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China Foods for Special Medical Purpose (FSMP) SAMR Registration Procedure Flow Chart

Tags: | SAMR | Food | Foods for Special Medical Purpose | 市场监管总局 | 食品 | 特殊用途食品 |

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