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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??

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  
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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Important Note
Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all
CFDA and SFDA on this website default to NMPA, GACC defaults to GACC; 
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