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Intruduction

Beijing Zhoongkangluyuan Biology Co. Ltd. is a company which engage in substitutive declaration and consultation concerning with health food, disinfection products, paddle products, cosmetics, the protected traditional Chinese, medicine products, insecticidal products, enrollment of imported product brand. We have several filiales in many provinces and have engaged in this vocation for many years. We have the special group which include doctor degree, master degree, pharmaceutist personnel. We have the good relationship with the MOH, SFDA, MOA and relative inspective institution in China. We usually contact with the experts which evaluate the products. We have many advantage in this field and have succeeded in acquirint authorization of hundreds products. We have acquired ninety certification for many companies only this year. We can economize the money and time for you, We hope to service and collaborate with you cordially .

Health food generally can be called as "Functional Food" or "Dietary Supplement" in world. The definition about health food in China: this kind of food has special service-health functions, which is to say can be eaten by the given people and adjust body's function, but it's aim is not the cure. So the applied health food must have three properties: 

(1) food property; 

(2) function property;

(3) non-medicinal property.

Besides above foods provided with special functions, nutrient products have also been included into health food's administration as nutritional supplements, such as the foods for supplying nutrition, which the main materials are vitamins and minerals. These kinds of food can apply for health food permit as well. 

It is prohibited to produce, sell and import any product or nutritional supplement that claim to have health function without approval from the Ministry of Health P.R. China. 


application material

Since the period of validity for import product hygiene permit is four years, the foreign company must re-apply at six months before expiry.


application material

(1). Application form.

(2). Certificate of legal producing qualification.

(3). Certificate of applicant's qualification.

a. applicant's business licence/ register certificate which dealing in medical device.

b. applicant's business licence/ register certificate must in period of validity.

(4). The original producing country (or area)'s certificate for permitting the product into their market as medical device. 

(5). The product's technical standard. 

(6). The test's report.

(7). The clinical research report.

(8). Product specification. 

(9). Some other material making for judgement.

(10). The product quality guarantee offered by producer.

(11). The trust deed, promises and business licence/ register certificate.

(12). The guarantee for application material's truth. frequent questions 

Which products have to apply health food certificates?

The definition about health food in China: this kind of food has special service-health functions, which is to say can be eaten by the given people and adjust body’s function, but it’s aim is not the cure. So the applied health food must have three properties: 

(1) food property; 

(2) function property;

(3) non-medicinal property. 

Besides above foods provided with special functions, nutrient products have also been included into health food’s administration as nutritional supplements, such as the foods for supplying nutrition, which the main materials are vitamins and minerals. These kinds of food can apply for health food licences as well.

2. Which functions can be registered as health food in China

There are 27 kinds of functions can be accepted by Ministry of Health P. R. China

1. Enhancing Immunity

2. Assisting blood lipids reduction*

3. Assisting blood sugar reduction*

4. Anti-oxidative function*

5. Assisting memory improvement*

6. Alleviating eye fatigue*

7. Alleviating lead excretion*

8. Clear the throat*

9. Assisting blood pressure reduction*

10. Sleep improvement

11.Facilitating milk secretion*

12.Alleviating physical fatigue

13.Enhancing anoxic endurance

14.Assisting irradiation hazard protection

15.Weight control*

16.Improving child growth*

17.Increasing bone density

18.Improving nutritional anaemia*

19.Assisting the protection against chemical injury of liver

20.Eliminanting acne*

21.Eliminanting chloasma*

22.Improving skin water*

23. Improving skin oil content*

24. Regulating gastrointestinal tract flora*

25. Facilitating digestion*

26. Facilitating feces excretion*

27.Assisting the protection of gastric mucosa* 

Remark: * must do human feeding trials 3. The material needed for registration:

(1). Form of application;

(2). Product’s recipe and basis;

(3). Processing;

(4). Quality control;

(5). Toxicology evaluating report;

(6). Health function evaluating report;

(7). Health food functional components list;

(8). Functional components’ qualitative and quantitative analysis method;

(9). Stability test report;

(10). Hygienic test report;

(11). Label and explanation;

(12). Domestic and overseas information;

(13). Producing country or international organization’s relevant standard;

(14). The manufacture & free sale certificate issued by the export country (or area);

(15). The power of attorney which producer authorize agency to apply health food;

(16). Some other material according to relevant regulation or product’s properties;

The application material must include one original document and nine copies.



 
 

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