口罩欧代MDD指令+注册+技术文档+符合性声明办理
MDD/MDR法规),全套CE技术文件编订, CE第四版临床评价(MEDDEV 2.7.1 Rev 4)编写,欧盟授权代表,欧盟自由销售证书,ISO13485:二016,(MDSAP)审核、美国FDA注册(含FDA510K申请),FDA美国代理人服务/ FDA QSR820验厂辅导及整改,FDA警告信应对&RED LIST 商,欧盟授权代表,进口商和分销商 •直接供给的卫生机构或医疗保健专业人员(Article 25). • Store and keep the UDI for implantable devices by economic operators (Article 27.8) • Electronic system for registration of economic operators (Article 30+Annex VI, Part A) Regulatory compliance • It should be ensured that supervision and control of the manufacture of devices, and the post-market surveillance and vigilance activities concerning them, are carried out within the manufacturer’s organisation by a person responsible for regulatory compliance who fulfils minimum conditions of qualification. • The authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union… legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general
免责声明:当前页为 口罩欧代MDD指令+注册+技术文档+符合性声明办理产品信息展示页,该页所展示的 口罩欧代MDD指令+注册+技术文档+符合性声明办理产品信息及价格等相关信息均有企业自行发布与提供, 口罩欧代MDD指令+注册+技术文档+符合性声明办理产品真实性、准确性、合法性由店铺所有企业完全负责。世界工厂网对此不承担任何保证责任,亦不涉及用户间因交易而产生的法律关系及法律纠纷,纠纷由会员自行协商解决。
友情提醒:世界工厂网仅作为用户寻找交易对象,就货物和服务的交易进行协商,以及获取各类与贸易相关的服务信息的渠道。为避免产生购买风险,建议您在购买相关产品前务必确认供应商资质及产品质量。过低的价格、夸张的描述、私人银行账户等都有可能是虚假信息,请您谨慎对待,谨防欺诈,对于任何付款行为请您慎重抉择。
投诉方式:fawu@gongchang.com是处理侵权投诉的专用邮箱,在您的合法权益受到侵害时,请将您真实身份信息及受到侵权的初步证据发送到该邮箱,我们会在5个工作日内给您答复,感谢您对世界工厂网的关注与支持!
电话18025352867
手机15310417507
地址惠州市惠阳区淡水东华大道和白云路交汇处诚杰国际商业中心A幢36层02号