随着mdr（eu 2017/745）法规的实施，欧盟市场对器械的要求越来越高。对于出口量较大的防疫物资——防护服、隔离衣、手术衣，企业有必要了解下各产品出口欧盟需遵循的合规程序。
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。
请注意：进入美国市场的食品、器械、化妆品需要申请fda注册 一、要申请fda先要找一个美国代理人 美国代理人定义
fda 化妆品注册怎么做？ fda化妆品注册（138电181话046微17信） • 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。
responsibilities of a u.s. agent the u.s. agent must either reside in the u.s. or maintain a place of business in the u.s. the u.s. agent cannot use a post office box as an address. the u.s. agent cannot use an answering service. they must be available to answer the phone or have an employee available to answer the phone during normal business hours. the responsibilities of the u.s. agent are limited and include: assisting fda in communications with the foreign establishment, responding to concerning the foreign establishment's devices that are imported or offered for import into the united states, assisting fda in scheduling inspections of the foreign establishment and if fda is unable to contact the foreign establishment directly or expeditiously, fda may provide information or documents to the u.s. agent, and such an action shall be considered to be e to providing the same information or documents to the foreign establishment. please note that the u.s. agent has no responsibility related to reporting of adverse events under the medical device reporting regulation (21 cfr part 803), or submitting 510(k) premarket notifications (21 cfr part 807, subpart e).
美国代理人
