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详细页面 当前位置:网站首页 » 服务项目 » 化妆品备案/注册 » 进口化妆品申报过程和所需资料(中英文)- 广州汉智

进口化妆品申报过程和所需资料(中英文)- 广州汉智

文章来源:admin    时间:2017-01-18 05-26-00

进口化妆品申报过程和所需资料

  • cosmetic registration process and required information



一、项目启动,提供在华申报责任单位授权书(签订协议后我公司提供模板)(药监局审批时间5个工作日)

 Providing authorization to the responsible units in China .(We will provide the template for you after signing agreement. )(SFDA need 5 workdays for approval)


二、样品检测(时间3个月)

 sample testing(3 months)

1、贵公司只需提供产品配方、说明书和送检样品;生产企业的基本信息。

You only need to provide product formulas, specifications and testing samples; basic information of manufacturer.

2、送样品检验(19个样品,根据产品规格来定)。

To send samples for testing.


 三、准备申报资料(我公司准备,在做检验同时完成)。

Preparing registration documents .(We complete it during the testing period.)

(1)化妆品卫生许可申请表 (我公司准备)

 Cosmetic sanitation license application form(We complete it)

(2)产品命名依据(国外公司准备,但我公司需要审核)

 The named basis(Prepared by foreign company,but we need to review it.)

(3)产品配方(100%复配成分表,含有PEG/SLS/SLES/AES等成分的需要原料厂商提供COA证明,里面要求含有二恶烷的含量证明) (国外提供,但我公司需要审核)

Product formula (100% compound ingredients list,please provide the COA or specification of PEG/SLS/SLES/AES,which should include the wt% of dioxane)(Prepared by foreign company,but we need to review it.)

提供全部原料的名称(INCI名称),实际含量以百分比计算,并注明有效物含量(未注明者均已有效物含量100%计算)

Raw material name list(INCI names),with actual contents in percentage,and should indicate the active material contents(determination of 100% active material content if not specified) 

成分百分比降序排列

Ingredients percentage,in descending order 

成分的使用目的(功效)

the using purpose or efficacy of ingredients 

复配原料必须以复配形式申报,并注明各组分在其中的含量

 the declaration must be in form of compound for any Compound raw materials,and specify each ingredient contents.

凡在配方中使用来源于石油、煤焦油的碳氢化合物(单一组分除外的,应在产品配方中标明相关原料的化学文摘索引号及CAS号)

for formula coming from OIL ,coal tar hydrocarbons,the Chemical Abstracts index number(CAS number)of raw materials should be marked.

(4) 如成分中有植物提取物,需国外厂商提供成分中植物提取物是否有农药残留的证明。(国外提供,但我公司需要审核)

If there are plant extract in the ingredients,the foreign company should provide a certificate of whether having pesticide residue or not. Prepared by foreign company,but we need to review it.)

(5)安全性风险评估资料,根据配方由国外厂商提供(我公司提供需要额外付费)

Information of security risk assessment,provided by foreign company according to formulas.

(6)产品质量安全控制要求 (生产企业内控标准)(国外提供,但我公司需要审核)

Product quality and safety control requirements (internal control standards of manufacturer)(Prepared by foreign company,but we need to review it.)

颜色、气味、性状等感官指标

sensory indexes of color,smell,characters,etc. 

微生物指标、卫生化学指标

microbial index,chemical and hygienic indexes. 

PH值指标

 PH value index

(7)药监局认可的检验机构出具的检验报告及相关材料(我公司准备)

Testing report issued by inspection department accepted by SFDA and related information.(We complete it)

(8)产品原包装(含产品标签),拟为中国市场设计包装上市的,需同时提供产品设计包装(含产品标签)(我公司准备)

Product original packaging (including product label), the packaging to be designed for the Chinese market, and is required to provide product packaging design (including the product label) (We complete it)

(9)经公证的自由销售证明(需要国外提供,签合同后我公司可提供样本)

 Notarized certificate of Free sale(prepared by foreign company,We will provide the template for you after signing agreement.)

 内容应包括生产企业名称、产品名称、出具文件的机构名称并有机构的印章或签名以及出具文件的日期,里面需要体现出该系列产品允许在本国及外国自由生产及销售。

 Issued by production country,or its local authority or industry Association.The content includes manufacturer name,product name,issued by which organization with its official seal,or signature from legal representative(authorized person),and should be reflected in production and sale.

(10)化妆品使用原料及原料来源符合疯牛病疫区高风险物质禁限用要求的承诺书(我公司准备)

 Cosmetics raw materials and raw materials source meet the high risk of BSE infected material Restriction of the undertaking required. (We complete it)

(11)在华责任单位营业执照复印件并加盖其公章(在华单位准备)

The copy of business license with a official seal of responsible unit in China .(The responsible unit in China)

(12)另附许可检验机构封样的样品一件(我公司准备)

Attached a sealedsample of injection department.(We complete it)

(13)如果是委托加工生产形式,需要企业出具被委托生产企业的质量管理体系或良好生产规范的证明文件或符合生产企业所在国(地区)法规要求的化妆品生产资质证明文件。并提供委托加工协议原件。

 If the production way is consigned processing,please provide the Quality Management System or Good Manufacture Practice or cosmetic production qualification document in line with manufacturers of the country (region) regulatory of the commissioned manufacturer .And provide the original agreement of consigned processing .

(14)如果是宣称为孕妇、哺乳期妇女、儿童或婴儿使用的产品,应当提供基于安全性考虑的配方设计原则(含配方整体分析报告)、原料的选择原则和要求、生产工艺、质量控制等内容的资料。

If the product is claimed to be used for pregnant,lactating women or children,it should provide the design principle of formula(including the whole analysis report of formula),selection principle of raw material and requirements,manufacturing technique,quality control and so on that based on security.

(15)生产工艺简述及生产工艺简图

Production flow chart and brief

(16)申请育发、烫染发、健美、美乳类、除臭、祛斑、防晒产品的,应提交功效成份、使用依据(含文献资料论文、发表的期刊复印件等)

Grower/Hair Perm/Hair Dyes/Slimming/ Breast Beautifying/Deodorant/Spot Removal/Sunscreen products shall be submitted to the efficient ingredients, use basis (including the literature material thesis, the journal published copies, etc.)


四、资料送交药监局5个工作日做出答复是否受理。(5个工作日)

After all the documents sended to SFDA,we can know whether the products accepted or not within 5 workingdays. 


五、药监局受理后行政签字,签发批文。(31个工作日)

After the documents accepted by SFDA,then there is the administration signature,sign and issue the certificate。


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