CFDA Registration cost and timetable for Nutritional supplements(Dietary supplements) of China

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CFDA Registration cost and timetable for Nutritional supplements(Dietary supplements)

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￡o

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,		Inquire us	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	Inquire us	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	Inquire us	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	Inquire us	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		Inquire us	1 Months
CFDA Evaluation & Approval		Inquire us	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	Inquire us	0.5-1 Months
Technical documents Prepare & Translation	Inquire us	0.5-1 Months
CFDA Application Dossier Draft, Review & Submit	Inquire us	1 - 2 Months
*Toxicology, hygienic, stability, active ingredient tests follow up*	Inquire us	4 - 6 Months
CFDA Evaluation & Approval follow up	Inquire us	6 - 8 Months
Other (Document Notarization etc.)	USD$500	0.5-1 Months
Total:	Inquire us	18-24 Months

2) for Function Healthy Foods:

ITEM	Agent Fees	TIME	NOTE
China CFDA Registration consulting & Legal responsibility Agency	Inquire us	0.5-1 Months
Technical documents Prepare & Translation	Inquire us	0.5-1 Months
CFDA Application Dossier Draft, Review & Submit	Inquire us	1 - 2 Months
*Toxicology, hygienic, stability, active ingredient tests follow up*	Inquire us	4 - 6 Months
Function tests /Animal Study (for Function No. 1-7)*	Inquire us	*4 ¨C 16 Months*
Function tests/Human Trial (for Function No. 8-12)*	Inquire us	*8 - 12 Months*
Function tests/Human Trial + Animal Study (for Function No. 13-27)*	Inquire us	*12 - 18 Months*
CFDA Evaluation & Approval	Inquire us	5 ¨C 8 Months
Other (Document Notarization etc.)	Inquire us	0.5-1 Months
Total:	Inquire us	24-36 Months

l Multi-products registration,the agent fee can discount

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Important Note

Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all CFDA and SFDA on this website default to NMPA, GACC defaults to GACC;　

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