803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的...
803 医疗器械报告 MEDICAL DEVICE REPORTING 806 医疗器械;改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 对州和地方医疗器械要求的...
? ?概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务部食品与药品管理局(Food and Drug Administration,Department of Health and Human Services...
我们在本部分中使用的一些术语特定于医疗器械报告,并反映了法规(法律)中使用的语言。其他术语更为笼统,反映了我们对法律的解释。本节定义了以下术语Some of the terms we use in this part are specific to medical device reporting and reflec
食品和药物. 第803部分:医疗器械报告. 第803.13节:我需要提交英文报告吗? Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.13:Do I need to submit reports in English? CFR 21-803.13-2014 发布历史 CFR 21-803.13-2014由US-CFR-file 发布于 2014-02-14,并于 2014-02-...
中文标准名称:CFR 21-803.53-2014 食品和药物. 第803部分:医疗器械报告. 第803.53节:如果我是一个制造商,在何种情况下,我必须提交一份为期5天的报告? 英文标准名称:Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.53:If I am a manufacturer, in which circumstances must I...
(a),(c),and(f)).NOTETO§801.437:Paragraphs(f)and(g)arestayeduntilJune27,1999,asthoseregula-tionsrelatetodevicepackagingthatuses‘‘coldseal’’adhesives.[62FR51029,Sept.30,1997,asamendedat63FR46175,Aug.31,1998]PART803—MEDICALDEVICEREPORTINGSubpartA—GeneralProvisionsSec.803.1Whatdoesthispart...
(a),(c),and(f)).NOTETO§801.437:Paragraphs(f)and(g)arestayeduntilJune27,1999,asthoseregula-tionsrelatetodevicepackagingthatuses‘‘coldseal’’adhesives.[62FR51029,Sept.30,1997,asamendedat63FR46175,Aug.31,1998]PART803—MEDICALDEVICEREPORTINGSubpartA—GeneralProvisionsSec.803.1Whatdoesthispart...
概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)共有9卷(Volume)、3章(Chapter)、1499部(Parts)。其中:第1―8卷第1章第1―1299部,为健康与人类服务 部食品与药品管理局(Food and Drug Administration,Department of Health and Human Services)的...