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China Foods for Special Medical Purpose (FSMP) SAMR 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 

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