Guide of Infant Formula Milk Powder China SAMR Registration

◄ Guide of Infant Formula Milk Powder China SAMR Registration ►

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Content

Introduction

CFDA ‘Administrative Measures on Product Formula Registration of Infant Formula Milk Powder’, will come into force on 1 October 2016, After then, all Infant Formula Milk Powder must apply CFDA registration, after get the approval of CFDA, then can be imported to china.

Pre-market Approval Item Name

Infant Formula Milk Powder CFDA Registration

Applicable Product Scope

infant formula milk powder
there are at most 3 series 9 kinds of formulas for one company in principle.
One series includes infant formula (0-6 months, 1 stage),
older infant formula (6-12 months, 2 stage),
and young children formula (12-36 months, 3 stage).
One wholly-owned subsidiary who has get the formula registration license and production license is allowed to produce the registered product from another wholly-owned subsidiary in the same group company. 　

License / Certificate Name

　CFDA Registration certificate for Infant Formula Milk Powder

License / Certificate Sample

License / Certificate Valid Time

5 years

Issuing Authority

CFDA - China Food and Drug Administration

Requirements of Applicant
　

Only the infant formula milk powder manufacturers who meet below requirements can apply for product formula registration:
a). have qualified R&D, production, testing capacities;
b). meet the good manufacturing practises (GMP) requirements for infant formula powder food;
c). conduct hazard analysis and critical control point (HACCP) system;
d). conduct lot by lot inspection on infant formula milk powder before they are out of factory on the basis of relevant law and national food safety standard.

Application Procedure Flow Chart

Applicant Entrust a China Responsibility Agent (CRA)
Note: CRA isn't a distributor of Applicant

CRA apply CFDA China Responsibility Agent filing
Time: 1-2 weeks　

CRA guide Applicant prepare original Legal & Technical application files
Time: 1-2 weeks　

CRA translate, Pre-view the original Legal & Technical files,
and guide Applicant modify non-compliant files until meet the requirements of CFDA
Time:1-2 months

CRA arrange products testing in the CFDA designated laboratory
Time: 3-9 months, depend on the testing items,

CRA Compile all Application Dossiers According to
the result of product test, then formal submit to CFDA
Time:2-4 weeks

CFDA relevant department Technical Evaluate the Application Documents
Time:3-6 months , depend on the CFDA

CFDA relevant department Site-audit the Applicant's production facility
Time:1- 3 months, depend on the CFDA

CFDA relevant department Sampling inspect the Applicant's product
Time:1- 3 months, depend on the CFDA

CFDA approval the application and issue certificate to Applicant
Time: 1-2 months

Application Time

1-2 years

Authority official Cost

USD $**** Contact us for Detail >>

Agent Service Fee

USD $**** Enquire us for Detail >>

Application Documents List

1.Application form
2.Qualification certificate of applicant.
3.Quality and safety standards of raw materials
4.Formula research report
5.Production process specification
6.Product testing report
7.Evidentiary materials of the production, research and testing capabilities
8.Other materials to prove the scientificity and safety of the formula
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The above is only part of application documents list, Contact us for Full List>>>

Legal basis

“Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration”

Product Test Method & Standards

Note

提示 Notice

不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

GACC Search Tools

GACC HS code, CIQ code & Tariffs

GACC Approved Food Manufacturers List

GACC Registered Overseas Food Exporters

GACC Registered Food Chinesse Importers

GACC Registration Food Categorisation

China Permitted Food Ingredients

GACC-2-2 White List for Primary Agricultural Product

China National GB Standards for Food

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◄ Guide of Infant Formula Milk Powder China SAMR Registration ►

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