{"id":42719,"date":"2020-03-06T16:39:59","date_gmt":"2020-03-06T16:39:59","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand\/"},"modified":"2020-03-26T16:57:50","modified_gmt":"2020-03-26T16:57:50","slug":"us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/us-buyers-seek-surgical-mask-suppliers-here-are-the-regulatory-requirements-for-helping-to-meet-the-demand\/","title":{"rendered":"\u7f8e\u56fd\u4e70\u5bb6\u5bfb\u6c42\u533b\u7528\u53e3\u7f69\u4f9b\u5e94\u5546: \u51fa\u53e3\u4e4b\u524d\u60a8\u9700\u8981\u4e86\u89e3\u7684\u6cd5\u89c4\u8981\u6c42"},"content":{"rendered":"<p>\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u5df2\u7ecf\u5f00\u59cb\u5728\u7f8e\u56fd\u6269\u6563\uff0c\u7531\u6b64\u4e5f\u5bfc\u81f4\u5168\u56fd\u8303\u56f4\u7684\u53e3\u7f69\u77ed\u7f3a\u3002\u968f\u7740\u75ab\u60c5\u7684\u6301\u7eed\u6f2b\u5ef6\uff0cRegistrar Corp\u4e5f\u6536\u5230\u8d8a\u6765\u8d8a\u591a\u5168\u7403\u5404\u5730\u751f\u4ea7\u5546\u5173\u4e8eFDA\u5bf9\u53e3\u7f69\u53ca\u5176\u4ed6\u6297\u75ab\u7269\u8d44\u6cd5\u89c4\u8981\u6c42\u7684\u54a8\u8be2\u3002<\/p>\n<p>\u5c3d\u7ba1\u536b\u751f\u90e8\u90e8\u957f\u544a\u77e5\u6c11\u4f17\u4e0d\u5fc5\u8d2d\u4e70\u53e3\u7f69\uff0c\u4f46\u662f\u96f6\u552e\u5546\u5374\u53d1\u73b0\u5e02\u573a\u4e0a\u6709\u5927\u91cf\u7684\u53e3\u7f69\u9700\u6c42\u3002\u636e<a href=\"https:\/\/edition.cnn.com\/2020\/02\/29\/health\/face-masks-coronavirus-surgeon-general-trnd\/index.html\">CNN\u5468\u4e00\u7684\u62a5\u9053<\/a>\uff0c\u201c\u5168\u56fd\u6240\u6709\u5546\u5e97\u7684\u53e3\u7f69\u90fd\u5356\u5149\u4e86\u3002\u201d \u6839\u636e\u6211\u4eec\u63a5\u5230\u7684\u6765\u7535\u54a8\u8be2\uff0c\u7f8e\u56fd\u7c89\u7b14\u7684\u4e70\u5bb6\u4f3c\u4e4e\u6b63\u5728\u5bfb\u6c42\u65b0\u7684\u4f9b\u5e94\u5546\uff0c\u4ee5\u8865\u5145\u73b0\u6709\u7684\u8ba2\u5355\u5e76\u6ee1\u8db3\u4e0d\u65ad\u589e\u957f\u7684\u9700\u6c42\u3002<\/p>\n<p><strong>FDA<\/strong><strong>\u5bf9\u53e3\u7f69\u7684\u8981\u6c42<\/strong><\/p>\n<p>\u5411\u7f8e\u56fd\u51fa\u53e3\u53e3\u7f69\u7684\u7b2c\u4e00\u6b65\u5c31\u662f\u786e\u5b9a\u8d35\u53f8\u7684\u4ea7\u54c1\u4ee3\u7801\uff0c\u56e0\u4e3a\u8fd9\u662f\u786e\u5b9a\u8d35\u53f8\u7684\u4ea7\u54c1\u662f\u5426\u9700\u8981\u5411FDA\u9012\u4ea4510k\u7533\u8bf7\u6216\u8005NIOSH\u7684\u51b3\u5b9a\u6027\u56e0\u7d20\u3002<\/p>\n<p><em>\u9700\u8981<\/em><em>510k<\/em><em>\u7684\u4ea7\u54c1\u4ee3\u7801<\/em><\/p>\n<p>\u58f0\u79f0\u53ef\u4ee5\u9884\u9632\u611f\u67d3\u6216\u5177\u6709\u6297\u75c5\u6bd2\u6216\u6297\u83cc\u7279\u6027\u7684\u53e3\u7f69\u6216\u9762\u7f69\u88ab\u8ba4\u5b9a\u4e3a\u4e8c\u7c7b\u533b\u7597\u5668\u68b0\uff0c\u9700\u8981\u901a\u8fc7FDA\u7684\u4e0a\u5e02\u524d\u901a\u77e5(510k)\u3002\u8fd9\u79cd\u7c7b\u578b\u7684\u4ea7\u54c1\u4ee3\u7801\u6709<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2846\">FXX<\/a>, <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2874\">OUK<\/a>, or <a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2757\">ORW<\/a>\u3002ORW\u8fd9\u4e2a\u4ea7\u54c1\u4ee3\u7801\u5bf9\u5e94\u7684\u4ea7\u54c1\u662fN95\u53e3\u7f69\u3002\u6240\u6709\u9700\u8981\u7528ORW\u8fdb\u884c\u5217\u540d\u7684\u53e3\u7f69\u5fc5\u987b\u901a\u8fc7NIOSH\u8ba4\u8bc1\uff0c\u4ee5\u8fc7\u6ee4\u81f3\u5c1195%\u7684\u7a7a\u6c14\u9897\u7c92\u7269\u3002\uff09<\/p>\n<p><em>\u4e0d\u9700\u8981<\/em><em>510k<\/em><em>\u7684\u4ea7\u54c1\u4ee3\u7801<\/em><\/p>\n<p>\u4e0d\u58f0\u79f0\u53ef\u4ee5\u9884\u9632\u611f\u67d3\u6216\u5177\u6709\u6297\u75c5\u6bd2\u6216\u6297\u83cc\u7279\u6027\u7684\u53e3\u7f69\u4e0d\u9700\u8981\u901a\u8fc7FDA\u7684\u4e0a\u5e02\u524d\u901a\u77e5(510k)\u3002\u4f8b\u5982\uff0c\u53ea\u8981\u4e0d\u58f0\u79f0\u53ef\u4ee5\u9884\u9632\u611f\u67d3\u6216\u5177\u6709\u6297\u75c5\u6bd2\u6216\u6297\u83cc\u7279\u6027\uff0c\u5e76\u4e14\u8bc1\u660e\u53ef\u4ee5\u6709\u6548\u963b\u6321\u6db2\u4f53\uff08\u6bd4\u5982\u8840\u6db2\u548c\u4f53\u6db2\uff09\u7a7f\u900f\u7684\u5916\u79d1\u53e3\u7f69\u53ef\u4ee5\u4e0d\u9700\u8981510k\u7528<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2864\">MSH<\/a>\u8fdb\u884c\u5217\u540d\u3002\u9700\u8981\u6ce8\u610f\u7684\u662fMSH\u8fd9\u4e2a\u4ea7\u54c1\u4ee3\u7801\u4e5f\u9002\u7528\u4e8eN95\u53e3\u7f69\u3002\u56e0\u6b64\uff0c\u5c3d\u7ba1\u7528\u8fd9\u4e2a\u4ee3\u7801\u505a\u5217\u540d\u7684\u53e3\u7f69\u4e0d\u9700\u8981510k,\u4f46\u662f\u4ecd\u7136\u9700\u8981\u901a\u8fc7NIOSH\u8ba4\u8bc1\u3002<\/p>\n<p>\u751f\u4ea7\u4e0d\u9700\u8981510k\u7684\u53e3\u7f69\u7684\u4f01\u4e1a\u53ea\u9700\u8981<a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">\u5411FDA\u8fdb\u884c\u4f01\u4e1a\u6ce8\u518c<\/a>\u5e76\u8fdb\u884c\u4ea7\u54c1\u5217\u540d\u5373\u53ef\u3002<\/p>\n<p><strong>\u5982\u4f55\u83b7\u5f97<\/strong><strong>510k<\/strong><\/p>\n<p>\u751f\u4ea7\u5546\u5411FDA\u9012\u4ea4\u4e0a\u5e02\u524d\u7533\u8bf7(\u4e5f\u79f0\u4e3a510k)\u540eFDA\u4f1a\u51fa\u5177\u6279\u51c6\u51fd\u3002510(k)\u662f\u4e3a\u4e86\u5411FDA\u8bc1\u660e\u4e00\u79cd\u4ea7\u54c1\u4e0e\u5e02\u573a\u4e0a\u5df2\u6709\u7684\u540c\u7c7b\u4ea7\u54c1\u5728\u672c\u8d28\u4e0a\u662f\u76f8\u540c\u7684(\u540c\u6837\u7684\u9884\u671f\u7528\u9014\uff0c\u540c\u6837\u5b89\u5168\u6709\u6548)\u3002<\/p>\n<p>\u9664\u4e86\u5176\u4ed6\u65b9\u9762\uff0c\u4e0a\u5e02\u524d\u901a\u77e5\u5fc5\u987b\u8981\u5305\u542b\u4ea7\u54c1\u7c7b\u522b\u548c\u8bbe\u8ba1\u597d\u7684\u6807\u7b7e\u3002<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=807&amp;showFR=1&amp;subpartNode=21:8.0.1.1.5.5\">21 CFR 807<\/a> \u6982\u8ff0\u4e86510(k)\u7533\u8bf7\u7684\u5168\u90e8\u8981\u6c42\u3002\u4e00\u65e6\u83b7\u5f97\u4e86FDA\u7684 510(k)\u6279\u51c6\u51fd\uff0c\u8d35\u53f8\u5fc5\u987b\u8981\u5728\u51fa\u53e3\u4ea7\u54c1\u4e4b\u524d<a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">\u5411FDA\u8fdb\u884c\u4f01\u4e1a\u6ce8\u518c\u548c\u4ea7\u54c1\u5217\u540d<\/a>\u3002<\/p>\n<p>\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u7531\u4e8e\u65b0\u51a0\u75ab\u60c5\uff0cFDA\u5df2\u7ecf\u5efa\u7acb\u4e86\u9488\u5bf9\u51a0\u72b6\u75c5\u6bd2\u7684<a href=\"https:\/\/www.fda.gov\/medical-devices\/emergency-situations-medical-devices\/emergency-use-authorizations#coronavirus2019\">\u7d27\u6025\u4f7f\u7528\u6388\u6743<\/a>\uff0c\u5e76\u6b63\u5728\u5bf9\u67d0\u4e9b\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u4ea7\u54c1\u6267\u884c\u81ea\u7531\u88c1\u91cf\u6743\u3002\u4e3a\u5e94\u5bf9\u75ab\u60c5\uff0cFDA\u5df2\u8868\u793a\u5b83\u53ef\u80fd\u4f1a\u8003\u8651\u52a0\u5feb\u5ba1\u67e5\u751f\u4ea7\u5730\u5740\u7684\u53d8\u66f4\u6216\u4e0a\u5e02\u524d\u7533\u62a5\uff0c\u4ee5\u5e2e\u52a9\u7f13\u89e3\u4f9b\u5e94\u538b\u529b\u3002<\/p>\n<p><strong>\u5176\u4ed6\u9632\u611f\u67d3\u533b\u7597\u5668\u68b0<\/strong><\/p>\n<p>\u7528\u4e8e\u9632\u6b62\u533b\u751f\u548c\u75c5\u4eba\u4ea4\u53c9\u611f\u67d3\u7684\u533b\u7528\u624b\u5957\u548c\u547c\u5438\u673a\u9700\u8981510(k)\u3002\u4f46\u5e76\u975e\u6240\u6709\u9700\u6c42\u91cf\u5927\u7684\u9632\u611f\u67d3\u5668\u68b0\u90fd\u9700\u8981\u5982\u6b64\u4e25\u683c\u7684\u5ba1\u67e5\u3002<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfpcd\/classification.cfm?id=5364\">\u9632\u62a4\u773c\u955c<\/a>\u548c<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2843\">\u9632\u62a4\u670d<\/a>\uff08\u4e0d\u8981\u4e0e<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfPCD\/classification.cfm?id=2848\">\u624b\u672f\u670d<\/a>\u6df7\u6dc6\u4e86\uff0c\u624b\u672f\u670d\u5c5e\u4e8e\u4e8c\u7c7b\u7684\u533b\u7597\u5668\u68b0\uff09\u90fd\u662f\u4e00\u7c7b\u7684\u533b\u7597\u5668\u68b0\uff0c\u4e0d\u9700\u8981 510(k)\u3002\u8c41\u514d\u4e8e 510(k)\u7684\u751f\u4ea7\u5546\u4ecd\u7136\u9700\u8981<a href=\"https:\/\/regstaging.wpengine.com\/fda-medical-devices\/registration\/?lead_source=blog\">\u5411FDA\u8fdb\u884c\u4f01\u4e1a\u6ce8\u518c<\/a>\u548c\u4ea7\u54c1\u5217\u540d\u3002<\/p>\n<p>FDA\u54a8\u8be2\u673a\u6784\uff0cRegistrar Corp\u53ef\u4ee5\u534f\u52a9\u751f\u4ea7\u5546\u5224\u65ad\u5176\u4ea7\u54c1\u5bf9\u5e94\u7684\u4ea7\u54c1\u4ee3\u7801\u4ee5\u53ca\u76f8\u5173\u7684FDA\u6cd5\u89c4\u8981\u6c42\u3002\u60a8\u53ef\u4ee5\u901a\u8fc7\u53d1\u9001\u7535\u5b50\u90ae\u4ef6\u81f3<a href=\"mailto:info@registrarcorp.com\">info@registrarcorp.com<\/a> \uff0c\u6216\u8005\u81f4\u7535\u6211\u4eec\u5168\u7403\u7684<a href=\"https:\/\/regstaging.wpengine.com\/offices\/\">20\u4e2a\u4ee3\u8868\u5904<\/a>\u4e0e\u6211\u4eec\u8054\u7cfb\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u65b0\u578b\u51a0\u72b6\u75c5\u6bd2\u5df2\u7ecf\u5f00\u59cb\u5728\u7f8e\u56fd\u6269\u6563\uff0c\u7531\u6b64\u4e5f\u5bfc\u81f4\u5168\u56fd\u8303\u56f4\u7684\u53e3\u7f69\u77ed\u7f3a\u3002\u968f\u7740\u75ab\u60c5\u7684\u6301\u7eed\u6f2b\u5ef6\uff0cRegistrar Corp\u4e5f\u6536\u5230\u8d8a\u6765\u8d8a\u591a\u5168\u7403\u5404\u5730\u751f\u4ea7\u5546\u5173\u4e8eFDA\u5bf9\u53e3\u7f69\u53ca\u5176\u4ed6\u6297\u75ab\u7269\u8d44\u6cd5\u89c4\u8981\u6c42\u7684\u54a8\u8be2\u3002 \u5c3d\u7ba1\u536b\u751f\u90e8\u90e8\u957f\u544a\u77e5\u6c11\u4f17\u4e0d\u5fc5\u8d2d\u4e70\u53e3\u7f69\uff0c\u4f46\u662f\u96f6\u552e\u5546\u5374\u53d1\u73b0\u5e02\u573a\u4e0a\u6709\u5927\u91cf\u7684\u53e3\u7f69\u9700\u6c42\u3002\u636eCNN\u5468\u4e00\u7684\u62a5\u9053\uff0c\u201c\u5168\u56fd\u6240\u6709\u5546\u5e97\u7684\u53e3\u7f69\u90fd\u5356\u5149\u4e86\u3002\u201d \u6839\u636e\u6211\u4eec\u63a5\u5230\u7684\u6765\u7535\u54a8\u8be2\uff0c\u7f8e\u56fd\u7c89\u7b14\u7684\u4e70\u5bb6\u4f3c\u4e4e\u6b63\u5728\u5bfb\u6c42\u65b0\u7684\u4f9b\u5e94\u5546\uff0c\u4ee5\u8865\u5145\u73b0\u6709\u7684\u8ba2\u5355\u5e76\u6ee1\u8db3\u4e0d\u65ad\u589e\u957f\u7684\u9700\u6c42\u3002 FDA\u5bf9\u53e3\u7f69\u7684\u8981\u6c42 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