|
|
China Foods for Special Medical Purpose (FSMP) CFDA Registration Procedure Flow Chart
|
|
China Foods for Special Medical Purpose (FSMP) CFDA Registration 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?? |
![](../images/arrow2.png)
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 |
![](../images/arrow2.png)
CRA arrange products testing in the
CFDA designated laboratory Time:
3-9 months, depend on the testing items, |
CRA arrange Clinical Trial in the
CFDA designated Institution
(Only Full nutritional formula food need) Time:
3-12 months, depend on the Clinical Trial items, |
![](../images/arrow2.png)
CRA Compile all Application Dossiers According
to the result of product test and Clinical Trial, then formal submit to
CFDA Time:2-4weeks |
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 |
![](../images/arrow2.png)
CFDA relevant
department Sampling inspect the Applicant's product Time:1-
3months, depend on the CFDA |
![](../images/arrow2.png)
CFDA approval the application and issue
FSMP certificate to
Applicant Time: 1-2 months |
|
|
|
|
|