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