{"id":7224,"date":"2023-02-01T16:22:33","date_gmt":"2023-02-01T08:22:33","guid":{"rendered":"https:\/\/business.medtecs.com\/usa-ppe-exporting-and-importing-procedures\/"},"modified":"2023-06-29T10:43:36","modified_gmt":"2023-06-29T02:43:36","slug":"usa-ppe-exporting-and-importing-procedures","status":"publish","type":"post","link":"https:\/\/01.business-medtecs.rcdmkt.com\/zh-hant\/usa-ppe-exporting-and-importing-procedures\/","title":{"rendered":"\u9632\u8b77\u8863&#038;\u9694\u96e2\u8863\u7b49\u500b\u4eba\u9632\u8b77\u8a2d\u5099(PPE)\u9032\u51fa\u53e3\u81f3\u7f8e\u570b\u6d41\u7a0b"},"content":{"rendered":"<blockquote><p>FDA\u57282020\u5e743\u6708\u5ba3\u5e03\uff0c\u7531\u65bcCovid-19\u5927\u6d41\u884c\u60c5\u6cc1\u548c\u91ab\u7642\u7528\u54c1\u77ed\u7f3a\uff0c<strong>FDA\u7f8e\u570b\u5c07\u514d\u9664PPE\u7684\u4e0a\u5e02\u524d\u5be9\u67e5\u8981\u6c42\u3002<\/strong><\/p><\/blockquote>\n<h2>\u9032\u51fa\u53e3\u500b\u4eba\u9632\u8b77\u8a2d\u5099\u81f3\u7f8e\u570b\u7684\u6d41\u7a0b\u6709\u54ea\u4e9b\uff1f<\/h2>\n<p>COVID-19\u5927\u6d41\u884c\u63a8\u52d5\u4e86\u91ab\u7642\u4fdd\u5065\u5c08\u696d\u4eba\u54e1\u548c\u516c\u773e\u5c0d\u500b\u4eba\u9632\u8b77\u8a2d\u5099\uff08PPE\uff09\u7684\u9700\u6c42\u3002\u5c0d\u65bc\u9032\u51fa\u53e3\u5546\u4f86\u8aaa\uff0c\u70ba\u4e86\u907f\u514d\u8207PPE\u9032\u53e3\u76f8\u95dc\u7684\u6311\u6230\u548c\u98a8\u96aa\uff0c\u9700\u8981\u4e86\u89e3\u4e00\u4e9b\u91cd\u8981\u7684\u7d30\u7bc0\u3002<\/p>\n<p>&nbsp;<\/p>\n<h2>\u6b63\u5e38\u7533\u8acb\u7a0b\u5e8f &#8211; 21CFR Subpart E<\/h2>\n<p><a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-807\/subpart-E\" target=\"_blank\" rel=\"noopener\">21 CFR 807 Subpart E<\/a>\u63cf\u8ff0\u4e86510\uff08k\uff09\u63d0\u4ea4\u7684\u8981\u6c42\u3002\u5728\u92b7\u552e\u8a2d\u5099\u4e4b\u524d\uff0c\u6bcf\u500b\u63d0\u4ea4\u8005\u90fd\u5fc5\u9808\u5f9eFDA\u6536\u5230\u4e00\u5c01\u4fe1\u51fd\u5f62\u5f0f\u7684\u8a02\u55ae\uff0c\u8a72\u547d\u4ee4\u8a8d\u70ba\u8a72\u8a2d\u5099\u5be6\u8cea\u4e0a\u662f\u7b49\u6548\u7684\uff08SE\uff09\uff0c\u4e26\u8072\u660e\u8a72\u8a2d\u5099\u53ef\u4ee5\u5728\u7f8e\u570b\u92b7\u552e\u3002<\/p>\n<p>510\uff08k\uff09\u662f\u5411FDA\u63d0\u4ea4\u7684\u4e0a\u5e02\u524d\u8072\u660e\uff0c\u4ee5\u8b49\u660e\u6240\u92b7\u552e\u7684\u8a2d\u5099\u81f3\u5c11\u8207\u5408\u6cd5\u92b7\u552e\u7684\u8a2d\u5099\u4e00\u6a23\u5b89\u5168\u6709\u6548\uff0c\u5373\u8207\u5408\u6cd5\u92b7\u552e\u7684\u8a2d\u5099\u57fa\u672c\u76f8\u540c\uff0821 CFR 807.92\uff08a\uff09\uff083\uff09\uff09\u3002\u4e0d\u53d7PMA\u7d04\u675f\u3002\u63d0\u4ea4\u8005\u5fc5\u9808\u5c07\u5176\u8a2d\u5099\u8207\u4e00\u500b\u6216\u591a\u500b\u5408\u6cd5\u92b7\u552e\u7684\u8a2d\u5099\u9032\u884c\u6bd4\u8f03\uff0c\u4e26\u63d0\u51fa\u4e26\u652f\u6301\u5176\u5be6\u8cea\u7b49\u6548\u8072\u660e\u3002<\/p>\n<blockquote><p>\u6280\u8853\u6587\u4ef6: <a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/21\/part-807\/subpart-E\" target=\"_blank\" rel=\"noopener\">21 CFR Subpart E<\/a><\/p><\/blockquote>\n<h2>\u7533\u8acb\u6642\u9593\u6d41\u7a0b<\/h2>\n<ul>\n<li>FDA\u627f\u8afe\u5728\u63d0\u4ea4\u7533\u8acb\u5f8c\u7684<strong>90\u5929\u5167<\/strong>\u5411\u88fd\u9020\u5546\u63d0\u4f9b\u56de\u8986\u3002\n<ol>\n<li>FDA\u5c07\u5728<strong>7\u5929\u5167<\/strong>\u505a\u51fa\u56de\u61c9\uff0c\u544a\u77e5\u60a8\u662f\u5426\u5df2\u6536\u5230\u8a72\u7533\u8acb\u3002<\/li>\n<li>FDA\u5c07\u5728<strong>15\u5929\u5167<\/strong>\u56de\u8986\u60a8\uff0c\u544a\u77e5\u60a8\u6240\u6709\u6587\u4ef6\u662f\u5426\u9f4a\u5168\u3002<\/li>\n<li>\u5982\u679c\u4fe1\u606f\u4e0d\u5b8c\u6574\uff0c\u60a8\u5c07\u6709<strong>180\u5929\u7684<\/strong>\u6642\u9593\u5b8c\u6210\u8981\u6c42\u3002<\/li>\n<li>\u5b8c\u6210\u6240\u6709\u6587\u6a94\u5f8c\uff0c\u5c07\u5728<strong>90\u5929\u5167<\/strong>\u63d0\u4f9b\u6700\u7d42\u7d50\u679c<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<h2>\u00a0\u8981\u6c42\u63d0\u4f9b\u4e4b\u8cc7\u8a0a<\/h2>\n<ol>\n<li>\u8981\u6c42\uff08\u63d0\u4f9b\uff09\u7684\u4fe1\u606f\uff1a\n<ul>\n<li>\u5ee0\u5546\u540d\u7a31<\/li>\n<li>\u7522\u54c1\u540d\u7a31\u548c\u8aaa\u660e<\/li>\n<li>\u7522\u54c1\u5206\u985e\u8aaa\u660e\uff0c\u4f8b\u5982\u624b\u8853\u8863\u6216\u5de5\u4f5c\u670d\u3002<\/li>\n<li>\u7522\u54c1\u5206\u985e\u865f<\/li>\n<li>\u5982\u679c\u9700\u8981\uff0c\u63d0\u4f9b\u63cf\u8ff0\u76f8\u4f3c\u7522\u54c1\u7684\u6587\u672c\uff0c\u5305\u62ec\u76f8\u4f3c\u7522\u54c1\u7684\u540d\u7a31\uff0c\u7522\u54c1\u540d\u7a31\u548c\u63cf\u8ff0<\/li>\n<li>\u7f8e\u570b\u806f\u7e6b\u4eba\u7684\u806f\u7e6b\u4fe1\u606f\u3002<\/li>\n<\/ul>\n<\/li>\n<li>\u00a0\u78ba\u8a8d\u7522\u54c1\u7b26\u5408<a href=\"https:\/\/wwwn.cdc.gov\/PPEInfo\/Standards\/Info\/ANSI\/AAMIPB70Class3\" target=\"_blank\" rel=\"noopener\">ANSI \/ AAMI PB 70<\/a>\u6a19\u6e96\u7684\u9632\u8b77\u670d\u98a8\u96aa\u7b49\u7d1a\u7684\u6587\u6a94\u3002<\/li>\n<li>\u4e00\u4efd\u8868\u660e\u8a72\u7522\u54c1\u7b26\u5408<a href=\"https:\/\/wwwn.cdc.gov\/PPEInfo\/Standards\/Info\/ANSI\/AAMIPB70Class3\" target=\"_blank\" rel=\"noopener\">ANSI \/ AAMI PB70<\/a>\u9632\u8b77\u670d\u6a19\u6e96\u7684\u6e2c\u8a66\u5831\u544a\u3002<\/li>\n<li>\u60a8\u9700\u8981\u63d0\u4f9b\u7522\u54c1\u8349\u5716\uff0c\u7167\u7247\u4ee5\u5354\u52a9\u7522\u54c1\u4f48\u5c40\u3002\u61c9\u6a19\u660e\u7522\u54c1\u7684\u9632\u8b77\u7b49\u7d1a\u3002<\/li>\n<li>\u60a8\u9084\u9700\u8981\u986f\u793a<strong>\u7522\u54c1\u7684\u95dc\u9375\u5340\u57df<\/strong>\uff0c\u4ee5\u53ca<strong>\u95dc\u9375\u5340\u57df<\/strong>\u7684<strong>\u4fdd\u8b77\u529f\u7387<\/strong>\u548c<strong>\u7e2b\u7d09\u65b9\u6cd5<\/strong>\u3002<\/li>\n<li>\u660e\u78ba\u6307\u51fa\u7522\u54c1\u7b26\u5408<strong>ANSI \/ AAMI PB70\u6a19\u6e96<\/strong>\u7684\u4fdd\u8b77\u7b49\u7d1a<\/li>\n<li>\u9700\u8981\u6a23\u672c\u6a19\u7c64\u4ee5\u6e05\u695a\u5730\u6307\u793a\u5982\u4f55\u4f7f\u7528\u7522\u54c1\u4ee5\u53ca\u5efa\u8b70\u7684\u4f7f\u7528\u5834\u5408\u3002<\/li>\n<li>\u5176\u4ed6\u6307\u793a\u5167\u5bb9\uff0c\u5c3a\u5bf8\uff0c\u6578\u91cf\uff0c\u88fd\u9020\u5546\u540d\u7a31\uff0c\u88fd\u9020\u6279\u865f\u7684\u6a19\u7c64\uff0c\u4ee5\u53ca\u5176\u4ed6\u6307\u793a\u7522\u54c1\u5167\u5bb9\uff0c\u5c3a\u5bf8\uff0c\u6578\u91cf\uff0c\u88fd\u9020\u5546\u540d\u7a31\uff0c\u88fd\u9020\u6279\u865f\u548c\u4efb\u4f55\u8b66\u544a\u6d88\u606f\u7684\u6a19\u7c64\u6a23\u672c\u3002<\/li>\n<li>\u6a23\u54c1\u6a19\u7c64\u8b49\u660e\u8a72\u7522\u54c1\u7b26\u5408\u751f\u7269\u76f8\u5bb9\u6027\u548c\u76ae\u819a\u63a5\u89f8\u6a19\u6e96\uff08<strong>ISO 109935<\/strong>\u548c<strong>ISO 1099310<\/strong>\u7b49\uff09\u3002<\/li>\n<li>\u6709\u95dc\u7522\u54c1\u6ec5\u83cc\u7684\u4fe1\u606f\uff0c\u5305\u62ec\u6ec5\u83cc\u65b9\u6cd5\uff0c\u6ec5\u83cc\u5b8c\u6210\u9a57\u8b49\u548c\u7121\u83cc\u5305\u88dd\u3002<\/li>\n<li>\u00a0\u6709\u95dc\u63cf\u8ff0\u6b63\u5728\u7533\u8acb\u7684\u7522\u54c1\u548c\u5df2\u6279\u51c6\u7684\u7522\u54c1\u4e4b\u9593\u7684\u9ad8\u5ea6\u76f8\u4f3c\u6027\u7684\u4fe1\u606f\u3002<\/li>\n<\/ol>\n<ol>\n<li style=\"list-style-type: none;\"><\/li>\n<\/ol>\n<h2>\u00a0\u8cbb\u7528\u8207\u6210\u672c<\/h2>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li>\u00a0\u6a19\u6e96\u7533\u8acb\u8cbb\u7528\u70ba11,594\u7f8e\u5143\uff1b\u5c0f\u578b\u4f01\u696d$ 2,899\u7f8e\u5143\u3002\uff08\u5c0f\u578b\u4f01\u696d\u7684\u5b9a\u7fa9\u662f\u4e0a\u4e00\u7d0d\u7a05\u5e74\u5ea6\u7684\u71df\u696d\u984d\u4f4e\u65bc1\u5104\u7f8e\u5143\u7684\u4f01\u696d;\u5982\u679c\u8a72\u4f01\u696d\u7684\u4e0a\u4e00\u7d0d\u7a05\u5e74\u5ea6\u7684\u71df\u696d\u984d\u5c11\u65bc3,000\u842c\u7f8e\u5143\uff0c\u5247\u514d\u9664\u521d\u6b21\u4e0a\u5e02\u524d\u5be9\u67e5\u7684\u8cbb\u7528\uff09<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<h2>2019\u5e74\u51a0\u72c0\u75c5\u6bd2\u75c5\uff08COVID-19\uff09\u91ab\u7642\u8a2d\u5099\u7dca\u6025\u4f7f\u7528\u6388\u6b0a<\/h2>\n<p>FDA\u5df2\u7d93\u63a1\u53d6\u4e86\u5404\u7a2e\u63aa\u65bd\u4f86\u9810\u9632\u548c\u6e1b\u8f15\u95dc\u9375PPE\u7684\u77ed\u7f3a\u3002FDA\u4e0d\u80fd\u5f37\u8feb\u516c\u53f8\u88fd\u9020PPE\uff0c\u5118\u7ba1\u8a72\u6a5f\u69cb\u53ef\u4ee5\u52a0\u5feb\u5be9\u67e5\u901f\u5ea6\uff0c\u5141\u8a31\u4f7f\u7528\u672a\u7d93\u6279\u51c6\u7684\u8a2d\u5099\uff0c\u4e26\u884c\u4f7f\u76e3\u7ba1\u9748\u6d3b\u6027\u4ee5\u6e1b\u5c11\u9032\u5165\u5e02\u5834\u7684\u969c\u7919\u3002<\/p>\n<p>\u901a\u904e\u7dca\u6025\u4f7f\u7528\u6388\u6b0a\uff08EUA\uff09\uff0cFDA\u53ef\u4ee5\u8a2a\u554f\u5c1a\u672a\u7372\u5f97\u6a5f\u69cb\u8a31\u53ef\u7684PPE\uff0821 USC\u00a7360bbb-3\uff09\u3002\u7c21\u800c\u8a00\u4e4b\uff0c\u5982\u679c\u60a8\u5728\u6b64\u671f\u9593\u662fPPE\u7684\u9032\u53e3\u5546\uff0c\u5247\u53ef\u4ee5\u7bc0\u7701\u5f88\u591a\u6587\u66f8\u5de5\u4f5c\u4e0a\u7684\u9ebb\u7169\uff01<\/p>\n<blockquote><p>FDA\u9084\u767c\u5e03\u4e86\u5098\u5f0fEUAs\uff0c\u6db5\u84cb\u4e86\u7b26\u5408\u67d0\u4e9b\u6027\u80fd\u6a19\u6e96\u7684\u5916\u79d1\u53e3\u7f69\u3001\u9762\u7f69\u548c\u5176\u4ed6\u9632\u8b77\u8a2d\u5099\u3002<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<p>\u7531\u65bcFDA\u4fee\u6539\u3001\u64a4\u92b7\u4e26\u6388\u4e88\u4e86\u8a72\u6a5f\u69cb\u8a8d\u70ba\u9069\u7576\u7684\u65b0EUA\uff0c\u56e0\u6b64\u672c\u201c\u91cd\u9ede\u95dc\u6ce8\u201d\u4e26\u4e0d\u662f\u6240\u6709PPE EUA\u3002\u70ba\u4e86\u9032\u4e00\u6b65\u64f4\u5927PPE\u7684\u53ef\u7528\u6027\uff0cFDA\u9084\u901a\u904e\u6307\u5c0e\u6587\u4ef6\u767c\u5e03\u4e86\u57f7\u884c\u653f\u7b56\uff0c\u8a72\u6307\u5c0e\u6587\u4ef6\u9032\u4e00\u6b65\u63cf\u8ff0\u4e86\u5728\u4e0d\u9075\u5b88\u67d0\u4e9bFDA\u8981\u6c42\uff08\u4f8b\u5982\u8a31\u53ef\u6216\u8a3b\u518a\uff09\u7684\u60c5\u6cc1\u4e0b\uff0c\u5728COVID-19\u516c\u5171\u885b\u751f\u7dca\u6025\u60c5\u6cc1\u4e0b\u5be6\u9ad4\u53ef\u4ee5\u751f\u7522\u548c\u5206\u767cPPE\u7684\u689d\u4ef6\u3002<\/p>\n<ul>\n<li aria-level=\"1\">\u6cd5\u898f\uff1a<a href=\"https:\/\/www.fda.gov\/media\/136540\/download\" target=\"_blank\" rel=\"noopener\">FDA<\/a>\u548c<a href=\"https:\/\/content.govdelivery.com\/bulletins\/gd\/USDHSCBP-287b755?wgt_ref=USDHSCBP_WIDGET_2?utm_source=google&amp;utm_medium=google&amp;utm_term=(not%20provided)&amp;utm_content=undefined&amp;utm_campaign=(not%20set)&amp;gclid=undefined&amp;dclid=undefined&amp;GAID=338832252.1562182073?utm_source=google&amp;utm_medium=google&amp;utm_term=(not%20provided)&amp;utm_content=undefined&amp;utm_campaign=(not%20set)&amp;gclid=undefined&amp;dclid=undefined&amp;GAID=338832252.1562182073\" target=\"_blank\" rel=\"noopener\">CSMS #42448725<\/a><\/li>\n<li aria-level=\"1\">\u9632\u8b77\u8863\u4e0d\u57282020\u5e742\u67084\u65e5\u7f8e\u570b\u98df\u54c1\u548c\u85e5\u7269\u7ba1\u7406\u5c40\uff08FDA\uff09\u767c\u5e03\u7684\u201c<strong>\u7dca\u6025\u4f7f\u7528\u6388\u6b0a<\/strong>\u201d\uff08EUA\uff09\u7522\u54c1\u5217\u8868\u4e2d\u3002<\/li>\n<li aria-level=\"1\">\u5118\u7ba1\u5de5\u4f5c\u670d\u672a\u5728EUA\u4e2d\u5217\u51fa\uff0c\u4f46FDA\u57282020\u5e743\u6708\u5ba3\u5e03\uff0c\u7531\u65bcCovid-19\u5927\u6d41\u884c\u60c5\u6cc1\u548c\u91ab\u7642\u7528\u54c1\u77ed\u7f3a\uff0c<strong>FDA\u7f8e\u570b\u5c07\u514d\u9664PPE\u7684\u4e0a\u5e02\u524d\u5be9\u67e5\u8981\u6c42\u3002<\/strong><\/li>\n<li aria-level=\"1\">\u5728\u6b63\u5e38\u60c5\u6cc1\u4e0b\uff0cFDA\u8981\u6c42\u5c0d3\u7d1a\u548c4\u7d1aPPE\u9032\u884c\u4e0a\u5e02\u524d\u5be9\u67e5\u3002<\/li>\n<\/ul>\n<blockquote><p>FDA\u57282020\u5e743\u6708\u5ba3\u5e03\uff0c\u7531\u65bcCovid-19\u5927\u6d41\u884c\u60c5\u6cc1\u548c\u91ab\u7642\u7528\u54c1\u77ed\u7f3a\uff0c<strong>FDA\u7f8e\u570b\u5c07\u514d\u9664PPE\u7684\u4e0a\u5e02\u524d\u5be9\u67e5\u8981\u6c42\u3002<\/strong><\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h2>FDA\u8981\u6c42\u6709\u95dc\u9632\u8b77\u670d\u7684EUA\u689d\u4ef6<\/h2>\n<ol>\n<li>\u9632\u8b77\u670d\u7684\u95dc\u9375\u5340\u57df\uff08\u624b\uff0c\u524d\u81c2\u548c\u8ec0\u5e79\u90e8\u4f4d\uff09\u7684\u9632\u8b77\u7b49\u7d1a\u9ad8\u65bc3\u3002<\/li>\n<li>\u7b26\u5408<a href=\"https:\/\/www.law.cornell.edu\/cfr\/text\/16\/1610.61\" target=\"_blank\" 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style=\"font-size: 16px; background-color: #ffffff;\" href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/personal-protective-equipment-euas\" target=\"_blank\" rel=\"noopener\">\u53c3\u8003\u9023\u7d50<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>COVID-19\u5927\u6d41\u884c\u63a8\u52d5\u4e86\u91ab\u7642\u4fdd\u5065\u5c08\u696d\u4eba\u54e1\u548c\u516c\u773e\u5c0d\u500b\u4eba\u9632\u8b77\u8a2d\u5099\uff08PPE\uff09\u7684\u9700\u6c42\u3002\u5c0d\u65bc\u9032\u51fa\u53e3\u5546\u4f86\u8aaa\uff0c\u70ba\u4e86\u907f\u514d\u8207PPE\u9032\u53e3\u76f8\u95dc\u7684\u6311\u6230\u548c\u98a8\u96aa\uff0c\u9700\u8981\u4e86\u89e3\u4e00\u4e9b\u91cd\u8981\u7684\u7d30\u7bc0\u3002FDA\u57282020\u5e743\u6708\u5ba3\u5e03\uff0c\u7531\u65bcCovid-19\u5927\u6d41\u884c\u60c5\u6cc1\u548c\u91ab\u7642\u7528\u54c1\u77ed\u7f3a\uff0cFDA\u7f8e\u570b\u5c07\u514d\u9664PPE\u7684\u4e0a\u5e02\u524d\u5be9\u67e5\u8981\u6c42\u3002<\/p>\n","protected":false},"author":8,"featured_media":7226,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"site-sidebar-layout":"default","site-content-layout":"default","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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