CFDA Registration Application Guide of Foods for Special Medical Purpose (FSMP)

◄ CFDA Registration Application Guide of Foods for Special Medical Purpose (FSMP) ►

Itmes

Content

Introduction

CFDA “Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration” came into force on 1 July 2016. After now, all Foods for Special Medical Purpose (FSMP) must apply CFDA registration, after get the approval of CFDA, then can be imported to china.

Pre-market Approval Item Name

Foods for Special Medical Purpose (FSMP) CFDA Registration

Applicable Product Scope

I. Full nutritional formula food
These products can be used as a single source of nutrition for targeted population requirements.
II. Specific Full nutritional formula food
These products can be used as a single source of nutrients to meet targeted groups requirements in a particular disease or medical condition. There are 13 categories of specific full nutritional formula foods below:
1. Full nutritional formula food for diabetics;
2. Full nutritional formula food for respiratory system disease patients,
3. Full nutritional formula food for kidney disease patients;
4. Full nutritional formula food for cancer patients;
5. Full nutritional formula food for hepatopaths,
6. Full nutritional formula food for muscle attenuation syndrome patients,
7. Full nutritional formula food for patients with trauma, infection, surgery or other stress condition,
8. Full nutritional formula food for patients with inflammatory bowel disease;
9. Full nutritional formula food for food protein allergy sufferers;
10. Full nutritional formula food for patients with intractable epilepsy;
11. Full nutritional formula food for patients with gastrointestinal disorders, pancreatitis;
12. Full nutritional formula food for patients with fatty acid metabolism,
13. Full nutritional formula food for patients with obesity, fat reducing surgery.
III. Part nutritional formula food
These products can be used to meet the targeted population requirements of part nutrition and cannot be a single source of nutrients. There are 5 categories of part nutritional formula food below:
1. nutrient components (protein components, fat components, carbohydrate components),
2. the electrolyte formula,
3. thickening components,
4. liquid formulation
5.amino acid metabolism disorder formula.
IV. FSMP for 0 to 12 months old infant

lactose formula or low lactose formula food l

Partially hydrolyzed milk protein formula food l

Completely hydrolyzed milk protein formula food or amino acid formula food l

Premature delivery or low birth weight infant formula food l

Amino acid metabolism disorder formula food l

Breast milk nutritional supplements　

License / Certificate Name

　CFDA Registration certificate for FSMP

License / Certificate Sample

License / Certificate Valid Time

5 years

Issuing Authority

CFDA- China Food and Drug Administration

Requirements of Applicant
　

Only the FSMP manufacturers could apply for FSMP registration. Meanwhile, the applicants above must meet all the following three requirements: (1) Set up the independent R&D institutions and should be equipped with full-time product R&D personnel, food safety executive personnel and food safety professional and technical personnel; (2) According to good manufacturing practices standards requirements, establish corresponding production quality management system; (3) Have the ability to complete all test items according to the Food Safety National Standard (GB) for FSMP.

Application 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

Application Time

1-2 years

Authority official Cost

USD $**** Contact us for Detail >>

Agent Service Fee

USD $**** Enquire us for Detail >>

Application Documents List

1. FSMP registration application form
2. Product R&D report, formula design and its theoretical foundation
3. Manufacturing process materials
4. Requirements for product quality standard
5. Product label sample and specification sample
6. Sampling testing reports
7. R&D, manufacture and testing capability proof materials
8. Other materials that can improve product safety, nutritional sufficient and special medical clinical effect
9. Clinical trial report (only specific full nutritional formula foods required)
10. Registration application relevant certificates,
11. Other relevant material
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The above is only part of application documents list, Contact us for Full List>>>

Legal basis

“Administrative Measures on Foods for Special Medical Purpose (FSMP) Registration”

Product Test Method & Standards

Note

提示 Notice

不同类型的GACC注册，海外申请人可以根据自身情况，选择不同的渠道进行注册申请。
1. 如果你精通GACC注册流程，可以直接向中国海关提交免费申请，其网站为：www.customs.gov.cn or www.singlewindow.cn；
2. 如果你是第一次申请，不清楚GACC注册的程序h流程，申请文件要求等，可以通过CRA中国代理机构渠道申请注册，CRA会提供专业的注册咨询服务，帮助你顺利通过GACC注册审查，尽快获得GACC注册号。

Different types of GACC registration, overseas applicants can choose different channels to apply for :
1. If you specialise in the GACC registration process, you can submit a free application directly to China Customs, website: www.customs.gov.cn or www.singlewindow.cn;
2. If you are not clear about the registration process of GACC registration, application document requirements, etc., you can apply for registration through the channel of CRA (Chinese Representative Agency) , CRA will provide professional registration services to help you successfully pass the GACC registration review and get the GACC registration number quickly.

GACC Search Tools

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China Permitted Food Ingredients

GACC-2-2 White List for Primary Agricultural Product

China National GB Standards for Food

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