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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  
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


Risky Food Export China Process
In China, the imported food is divided into 4 risk levels from low to high : A, B, C, D ; Different levels of supervision are adopted for foods with different risk levels;

The medium to high risky imported food categories include:Meat products, aquatic products, dairy products, sausage casings, bird nest products, bee products, egg products, edible oils and fats, oilseeds, stuffed wheaten products, edible grains, milled grain industry products and malt, fresh and dehydrated vegetables and dried beans, condiments, nuts and seeds, dried fruits, unroasted coffee beans and cocoa beans, foods for special dietary purposes, and health foods, Animal feed etc.

Dairy
Products

Meat
Products

Aquatic
Products

Animal
Feeds

GMO
Agriculturals

Dietary
Supplements

Infant
Formula

Fresh
Foods
More...

In addition to the above-mentioned general food import procedures, the risky imported food also need to go through other government procedures of Manufacturer Registration / Certifcation, Pre-market approval of the product etc.
 
The common China's government departments include :
Learn More China Pre-market Approval >>>
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