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 |
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 arrange Clinical Trial in the
CFDA designated Institution
(Only Full nutritional formula food need)
Time:
3-12 months, depend on the Clinical Trial items, |
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 |
CFDA relevant
department Sampling inspect the Applicant's product
Time:1-
3months, depend on the CFDA |
CFDA approval the application and issue
FSMP certificate to
Applicant
Time: 1-2 months |
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