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CFDA Registration expense and timetable for Healthy food

Tags: | SAMR | Food | Health Food | 市场监管总局 | 食品 | 保健食品 |

  

In China, Health Foods are divided into 2 parts, they are Nutritional supplements (Dietary supplements) and Function Healthy Foods

1. Nutritional supplements (Dietary supplements) : Such as:Vitamin, Calcium tablet, etc. Nutritional supplements only can be made nutrient content claims.

2. Function Healthy Foods : Such as: Deep Sea Fish Oil, Ginseng tablets, etc.. Function Healthy Foods can be made health claims or structure/function claims,

l The following is the CFDA registration general cost for Healthy Foods

1.The CFDA relation goverment fees(charge According to the actual cost):

Item

Fee

Time

Toxicology, hygienic, stability, active ingredient tests:

Both Nutritional supplements and Function Healthy Foods are required,

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4 Months

Function Tests & Human Trial Study

Function Healthy Foods Only

Animal study only:

1. Enhancing immune systems

2. Sleep improvement

3. Alleviating physical fatigue

4. Enhancing anoxia endurance

5. Irradiation hazard protection function

6. Increasing bone density

7. Assisting liver protection against injury

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6-9 Months

Human study only:

8. Alleviating eye fatigue

9. Eliminating acne

10. Eliminating skin pigmentation

11. Improving skin ability to retain moisture

12. Improving skin oil content function

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8-12 Months

Both Animal & Human studies are required:

13. Assisting blood lipids reduction

14. Assisting blood sugar reduction

15. Anti-oxidative function

16. Assisting memory improvement

17. Alleviating lead excretion

18. Improving throat function

19. Assisting blood pressure reduction

20. Facilitating milk secretion

21. Assisting weigh control

22. Improving child growth

23. Improving nutritional anemia

24. Regulating gastrointestinal flora

25. Facilitating digestion (regularity)

26. Facilitating bowel movement

27. Protection of gastric mucosa

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12-18 Months

Doping test: only for the 3 functions of the follow

3. Alleviating physical fatigue

21. Assisting weigh control

22. Improving child growth

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1 Months

CFDA Evaluation & Approval

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6 Months

Total

18-24 Months

l Multi-function claim, need more time and expense.

2.The china legal agent service Fees:

1) for Nutritional Supplements (Dietary supplements) :

ITEM

Agent Fees

TIME

NOTE

China CFDA Registration consulting & Legal responsibility Agency

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0.5-1 Months

Technical documents Prepare & Translation

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0.5-1 Months

CFDA Application Dossier Draft, Review & Submit

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1 - 2 Months

Toxicology, hygienic, stability, active ingredient tests follow up

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4 - 6 Months

CFDA Evaluation & Approval follow up

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6 - 8 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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