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CFDA Registration Application Guide of Foods for Special Medical Purpose (FSMP)
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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
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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?? |
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License / Certificate Name |
??CFDA Registration certificate for FSMP |
| License / Certificate Sample |
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| License / Certificate Valid Time |
5 years |
| Issuing Authority |
CFDA- China Food and Drug Administration |
Requirements of Applicant
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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.
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| Application Procedure Flow Chart |
Applicant Entrust a China Responsibility Agent (CRA)
Note: CRA isn't a distributor of Applicant
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CRA apply
CFDA
China Responsibility Agent filing
Time: 1-2 weeks??
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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 |
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| 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 |
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| Note |
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