办理国家药监局进口化妆品备案批文所需资料
（一）检测所需材料：
1、产品中、英文名称； DEION OF GOODS
2、国外公司中、英文名称，中、英文地址，产品颜色形状，生产日期，保质期；
Name of seller, seller’s add. both in English and Chinese. Color of goods, shape of goods, product date, guarantee period
3、产品配方说明（提供使用目的）；Preion in details（use for purpose）
4、特殊用途化妆品应提供功效成份、使用依据及功效成份检验方法的相关资料；
Goods in special purpose have to provide the effect, component, working principle, efficacy inspection and other information in details.
5、送检样品若干；（普通类提供带完整包装同一批号的样品14个；特殊类依据不同具体类别确定样品数量）（14个/≤10g,总150g）
Several samples for inspection (common products: each block in same type 14 samples in need; Special type: according to the number of type. Each type need several samples) (14pcs/≤10g,total:150g)
6、产品说明书；Instruction of goods
（二）申报阶段所需材料：Documents for apply
7、产品质量标准及检验方法，并附中文译本（各3份）（企业标准）；
The Quality Standard of goods and way of inspect. Translate into Chinese in 3 copys. (enterprise standard)
8、生产工艺及简图；Manufacturing technique and drawing paper
9、产品原包装（中文译本）；Original package(Translate into Chinese)
10、产品在生产国或原产国允许生产销售的证明文件；
Certificate of product permit or the sales permit in country of origin.
11、生产企业授权国内在华责任单位的授权书。Letter of attorney to the company in China.
12、如果国外化妆品企业是委托加工的，应当提供生产厂的ISO9001等质量体系认证证书或GMP证书的复印件，同时提供发证单位的证明材料；
If it is a manufacturing consignment good, copy of ISO9001 certificate or GMP certificate must be provided by the foreign manufacture, and providing the certificates issued by the Competent authority.
13、产品在其他国家注册和批准销售的证明文件（复印件3份）；
Certificate of register and sales permit in other countries. (3 copys)
14、产品在生产国和其他国家通过生产、注册、销售批准审查的评价报告，并附中文译本（各5份）；
Assessment report of production to be product registered sales permit in other countries in 5 folds. And one copy in Chinese in 5 folds.
15、产品卫生安全性评价资料或产品卫生质量检验报告（5份）
Assessment report of health and safety or the quality inspection. (5 folds)
16、产品标签、使用说明书，并附中文译本（各3份）；Production marks, instruction, Copy in Chinese (3 folds each doc.)
17、代理申报的，应提供委托代理证明； for agency, provide agency for agreement
18、可能有助于评审的其它资料
