{"id":9450,"date":"2026-02-09T16:28:54","date_gmt":"2026-02-09T08:28:54","guid":{"rendered":"https:\/\/regask.com\/?p=9450"},"modified":"2026-02-09T16:28:54","modified_gmt":"2026-02-09T08:28:54","slug":"fda%e5%90%af%e5%8a%a8importshield%e8%ae%a1%e5%88%92%ef%bc%8c%e5%8a%a0%e5%bc%ba%e5%af%b9%e8%bf%9b%e5%8f%a3%e9%a3%9f%e5%93%81%e3%80%81%e8%8d%af%e5%93%81%e5%92%8c%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0","status":"publish","type":"post","link":"https:\/\/regask.com\/zh\/fda-launches-importshield-program-to-strengthen-oversight-of-imported-food-drugs-and-medical-devices\/","title":{"rendered":"FDA\u542f\u52a8ImportShield\u8ba1\u5212\u4ee5\u52a0\u5f3a\u76d1\u7ba1\u2026\u2026"},"content":{"rendered":"<p>\u5728 <strong>2026\u5e741\u670821\u65e5<\/strong>\uff0c \u8fd9 <strong>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u7ba1\u7406\u5c40 (FDA)<\/strong> \u5ba3\u5e03\u4e86\u8be5\u9879\u5de5\u4f5c\u7684\u542f\u52a8\u548c\u521d\u6b65\u7ed3\u679c <strong>FDA ImportShield Program (FISP)<\/strong>, \u4e00\u9879\u65e8\u5728\u52a0\u5f3a\u76d1\u7763\u7684\u5168\u56fd\u6027\u5021\u8bae <strong>\u8fdb\u53e3\u836f\u54c1\u3001\u98df\u54c1\u3001\u533b\u7597\u5668\u68b0\u53ca\u76f8\u5173\u4ea7\u54c1<\/strong> \u5728\u7f8e\u56fd\u5165\u5883\u53e3\u5cb8\u3002\u8be5\u8ba1\u5212\u4e8e\u2026\u2026\u5f00\u59cb\u5b9e\u65bd\u3002 <strong>2025\u5e748\u6708,<\/strong> \u9002\u7528\u4e8e\u6240\u6709\u5411\u7f8e\u56fd\u8fdb\u53e3\u53d7 FDA \u76d1\u7ba1\u4ea7\u54c1\u7684\u5b9e\u4f53\u3002.<\/p>\n<div class=\"row\"  id=\"row-727640741\">\n\n\t<div id=\"col-272212968\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\t<div id=\"gap-345394671\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-345394671 {\n  padding-top: 20px;\n}\n<\/style>\n\t<\/div>\n\t\n<h2>\u66f4\u65b0\u6458\u8981<\/h2>\n\t<div id=\"gap-315844104\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-315844104 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9 <strong>FDA ImportShield\u8ba1\u5212<\/strong> \u901a\u8fc7\u5c06\u533a\u57df\u56e2\u961f\u6574\u5408\u5230\u4e00\u4e2a\u7edf\u4e00\u7684\u56fd\u5bb6\u6846\u67b6\u4e2d\uff0c\u96c6\u4e2d\u7ba1\u7406\u8be5\u673a\u6784\u7684\u8fdb\u53e3\u5ba1\u67e5\u4e1a\u52a1\u3002\u8fd9\u79cd\u7edf\u4e00\u7684\u65b9\u6cd5\u73b0\u5728\u9002\u7528\u4e8e <strong>\u6240\u6709\u53d7\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u76d1\u7ba1\u7684\u8fdb\u53e3\u5546\u54c1\uff0c\u5747\u9700\u7ecf\u7531\u7f8e\u56fd\u6240\u6709\u5165\u5883\u53e3\u5cb8\u8fdb\u884c\u68c0\u67e5\u3002,<\/strong> \u53d6\u4ee3\u4e4b\u524d\u5206\u6563\u7684\u533a\u57df\u6027\u8bc4\u4f30\u3002.<\/p>\n<p>\u901a\u8fc7\u5347\u7ea7 <strong>\u6280\u672f\u5e73\u53f0\uff0c,<\/strong> FDA\u8c03\u67e5\u4eba\u5458\u5728\u505a\u51fa\u51c6\u5165\u51b3\u5b9a\u65f6\u53ef\u4ee5\u66f4\u5feb\u5730\u8bbf\u95ee\u591a\u4e2a\u6570\u636e\u6e90\uff0c\u4ece\u800c\u63d0\u4f9b\u652f\u6301 <strong>\u5b9e\u65f6\u98ce\u9669\u7ba1\u7406\u3002.<\/strong> \u8be5\u7a0b\u5e8f\u80fd\u591f <strong>\u5168\u56fd\u8b66\u62a5<\/strong> \u5bf9\u4e8e\u9ad8\u98ce\u9669\u4ea7\u54c1\uff0c\u5305\u62ec <strong>\u5047\u836f<\/strong> \u548c <strong>\u53d7\u6c61\u67d3\u7684\u98df\u7269,<\/strong> \u5b9e\u73b0\u8de8\u7aef\u53e3\u66f4\u5feb\u3001\u66f4\u4e00\u81f4\u7684\u54cd\u5e94\u3002.<\/p>\n<p>\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\uff08FDA\uff09\u4e5f\u62a5\u544a\u79f0\uff1a <strong>\u6708\u8fdb\u53e3\u5904\u7406\u80fd\u529b\u6709\u6240\u63d0\u9ad8\uff0c,<\/strong> \u867d\u7136<strong> \u8fdb\u53e3\u5ba1\u6838\u6240\u9700\u7684\u4eba\u5de5\u65f6\u6570\u51cf\u5c11\u4e86\u3002,<\/strong> \u53cd\u6620\u51fa\u8fd0\u8425\u6548\u7387\u7684\u63d0\u9ad8\u3002\u91cd\u8981\u7684\u662f\uff0c, <strong>\u6301\u7eed\u7684\u6267\u6cd5\u63aa\u65bd<\/strong> \u73b0\u5728\u5df2\u5e94\u7528\u4e8e\u6240\u6709\u53d7 FDA \u76d1\u7ba1\u7684\u4ea7\u54c1\u7c7b\u522b\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-272212968 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-471634896\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u751f\u6548\u65e5\u671f<\/h2>\n\t<div id=\"gap-694594423\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-694594423 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u66f4\u65b0\u540e\u7684 <strong>FDA ImportShield\u8ba1\u5212\u8981\u6c42<\/strong> \u81ea\u90a3\u65f6\u8d77\uff0c\u8be5\u89c4\u5b9a\u5df2\u9002\u7528\u4e8e\u6240\u6709\u8fdb\u5165\u7f8e\u56fd\u6e2f\u53e3\u7684\u53d7FDA\u76d1\u7ba1\u7684\u8fdb\u53e3\u4ea7\u54c1\u3002 <strong>2025\u5e748\u6708\u3002. <\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-471634896 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-917773794\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e3a\u4ec0\u4e48\u91cd\u8981<\/h2>\n\t<div id=\"gap-692689858\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-692689858 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>ImportShield\u8ba1\u5212\u63d0\u4f9b\u66f4\u5927\u7684 <strong>\u76d1\u7ba1\u7684\u6e05\u6670\u5ea6\u548c\u4e00\u81f4\u6027<\/strong> \u901a\u8fc7\u5168\u56fd\u7edf\u4e00\u7684\u8fdb\u53e3\u5ba1\u67e5\u6807\u51c6\u3002\u589e\u5f3a <strong>\u6570\u5b57\u878d\u5408<\/strong> \u96c6\u4e2d\u7b5b\u67e5\u63d0\u9ad8\u4e86\u6548\u7387\uff0c\u540c\u65f6\u652f\u6301\u4e3b\u52a8\u8bc6\u522b\u9ad8\u98ce\u9669\u8fdb\u53e3\u5546\u54c1\uff0c\u5e2e\u52a9 FDA \u7ba1\u7406\u4e0d\u65ad\u589e\u957f\u7684\u8fdb\u53e3\u91cf\uff0c\u800c\u4e0d\u4f1a\u9020\u6210\u4e0d\u5fc5\u8981\u7684\u884c\u653f\u8d1f\u62c5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-917773794 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-1053723998\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u8fd9\u9002\u7528\u4e8e\u54ea\u4e9b\u4eba\u7fa4<\/h2>\n\t<div id=\"gap-312516902\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-312516902 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u6b64\u66f4\u65b0\u5c24\u5176\u9002\u7528\u4e8e <strong>\u6cd5\u89c4\u4e8b\u52a1\u3001\u8d28\u91cf\u4fdd\u8bc1\u3001\u5408\u89c4\u3001\u4f9b\u5e94\u94fe\u548cIT\u56e2\u961f,<\/strong> \u4ee5\u53ca\u8d1f\u8d23\u5c06\u53d7 FDA \u76d1\u7ba1\u7684\u4ea7\u54c1\u8fdb\u53e3\u5230\u7f8e\u56fd\u5e02\u573a\u7684\u7ec4\u7ec7\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-1053723998 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-884053282\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h2>\u4e0b\u4e00\u6b65<\/h2>\n\t<div id=\"gap-1597052470\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1597052470 {\n  padding-top: 15px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fdb\u53e3\u5546\u5e94\u5ba1\u67e5\u5f53\u524d\u7684\u8fdb\u53e3\u548c\u5355\u8bc1\u7a0b\u5e8f\uff0c\u4ee5\u786e\u4fdd\u5176\u7b26\u5408\u76f8\u5173\u89c4\u5b9a\u3002 <strong>FDA\u96c6\u4e2d\u5ba1\u67e5\u6d41\u7a0b\u3002.<\/strong> \u8de8\u804c\u80fd\u56e2\u961f\u5e94\u8bc4\u4f30\u51c6\u5907\u60c5\u51b5 <strong>\u5b9e\u65f6\u6570\u636e\u8bf7\u6c42,<\/strong> \u52a0\u5f3a <strong>\u53ef\u8ffd\u6eaf\u6027\u5b9e\u8df5\uff0c,<\/strong> \u5e76\u66f4\u65b0\u5185\u90e8\u57f9\u8bad\uff0c\u4ee5\u53cd\u6620\u65b0\u7684\u8fdb\u53e3\u76d1\u7ba1\u6846\u67b6\u3002.<\/p>\n<p>\u968f\u7740\u8fdb\u53e3\u76d1\u7ba1\u65e5\u76ca\u96c6\u4e2d\u5316\u548c\u6570\u636e\u9a71\u52a8\u5316\uff0c\u5404\u7ec4\u7ec7\u9700\u8981\u53ca\u65f6\u4e86\u89e3\u8de8\u5883\u76d1\u7ba1\u9884\u671f\u3002. <strong>RegASK \u662f\u9886\u5148\u7684\u667a\u80fd\u4f53\u4eba\u5de5\u667a\u80fd\u76d1\u7ba1\u667a\u80fd\u548c\u5de5\u4f5c\u6d41\u7a0b\u7f16\u6392\u5e73\u53f0<\/strong> \u8be5\u5e73\u53f0\u8d4b\u80fd\u5168\u7403\u9ad8\u5ea6\u76d1\u7ba1\u884c\u4e1a\u7684\u4f01\u4e1a\uff0c\u5305\u62ec\u6d88\u8d39\u54c1\u548c\u751f\u547d\u79d1\u5b66\u9886\u57df\uff0c\u4f7f\u5176\u80fd\u591f\u4e3b\u52a8\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002\u901a\u8fc7\u7ed3\u5408\u5148\u8fdb\u7684\u6280\u672f\uff0c\u8be5\u5e73\u53f0\u80fd\u591f\u5e2e\u52a9\u4f01\u4e1a\u5e94\u5bf9\u590d\u6742\u7684\u76d1\u7ba1\u73af\u5883\u3002 <strong>\u4ee3\u7406\u4eba\u5de5\u667a\u80fd<\/strong> RegASK \u4e0e\u4e13\u5bb6\u5408\u4f5c\uff0c\u63d0\u4f9b\u53ca\u65f6\u3001\u53ef\u9884\u6d4b\u3001\u53ef\u64cd\u4f5c\u7684\u89c1\u89e3\u548c\u7aef\u5230\u7aef\u7684\u81ea\u52a8\u5316\uff0c\u5e2e\u52a9\u56e2\u961f\u4e0e\u4e0d\u65ad\u53d8\u5316\u7684 FDA \u8fdb\u53e3\u7ba1\u5236\u4fdd\u6301\u4e00\u81f4\uff0c\u540c\u65f6\u964d\u4f4e\u5408\u89c4\u98ce\u9669\u3002. <a href=\"https:\/\/regask.com\/zh\/\"><strong>\u4e86\u89e3\u66f4\u591a<\/strong><\/a> \u6216\u8005 <a href=\"https:\/\/regask.com\/zh\/%e9%a2%84%e8%ae%a2%e6%bc%94%e7%a4%ba\/\"><strong>\u7acb\u5373\u9884\u8ba2\u6f14\u793a\u3002\u00a0<\/strong><\/a><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-884053282 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n<\/div>\n<div class=\"row\"  id=\"row-1314301167\">\n\n\t<div id=\"col-293894082\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<div class=\"is-divider divider clearfix\" style=\"margin-top:2em;margin-bottom:2em;max-width:20%;height:1px;background-color:#a5acd9;\"><\/div>\n<h3>\u5e38\u89c1\u95ee\u9898\u89e3\u7b54<\/h3>\n\t<div id=\"gap-1205427147\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1205427147 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<h4>FDA ImportShield\u8ba1\u5212\u662f\u4ec0\u4e48\uff1f<\/h4>\n\t<div id=\"gap-2081978790\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2081978790 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8fd9 <strong>FDA ImportShield Program (FISP)<\/strong> \u662f\u7531\u7f8e\u56fd\u98df\u54c1\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40 (FDA) \u53d1\u8d77\u7684\u4e00\u9879\u96c6\u4e2d\u5f0f\u56fd\u5bb6\u6846\u67b6\uff0c\u65e8\u5728\u5bf9\u7f8e\u56fd\u5165\u5883\u53e3\u5cb8\u8fdb\u53e3\u7684\u53d7 FDA \u76d1\u7ba1\u7684\u4ea7\u54c1\u8fdb\u884c\u73b0\u4ee3\u5316\u548c\u52a0\u5f3a\u5ba1\u67e5\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-293894082 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-778701730\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>FDA ImportShield\u8ba1\u5212\u4f55\u65f6\u751f\u6548\uff1f<\/h4>\n\t<div id=\"gap-1313962387\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1313962387 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u8ba1\u5212\u4e8e <strong>2025\u5e748\u6708,<\/strong> \u521d\u6b65\u7ed3\u679c\u5df2\u4e8e <strong>2026\u5e741\u670821\u65e5\u3002.<\/strong><\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-778701730 > .col-inner {\n  margin: 0px 0px -20px 0px;\n}\n<\/style>\n\t<\/div>\n\n\t\n\n\t<div id=\"col-336316396\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<h4>ImportShield\u6db5\u76d6\u54ea\u4e9b\u4ea7\u54c1\uff1f<\/h4>\n\t<div id=\"gap-1987279288\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1987279288 {\n  padding-top: 10px;\n}\n<\/style>\n\t<\/div>\n\t\n<p>\u8be5\u6cd5\u89c4\u5f71\u54cd <strong>\u98df\u54c1\u3001\u836f\u54c1\u548c\u533b\u7597\u5668\u68b0\u884c\u4e1a\u7684\u8fdb\u53e3\u5546,<\/strong> \u7279\u522b\u662f\u90a3\u4e9b\u7ecf\u8425\u7279\u5b9a\u9650\u5236\u5546\u54c1\u7684\u3002.<\/p>\n\t\t<\/div>\n\t\t\t\t\n<style>\n#col-336316396 > .col-inner {\n 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