{"id":284,"date":"2020-08-24T23:12:39","date_gmt":"2020-08-24T15:12:39","guid":{"rendered":"http:\/\/unionmedin.com\/?p=284"},"modified":"2023-12-17T13:34:54","modified_gmt":"2023-12-17T05:34:54","slug":"%e5%85%a8%e7%90%83%e5%8c%bb%e7%96%97%e5%99%a8%e6%a2%b0%e4%b8%8d%e8%89%af%e4%ba%8b%e4%bb%b6%e7%9b%91%e6%b5%8b%e5%8f%91%e5%b8%83%e6%9f%a5%e8%af%a2%e8%b7%af%e5%be%84-2","status":"publish","type":"post","link":"https:\/\/unionmedin.com\/?p=284","title":{"rendered":"\u5168\u7403\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u76d1\u6d4b\u53d1\u5e03\u67e5\u8be2\u8def\u5f84"},"content":{"rendered":"<section style=\"margin:0px;padding:0px;max-width:100%;color:#333333;font-size:17px;font-style:normal;font-weight:normal;letter-spacing:0.544px;text-align:justify;text-indent:0px;text-transform:none;background-color:#FFFFFF\" data-style-type=\"9\" data-id=\"13440\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:20px 0px 0px;padding:10px 10px 0px;max-width:100%;border-radius:10px;background:#FFFFFF\">\n<section style=\"margin:0px;padding:0px;max-width:100%;letter-spacing:1px;line-height:24px;color:#4C1130\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t<br class=\"Apple-interchange-newline\" \/><br \/>\n \u4e2d\u56fd-\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u53d1\u5e03\uff1a\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u4e2d\u56fd-\u300a\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\u901a\u62a5\u300b\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttp:\/\/www.cdr-adr.org.cn\/ylqx_1\/Medical_aqjs\/Medical_aqjs_xxtb\/\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u4e2d\u56fd-\u300a\u533b\u7597\u5668\u68b0\u8b66\u6212\u5feb\u8baf\u300b\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttp:\/\/www.cdr-\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\tadr.org.cn\/ylqx_1\/Medical_aqjs\/Medical_aqjs_jjkx\/\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:657px;border-bottom:2px solid #A64D79\"><\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><\/section>\n<p><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u7f8e\u56fd-\u4e0d\u826f\u4e8b\u4ef6\u67e5\u8be2\u6570\u636e\u5e93MAUDE\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfmaude\/search.cfm\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t  \u7f8e\u56fd-\u53ec\u56de\u67e5\u8be2\u6570\u636e\u5e93Recall\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfRES\/res.cfm\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t  \u7f8e\u56fd-\u6309\u5e74\u4efd\u67e5\u8be2\u8b66\u544a\u4fe1\uff08warning letter\uff09\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.fda.gov\/drugs\/enforcement-activities-fda\/warning-letters-and-notice-violation-letters-pharmaceutical-companies\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:557.5px;border-bottom:2px solid #A64D79\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u82f1\u56fd-\u533b\u7597\u5668\u68b0\u8b66\u62a5\uff08MHRA\uff09\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.gov.uk\/drug-device-alerts?keywords=&#038;alert_type[]=devices&#038;issued_date[from]=&#038;issued_date[to]=\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:557.5px;border-bottom:2px solid #A64D79\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u52a0\u62ff\u5927-\u53ec\u56de\u548c\u8b66\u6212\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/healthycanadians.gc.ca\/recall-alert-rappel-avis\/index-eng.php\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:557.5px;border-bottom:2px solid #A64D79\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u6fb3\u5927\u5229\u4e9aTGA-\u4e0d\u826f\u4e8b\u4ef6\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/apps.tga.gov.au\/prod\/DEVICES\/daen-entry.aspx\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u6fb3\u5927\u5229\u4e9aTGA-\u53ec\u56de\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttp:\/\/apps.tga.gov.au\/PROD\/SARA\/arn-entry.aspx\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u6fb3\u5927\u5229\u4e9aTGA-\u8b66\u6212\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.tga.gov.au\/all-alerts\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:557.5px;border-bottom:2px solid #A64D79\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u65e5\u672cPMDA\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.pmda.go.jp\/english\/safety\/info-services\/devices\/0002.html\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%\" data-style-type=\"\u5206\u9694\" data-id=\"12565\" data-tools=\"\u65b0\u5a92\u4f53\u6392\u7248\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;border-width:0px;border-style:none;border-color:initial\">\n<section style=\"margin:0.5em 0px;padding:0px;max-width:100%;overflow:hidden\">\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em\">\n<section style=\"margin:0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<section style=\"margin:0px -1em;padding:0px;max-width:100%;vertical-align:middle;width:557.5px;border-bottom:2px solid #A64D79\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<section style=\"margin:0px;padding:0px;max-width:100%;vertical-align:middle;width:1em;height:1em;border-radius:100%;background-color:#741B47\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u5fb7\u56fdBfArM-\u53d1\u5e03FSCAs\uff08Field Corrective Actions\uff09\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\thttps:\/\/www.bfarm.de\/SiteGlobals\/Forms\/Suche\/EN\/kundeninfo_Filtersuche_Formular_en.html?nn=4527724\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;text-align:center\">\n<\/section>\n<section style=\"margin:10px 0px 0px;padding:0px;max-width:100%\">\n<section style=\"margin:0px;padding:0px;max-width:100%;text-align:right;width:278.889px;vertical-align:middle\">\n<section style=\"margin:0px;padding:0px;max-width:100%;width:60px\"><br style=\"margin:0px;padding:0px;max-width:100%\" \/><br \/>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em;color:#333333;font-size:17px;font-style:normal;font-weight:normal;letter-spacing:0.544px;text-align:justify;text-transform:none;background-color:#FFFFFF;text-indent:28px\">\n\t\n<\/p>\n<section style=\"margin:0px;padding:0px;max-width:100%;color:#333333;font-size:17px;font-style:normal;font-weight:normal;letter-spacing:0.544px;text-align:justify;text-indent:0px;text-transform:none;background-color:#FFFFFF\" data-role=\"paragraph\">\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\n<\/p>\n<p style=\"margin:0px;padding:0px;max-width:100%;clear:both;min-height:1em\">\n\t\u6765\u6e90\uff1aCMDE\n<\/p>\n<\/section>\n","protected":false},"excerpt":{"rendered":"<p>\u4e2d\u56fd-\u56fd\u5bb6\u836f\u54c1\u4e0d\u826f\u53cd\u5e94\u76d1\u6d4b\u4e2d\u5fc3\u53d1\u5e03\uff1a \u4e2d\u56fd-\u300a\u533b\u7597\u5668\u68b0\u4e0d\u826f\u4e8b\u4ef6\u4fe1\u606f\u901a\u62a5\u300b http:\/\/www.cdr-adr 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