510(k) Premarkethttp://Notificationwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm FDA产品分类(Product Classification):可以访问FDA官网的产品分类页面,在该页面上根据产品的特征和用途,查询产品的分类信息。 Product Classification (http://fda.gov)http://www.accessdata.fda.gov/scripts/cdrh/cf...
在Product Code栏中输入HKP。 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm 打开第一个Aaron Vac2。如果有510K Summary,就可以下载。 如果产品是需要PMA的,比如,870.3610 Implantable pacemaker pulse generator。则到Product Classification中...
www.fda.gov/medical-devices/classify-your-medical-device/device-classification-panels Q:510(k)申请流程? A:详见下表所示~ 内容获取周期(大概)备注①确定产品代码Product Code1工作日不同类别产品通常有不同代码②确定比对产品确定具体上市产品作为比对器械3-5工作日需要和申请的产品属于同类或非常类似③确定测试标...
相关产品:美国医疗器械分类目录 , FDA , medical , device , classification , list 所属分类:中国商务服务网/医药行业认证 本页链接:http://product.11467.com/info/20858708.htm 美国医疗器械分类目录 FDA medical device classification list的文档下载:PDFDOCTXT ...
A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan. Molecular Pharmaceutics. 2006;3:631643. 2. World Health Organization. Proposal to waive in vivo bioequivalence requirements for the WHO Model List of Essential ...
1402 强制性解密审查 MANDATORY DECLASSIFICATION REVIEW 1403 对给予州和地方政府资金和合作协议的统一行政要求 UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS 1404 政府范围的排除与暂停(非获得) GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) 1405 ...
1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES ...
1309 表I化学品的制造者、分销者、进口者和出口者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS 1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved] 1312 管制物质的进口与出口 ...
___ is de-signed to evaluate the quality system implemented according to the FDA Quality System Require-ments (QSR ’s) as given in 21 CF R § 820, ISO 9001/2, and EN 46001/2. There was a particular em-phasis on the use of the ISO 9001/2, EN 46001/2 audit check list provided...
Regulatory Applicability 法规的适用性 Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this...