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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
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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 |
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| Note |
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