684\u8bef\u7528<\/span><\/strong>\uff0c\u4ece\u800c\u5927\u5927\u964d\u4f4e\u793e\u4f1a\u6210\u672c\u30022004\u5e74\uff0c\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40\uff08FDA\uff09\u9881\u5e03\u6cd5\u89c4\uff0c\u8981\u6c42\u5728\u836f\u54c1\u6807\u7b7e\u4e0a\u4f7f\u7528\u6761\u5f62\u7801\u3002\u5728\u6cd5\u89c4\u8d77\u8349\u9636\u6bb5\uff0cFDA\u9488\u5bf9\u662f\u5426\u5e94\u5c06\u6b64\u9879\u6cd5\u89c4\u63a8\u5e7f\u81f3\u533b\u7597\u5668\u68b0\u800c\u516c\u5f00\u5f81\u6c42\u610f\u89c1\uff0c\u4f46\u5728\u6cd5\u89c4\u5ba1\u8bae\u8fc7\u7a0b\u4e2d\uff0cFDA\u51b3\u5b9a\u4e0d\u5bf9\u533b\u7597\u5668\u68b0\u5e94\u7528\u6b64\u89c4\u5219\uff0c\u56e0\u4e3a\u533b\u7597\u5668\u68b0\u7f3a\u4e4f\u4e0e\u56fd\u5bb6\u836f\u54c1\u4ee3\u7801\uff08National&nbsp;Drug&nbsp;Code\uff09\u7cfb\u7edf\u76f8\u7c7b\u4f3c\u7684\u6807\u51c6\u548c\u552f\u4e00\u6807\u8bc6\u7cfb\u7edf\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 95%;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;width: 100%;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/8-1558081383.jpeg\" alt=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5c3d\u7ba1\u8be5\u6cd5\u89c4\u51b3\u5b9a\u4e0d\u5bf9\u533b\u7597\u5668\u68b0\u5e94\u7528\u836f\u54c1\u6761\u5f62\u7801\uff0c\u4f46FDA\u5e76\u6ca1\u6709\u653e\u5f03\u5bf9UDI\u7684\u63a2\u7d22\uff0c\u56e0\u4e3aFDA\u8ba4\u8bc6\u5230\uff0c\u552f\u4e00\u6807\u8bc6\u4e0d\u4ec5\u6709\u52a9\u4e8e\u51cf\u5c11\u533b\u7597\u9519\u8bef\u3001\u4fbf\u4e8e\u53ec\u56de\u3001\u8bc6\u522b\u5668\u68b0\u7684\u517c\u5bb9\u6027\u6216\u8fc7\u654f\u53cd\u5e94\uff08\u5982MRI\u548c\u4e73\u80f6\uff09\uff0c\u8fd8\u6709\u52a9\u4e8e\u6539\u5584\u5e93\u5b58\u63a7\u5236\u3001\u5b8c\u5584\u62a5\u9500\u65b9\u5f0f\u5e76\u51cf\u5c11\u5047\u5192\u4ea7\u54c1\u3002\u4e3a\u6b64\uff0cFDA\u79ef\u6781\u5f00\u5c55\u76f8\u5173\u7814\u7a76\uff0c\u63a8\u52a8UDI\u843d\u5730\u5b9e\u65bd\u30022007\u5e74\u300aFDA\u4fee\u6b63\u6848\u300b\uff08\u300aFDA&nbsp;Amendment&nbsp;Act&nbsp;of&nbsp;2007\u300b\uff09\u786e\u7acb\u4e86\u5b9e\u65bdUDI\u7cfb\u7edf\u7684\u7acb\u6cd5\u4f9d\u636e\uff1b2012\u5e74\u300aFDA\u5b89\u5168\u4e0e\u521b\u65b0\u6cd5\u6848\u300b\uff08\u300aFDA&nbsp;Safety&nbsp;and&nbsp;Innovation&nbsp;Act\u300b\uff09\u660e\u786e\u4e86UDI\u7cfb\u7edf\u5b9e\u65bd\u7684\u65f6\u95f4\u6846\u67b6\uff1b2013\u5e749\u6708FDA\u53d1\u5e03\u300a\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u7cfb\u7edf\u89c4\u7ae0\u300b\uff0c\u660e\u786e\u8981\u6c42\u901a\u8fc77\u5e74\u65f6\u95f4\u6309\u7167\u4ea7\u54c1\u98ce\u9669\u7b49\u7ea7\u5206\u9636\u6bb5\u9010\u6b65\u5b9e\u65bdUDI\uff0c\u76f4\u5230\u6240\u6709\u4ea7\u54c1\u5168\u8986\u76d6\u3002\u5176\u95f4\uff0cFDA\u8fd8\u53d1\u5e03\u4e86\u591a\u4e2a\u6307\u5357\uff0c\u6307\u5bfc\u4f01\u4e1a\u7b26\u5408\u89c4\u7ae0\u8981\u6c42\uff0c\u5e76\u8c03\u6574\u4e86\u90e8\u5206\u7c7b\u578b\u4ea7\u54c1\u7684\u5b9e\u65bd\u65e5\u671f\u3002\u76ee\u524d\uff0c\u7f8e<strong style=\"box-sizing: border-box;\"><span style=\"color: rgb(33, 56, 76);box-sizing: border-box;\">\u56fd\u7b2c\u4e09\u7c7b\u548c\u7b2c\u4e8c\u7c7b\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5df2\u7ecf\u5168\u90e8\u5b9e\u65bdUDI\uff0c\u7b2c\u4e00\u7c7b\u548c\u672a\u5206\u7c7b\u533b\u7597\u5668\u68b0\u5c06\u4e8e2020\u5e749\u6708\u8d77\u5b9e\u65bd\u3002<\/span><\/strong><\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">\u5728\u5b9e\u65bdUDI\u8fc7\u7a0b\u4e2d\uff0cFDA\u6210\u7acb\u4e86\u4e13\u95e8\u7684UDI\u5c0f\u7ec4\uff0c\u5e76\u5efa\u7acb\u4e86UDI\u54a8\u8be2\u7cfb\u7edf\uff08UDI&nbsp;Helpdesk\uff09\uff0c\u4ee5\u89e3\u7b54\u4f01\u4e1a\u5728\u5b9e\u65bd\u4e2d\u9047\u5230\u7684\u76f8\u5173\u95ee\u9898\u3002FDA\u57282013\u5e749\u6708\u6cd5\u89c4\u53d1\u5e03\u65f6\u5f00\u653e\u4e86\u6570\u636e\u5e93\u4e0a\u4f20\u529f\u80fd\uff0c\u5e76\u4e8e2015\u5e745\u6708\u5bf9\u516c\u4f17\u5f00\u653e\u3002\u622a\u81f3\u4eca\u5e742\u6708\uff0c\u8be5\u6570\u636e\u5e93\u5df2\u7ecf\u6709\u8d85\u8fc7200\u4e07\u6761\u4e3b\u6570\u636e\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(229, 114, 38);border-top: 2px solid rgb(229, 114, 38);height: 16px;width: 16px;border-right-color: rgb(229, 114, 38);border-bottom-color: rgb(229, 114, 38);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(33, 56, 76);padding-right: 6px;padding-left: 6px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u6b27\u76df\uff1a\u5efa\u7acb\u6570\u636e\u5e93\u5927\u5e73\u53f0<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">2013\u5e744\u6708\uff0c\u6b27\u76df\u53d1\u5e03\u4e86\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\u7cfb\u7edf\u901a\u7528\u6846\u67b6\u7684\u5efa\u8bae\uff0c\u6b32\u5728\u6b27\u76df\u8303\u56f4\u5185\u5b9e\u65bdUDI\u7cfb\u7edf\u30022017\u5e745\u6708\uff0c\u6b27\u76df\u53d1\u5e03\u533b\u7597\u5668\u68b0\u548c\u4f53\u5916\u8bca\u65ad\u8bd5\u5242\u6cd5\u89c4\uff0c\u89c4\u5b9a<strong style=\"box-sizing: border-box;\"><span style=\"color: rgb(33, 56, 76);box-sizing: border-box;\">\u53ea\u6709\u5e26UDI\u7684\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u624d\u53ef\u4ee5\u5408\u6cd5\u8fdb\u5165\u6b27\u76df\u5e02\u573a\u5e76\u81ea\u7531\u6d41\u901a\u3002<\/span><\/strong>\u6839\u636e\u6cd5\u89c4\u8981\u6c42\uff0c\u6b27\u76df\u5c06\u4ece2021\u5e74\u8d77\uff0c\u6309\u7167\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u7684\u7c7b\u578b\u548c\u98ce\u9669\u7b49\u7ea7\uff0c\u901a\u8fc76\u5e74\u65f6\u95f4\u9010\u6b65\u5b9e\u65bdUDI\uff0c\u76f4\u81f3\u5168\u54c1\u79cd\u8986\u76d6\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 95%;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;width: 100%;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/6-1558081384.jpeg\" alt=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u7f8e\u56fd\u7684UDI\u7cfb\u7edf\u6570\u636e\u5e93\u662f\u5355\u4e00\u7684\u6a21\u5757\uff0c\u800c\u6b27\u76df\u5c06\u5efa\u7acb\u7684\u201c\u6b27\u76df\u533b\u7597\u5668\u68b0\u6570\u636e\u5e93\uff08EudaMed\uff09\u201d\u5219\u662f\u4e00\u4e2a\u5927\u5e73\u53f0\uff0c\u8986\u76d6\u533b\u7597\u5668\u68b0\u6574\u4e2a\u751f\u547d\u5468\u671f\u7684\u591a\u4e2a\u9886\u57df\uff0c\u9700\u591a\u65b9\u53c2\u4e0e\u6570\u636e\u7ef4\u62a4\u3001\u591a\u7528\u6237\u6743\u9650\u7ba1\u7406\uff08\u76d1\u7ba1\u3001\u4f01\u4e1a\u3001\u516c\u4f17\u3001\u7b2c\u4e09\u65b9\u8ba4\u8bc1\u673a\u6784\uff09\uff0c\u800cUDI\u6570\u636e\u5e93\u4ec5\u4ec5\u662f\u5176\u4e2d\u7684\u4e00\u4e2a\u90e8\u5206\u3002\u4e0e\u7f8e\u56fd\u4ec5\u8981\u6c42\u4f01\u4e1a\u8f93\u5165\u548c\u66f4\u65b0\u6570\u636e\u76f8\u6bd4\uff0c\u6b27\u76df\u6570\u636e\u5e93\u7cfb\u7edf\u7684\u53c2\u4e0e\u65b9\u66f4\u591a\uff0c\u529f\u80fd\u548c\u9884\u671f\u6548\u679c\u66f4\u597d\u3002\u4f46\u76f8\u5e94\u5730\uff0c\u6b27\u76df\u4e5f\u5c06\u4e3a\u6b64\u4ed8\u51fa\u66f4\u9ad8\u7684\u7cfb\u7edf\u5efa\u8bbe\u548c\u7ef4\u62a4\u6210\u672c\uff0c\u6570\u636e\u5e93\u5efa\u8bbe\u96be\u5ea6\u66f4\u5927\u3002\u5f53\u524d\uff0c\u6570\u636e\u5e93\u8fd8\u5728\u5efa\u8bbe\u4e2d\uff0c\u9884\u8ba1\u4e8e2020\u5e743\u670826\u65e5\u4ea4\u4ed8\u4f7f\u7528\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(229, 114, 38);border-top: 2px solid rgb(229, 114, 38);height: 16px;width: 16px;border-right-color: rgb(229, 114, 38);border-bottom-color: rgb(229, 114, 38);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(33, 56, 76);padding-right: 6px;padding-left: 6px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">\u65e5\u672c\uff1a\u4ee5\u901a\u77e5\u5f62\u5f0f\u63d0\u51fa\u8981\u6c42<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u81ea2002\u5e74\u8d77\uff0c\u6bcf\u5e74\u4f1a\u5bf9\u533b\u7597\u5668\u68b0\u7684\u4fe1\u606f\u5316\u8fdb\u5c55\u60c5\u51b5\u8fdb\u884c\u8c03\u67e5\u30022007\u5e746\u6708\uff0c\u65e5\u672c\u539a\u751f\u52b3\u52a8\u7701\u63a8\u884c\u6cd5\u89c4\u6539\u9769\uff0c\u63a8\u8fdb3\u5e74\u8ba1\u5212\uff0c\u5e76\u4e8e2008\u5e743\u6708\u53d1\u5e03\u300a\u5173\u4e8e\u5bf9\u533b\u7597\u5668\u68b0\u7b49\u6761\u5f62\u7801\u663e\u793a\u5b9e\u65bd\u7684\u901a\u77e5\u300b\uff0c\u4e3b\u8981\u76ee\u7684\u662f\u63d0\u9ad8\u7269\u6d41\u548c\u533b\u4fdd\u7ed3\u7b97\u6548\u7387\u3002\u901a\u77e5\u53d1\u5e03\u540e3\u5e74\u65f6\u95f4\u5185\uff0c\u65e5\u672c\u6309\u7167\u533b\u7597\u5668\u68b0\u98ce\u9669\u7b49\u7ea7\u9010\u6b65\u63a8\u8fdb\uff0c\u5e76\u7531\u533b\u7597\u4fe1\u606f\u7cfb\u7edf\u5f00\u53d1\u4e2d\u5fc3\u5efa\u7acb\u4e86\u6570\u636e\u5e93\uff0c\u767b\u8bb0\u4e0e\u533b\u7597\u5668\u68b0\u6761\u5f62\u7801\u76f8\u5173\u8054\u7684\u4fe1\u606f\u3002\u6839\u636e2018\u5e74\u65e5\u672c\u56fd\u5185\u8c03\u7814\u663e\u793a\uff0c\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u5916\u7bb1\u7684\u8d4b\u7801\u7387\u5df2\u8fbe\u523096%\uff0c\u5355\u4e2a\u533b\u7597\u5668\u68b0\u5305\u88c5\u7684\u8d4b\u7801\u7387\u4e3a88%\uff0c\u6570\u636e\u5e93\u5b57\u6bb5\u4e0a\u4f20\u7387\u4e3a77%\uff0c\u6570\u636e\u5e93\u5b57\u6bb5\u7ea6\u4e3a100\u4e07\u6761\u3002\u503c\u5f97\u6ce8\u610f\u7684\u662f\uff0c\u65e5\u672c\u662f\u4ee5\u901a\u77e5\u7684\u5f62\u5f0f\u63d0\u51fa\u7684UDI\u76f8\u5173\u8981\u6c42\uff0c\u4e3b\u8981\u662f\u9760\u914d\u9001\u3001\u9500\u552e\u548c\u533b\u4fdd\u62a5\u9500\u7ed3\u7b97\u7b49\u540e\u65b9\u63a8\u52a8\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-bottom: 10px;text-align: center;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: middle;padding-left: 6px;box-sizing: border-box;\">\n<section style=\"margin-left: -6px;margin-bottom: -9px;border-left: 2px solid rgb(229, 114, 38);border-top: 2px solid rgb(229, 114, 38);height: 16px;width: 16px;border-right-color: rgb(229, 114, 38);border-bottom-color: rgb(229, 114, 38);box-sizing: border-box;\"><\/section>\n<section style=\"background-color: rgb(33, 56, 76);padding-right: 6px;padding-left: 6px;color: rgb(255, 255, 255);box-sizing: border-box;\">\n<p style=\"box-sizing: border-box;\">&nbsp;\u5176\u4ed6\u56fd\u5bb6\u548c\u5730\u533a\u8fdb\u5c55\u60c5\u51b5<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\"><br style=\"box-sizing: border-box;\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">2012\u5e74\uff0c&nbsp;IMDRF\u521b\u5efa\u6210\u7acb\uff0c\u5e76\u4e8e\u540c\u5e74\u6210\u7acbUDI\u5de5\u4f5c\u7ec4\u30022013\u5e74\uff0cIMDRF\u53d1\u5e03\u4e86\u300aUDI\u7cfb\u7edf\u6307\u5357\u300b\uff0c\u8fd9\u662f\u5173\u4e8eUDI\u7cfb\u7edf\u7684\u6846\u67b6\u6027\u6587\u4ef6\u30022017\u5e749\u6708\uff0cIMDRF\u7ba1\u7406\u59d4\u5458\u4f1a\u7acb\u9879\u6279\u51c6\u4e86\u300aIMDRF&nbsp;UDI\u5e94\u7528\u6307\u5357\u300b\uff0c\u8fd9\u662f\u5bf92013\u5e74\u7cfb\u7edf\u6307\u5357\u5728\u5b9e\u65bd\u5c42\u9762\u7684\u7ec6\u5316\uff0c\u5176\u6700\u7ec8\u6587\u4ef6\u5728\u4eca\u5e743\u6708IMDRF\u83ab\u65af\u79d1\u4f1a\u8bae\u4e0a\u83b7\u5f97\u901a\u8fc7\u3002<\/p>\n<p style=\"white-space: normal;box-sizing: border-box;\">&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 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\u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-top: 10px;margin-bottom: 10px;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;box-sizing: border-box;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/7-1558081385.jpeg\" alt=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<section style=\"box-sizing: border-box;\" >\n<section style=\"margin-top: 10px;margin-right: 0%;margin-left: 0%;box-sizing: border-box;\">\n<section style=\"display: inline-block;vertical-align: bottom;width: 12%;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"text-align: center;margin-right: 0%;margin-left: 0%;box-sizing: border-box;\">\n<section style=\"max-width: 100%;vertical-align: middle;display: inline-block;line-height: 0;width: 80%;box-sizing: border-box;\"><img class=\"raw-image\"     style=\"vertical-align: middle;width: 100%;box-sizing: border-box;\" width=\"100%\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2019\/05\/9-1558081385.gif\" alt=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\" title=\"\u5173\u6ce8UDI \u2460 | \u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6 \u5168\u7403\u5316\u8fdb\u7a0b\u626b\u63cf\"  \/><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"display: inline-block;vertical-align: bottom;width: 88%;padding-left: 10px;box-sizing: border-box;\">\n<section style=\"box-sizing: border-box;\" >\n<section style=\"box-sizing: border-box;\">\n<section style=\"font-size: 15px;box-sizing: border-box;\">\n<p style=\"white-space: normal;box-sizing: border-box;\">\u66f4\u591a\u7cbe\u5f69\uff0c\u5c3d\u5728\u4e2d\u56fd\u98df\u54c1\u836f\u54c1\u7f51\u3002<\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u533b\u7597\u5668\u68b0\u552f\u4e00\u6807\u8bc6\uff08Unique Device Identification\uff0c\u7f29\u5199UDI\uff09\u662f\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u7684\u7535\u5b50\u8eab 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