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Guide of Infant Formula Milk Powder China SAMR Registration

Tags: | SAMR | Food | Infant formula | 市场监管总局 | 食品 | 婴儿配方奶粉 |

Itmes 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
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

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