轮椅车及代步车ce认证适用标准是： en 12183-2014 手动轮椅车要求及测试方法 en 12184-2014 电动轮椅和踏板车及其充电器的要求及测试方法 en 60601-1:2006/a1:2013 电气设备-第1部分：基本安全和重要性能的一般要求 en 60601-1-2:2015 电气设备-第1-2部分：基本安全和重要性能的一般要求-并行标准：电磁干扰-试验和要求 其中en 12183测试标准适用于载重不超过250kg的手动轮椅车以及带电动设备的手动轮椅。en 12184则适用于大速度不超过15 km/h，用于携带一个且载重不超过300 kg的电动轮椅车及带有三个或更多轮子的电动踏板车。
哪些企业需要进行fda的企业注册 从下图可以看出，在美国本土外的器械制造商，器械出口商，分包制造商，分包灭菌服务提供方，器械设计开发者以及器械的再加工，再生产和再贴牌的厂家都需要进行企业注册并且需要按照fda的要求缴纳年金。
fda对于美国代理人的解释也可以参考看一下网站的原文： any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the united states must identify a united states agent (u.s. agent) for that establishment. information about a foreign establishment’s u.s. agent is submitted electronically using the fda unified registration and listing system (furls system) and is part of the establishment registration process. each foreign establishment may designate only one u.s. agent. the foreign establishment may also, but is not required to, designate its u.s. agent as its official correspondent. the foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the u.s. agent. the u.s. agent identified will be required to complete an automated process to confirm that they have agreed to act as the u.s. agent. the automated process will forward an email verification request to the u.s. agent. they will be re to confirm her/his consent to act as a representative/liaison on behalf of the foreign establishment. if the u.s. agent denies consent (or does not respond within 10 business days), the official correspondent/owner operator of the foreign establishment will be notified and must designate a new u.s. agent to satisfy the regulatory obligation.
每年更新fda 要求： • 1) 注册和登记每年要更新一次（更新时间是：10月1号到12月31号 • 2) 要随时通知fda注册和登记内容的变化。 – ii 类产品，在进行设施登记和器械注册后，还需递交“上市前通知” 即510(k)申请。只有个别产品510(k) 豁免。
化妆品fda注册 fda化妆品注册 1/ 化妆品企业注册可以在出口美国之前或者出口之后（30天内）； 2/ 化妆品产品注册需要有1000美金的出口之后，但是实际上fda无法核对； 3/ can i file formulations in the vcrp for products that are considered drugs but also have a cosmetic function? 对于药品有化妆品功能的是否可以做化妆品注册？ yes, products that are considered drugs in the united states, such as sunscreens, but also make cosmetic type claims, such as moisturizing, can be filed in the vcrp. 4/ 可以进行化妆品注册，但是这并不能豁免其需要同时满足药品的相关要求的职责。 办理化妆品的fda相对来说比较简单，企业提供企业信息以及产品成分表（中英文）就可以了。
510K认证