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13485\uff09\u3002\u5728\u6b27\u76df\uff0c\u533b\u7597\u5668\u68b0\u9700\u83b7\u5f97CE\u6807\u5fd7\u8bc1\u4e66\uff0c\u8fd9\u662f\u901a\u8fc7\u516c\u544a\u673a\u6784\u5bf9\u4ea7\u54c1\u7b26\u5408\u6b27\u76df\u533b\u7597\u5668\u68b0\u6cd5\u89c4\uff08MDR\u6216IVDR\uff09\u7684\u8bc4\u4f30\u540e\u9881\u53d1\u7684\uff0c\u5141\u8bb8\u4ea7\u54c1\u5728\u6b27\u76df\u5e02\u573a\u81ea\u7531\u6d41\u901a\u3002\u5728\u7f8e\u56fd\uff0cFDA\u901a\u8fc7510(k)\u3001PMA\uff08Premarket Approval\uff09\u6216De Novo\u7b49\u9014\u5f84\u5bf9\u533b\u7597\u5668\u68b0\u8fdb\u884c clearance\u6216approval\uff0c\u5e76\u9881\u53d1\u76f8\u5e94\u7684\u8bb8\u53ef\u8bc1\u4e66\u3002\u6b64\u5916\uff0c\u5176\u4ed6\u5730\u533a\u5982\u65e5\u672c\u3001\u52a0\u62ff\u5927\u7b49\u4e5f\u6709\u5404\u81ea\u7684\u8ba4\u8bc1\u4f53\u7cfb\uff0c\u4f8b\u5982\u65e5\u672c\u7684PMDA\u8ba4\u8bc1\u548c\u52a0\u62ff\u5927\u7684Health Canada\u8bb8\u53ef\u3002\u8fd9\u4e9b\u8bc1\u4e66\u7684\u9002\u7528\u8303\u56f4\u901a\u5e38\u9650\u4e8e\u53d1\u8bc1\u5730\u533a\uff0c\u4f01\u4e1a\u82e5\u60f3\u8fdb\u5165\u5168\u7403\u5e02\u573a\uff0c\u5f80\u5f80\u9700\u8981\u7533\u8bf7\u591a\u56fd\u8ba4\u8bc1\uff0c\u8fd9\u589e\u52a0\u4e86\u8fc7\u7a0b\u7684\u590d\u6742\u6027\u4f46\u6269\u5927\u4e86\u5546\u4e1a\u673a\u4f1a\u3002<\/p>\n<\/p>\n \u4e09\u3001\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u8bc1\u4e66\u7684\u7533\u8bf7\u6d41\u7a0b\u548c\u5173\u952e\u6b65\u9aa4<\/strong><\/p>\n 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13485\uff09\u3002\u5bf9\u4e8e\u67d0\u4e9b\u5730\u533a\uff0c\u5982\u6b27\u76df\uff0c\u4f01\u4e1a\u8fd8\u9700\u9009\u62e9\u4e00\u5bb6\u516c\u544a\u673a\u6784\u8fdb\u884c\u5ba1\u6838\u3002\u7b2c\u4e09\u6b65\u662f\u63d0\u4ea4\u7533\u8bf7\u81f3\u76d1\u7ba1\u673a\u6784\uff0c\u5e76\u652f\u4ed8\u76f8\u5173\u8d39\u7528\u3002\u4e4b\u540e\uff0c\u673a\u6784\u4f1a\u8fdb\u884c\u6280\u672f\u5ba1\u8bc4\uff0c\u53ef\u80fd\u8981\u6c42\u8865\u5145\u8d44\u6599\u6216\u8fdb\u884c\u73b0\u573a\u68c0\u67e5\u3002\u6574\u4e2a\u6d41\u7a0b\u53ef\u80fd\u9700\u8981\u6570\u6708\u5230\u6570\u5e74\uff0c\u53d6\u51b3\u4e8e\u4ea7\u54c1\u590d\u6742\u5ea6\u548c\u5730\u533a\u6cd5\u89c4\u3002\u4f8b\u5982\uff0c\u5728\u4e2d\u56fd\uff0cII\u7c7b\u533b\u7597\u5668\u68b0\u7684\u6ce8\u518c\u5ba1\u8bc4\u65f6\u95f4\u901a\u5e38\u57281-2\u5e74\uff0c\u800cIII\u7c7b\u4ea7\u54c1\u53ef\u80fd\u66f4\u957f\u3002\u6210\u529f\u901a\u8fc7\u540e\uff0c\u673a\u6784\u4f1a\u9881\u53d1\u8bc1\u4e66\uff0c\u4f46\u4f01\u4e1a\u9700\u6301\u7eed\u8fdb\u884c post-market surveillance\uff08\u4e0a\u5e02\u540e\u76d1\u7763\uff09\uff0c\u5305\u62ec\u4e0d\u826f\u4e8b\u4ef6\u62a5\u544a\u548c\u5b9a\u671f\u66f4\u65b0\uff0c\u4ee5\u7ef4\u6301\u8bc1\u4e66\u6709\u6548\u6027\u3002\u6574\u4e2a\u8fc7\u7a0b\u4e2d\uff0c\u4e0e\u4e13\u4e1a\u54a8\u8be2\u673a\u6784\u5408\u4f5c\u53ef\u4ee5\u63d0\u9ad8\u6548\u7387\uff0c\u907f\u514d\u5e38\u89c1\u9519\u8bef\u3002<\/p>\n<\/p>\n \u56db\u3001\u533b\u7597\u5668\u68b0\u8ba4\u8bc1\u8bc1\u4e66\u7684\u91cd\u8981\u6027\u548c\u5bf9\u4f01\u4e1a\u7684\u5f71\u54cd<\/strong><\/p>\n 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