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How to apply for US FDA certification,American FDA certificate

How to apply for US FDA certification,American FDA certificate

How to apply for US FDA certification,American FDA certificate

Product Details:

Place of Origin: CHINA
Brand Name: ZKT
Certification: FDA
Model Number: ZKT
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The Food and Drug Administration, or FDA, is one of the government's executive agencies in the department of health and human services and the public health department. As a scientific regulator, the FDA is responsible for ensuring the safety of foods, cosmetics, medicines, biological agents, medical equipment and radiological products produced or imported in the United States. It was one of the first federal agencies to focus on protecting consumers.
The agency is linked to the lives of every American citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries promote and monitor the safety of their products by seeking and receiving FDA help.
In charge of the food and drug administration (FDA) : food, medicine, including veterinary medicine), medical equipment, food additives, cosmetics, animal food and drugs, alcohol content is less than 7% of wine drinks as well as the supervision and inspection of the electronic product; It also includes cosmetics, radiated products, combination products and other electronic products and medical products related to human health and safety. The testing, testing and certification of ionic and non-ionic radiation produced during the use or consumption of products that affect human health and safety programs. According to the regulations, the products must be approved by the FDA for safety before they can be sold on the market. The FDA has the power to inspect manufacturers and prosecute violators. According to the different product scope under supervision, it can be divided into the following major regulatory bodies:
1. Center for food safety and practical nutrition (CFSAN):
The center is the agency's biggest workload department. It is responsible for food safety throughout the United States except for meat, poultry and eggs under the jurisdiction of the United States department of agriculture. Although the United States is one of the safest food supply country in the world, however, every year there are about seventy-six million foodborne disease, three hundred and twenty-five thousand people died as a result of foodborne illness requiring hospitalization, around five thousand people died of foodborne disease. The center for food safety and nutrition is committed to reducing foodborne diseases, promoting food safety and promoting programs such as the promotion and implementation of the HACCP program. The centre's functions include: to ensure the safety of substances and pigments added to food; Ensure the safety of food and ingredients developed through biotechnology; Responsible for management activities in the correct labeling of food (e.g. ingredients, nutritional health claims) and cosmetics; Formulate policies and regulations to manage dietary supplements, infant food formulations and medical food; Ensure the safety of cosmetic ingredients and products, and ensure the correct identification; To supervise and standardize after-sales activities in the food industry; Conduct consumer education and behavior development; Cooperation projects with state and local governments; Coordinate international food standards and safety.
2. Drug evaluation and research center (CDER):
The center is designed to ensure safe and effective prescription and over-the-counter drugs, in front of the drugs listed on the assessment, and supervise the market sales of more than ten thousand kinds of drugs to ensure that products meet the highest standards constantly updated. It also regulates the authenticity of advertisements for medicines in television, radio and publications. Strictly regulate drugs and provide consumers with accurate and safe information.
3. Equipment safety and radiation protection health center (CDRH):
The center is ensuring the safety and effectiveness of new medical devices. More than 20,000 companies around the world make more than 80, 000 types of medical devices, from blood sugar monitors to artificial heart valves. These products are closely related to people's lives, so the center also oversees after-sales services across the country. The center has also set safety standards for products such as microwave ovens, television sets and mobile phones that produce radiation.
4. Biological products evaluation and research center (CBER):
The center regulation that can prevent and treat diseases of biological products, therefore more complex than chemical synthetic drug, it includes the blood, plasma, vaccine safety and effectiveness of scientific research, etc.
5. Veterinary medicine center (CVM):
Under the anti-terrorism law passed by the U.S. congress in 2003, food companies outside the U.S. must register with the FDA before exporting to the U.S. and notify the FDA of shipments when exporting.
The following foreign food producers and processors must be registered with the FDA under the U.S. public law 107-188:
1. Alcohol and alcoholic beverages;
2. Infant and child food;
3. Bread and pastry;
4. Drinks;
5. Sweets (including chewing gum);
6. Cereal and ready-to-eat cereal;
7. Cheese and cheese products;
8. Chocolate and cocoa products;
9. Coffee and tea products;
10. Food coloring;
11. Regular diet food, medical food and meat substitutes;
12. Supplementary food (i.e. domestic health food, vitamin drugs and herbal products);
13. Seasoning;
14. Fish and seafood;
15. Put materials and materials and products directly in contact with food into the food;
16. Food additives and safe ingredients;
17. Food substitution;
18. Fruit and fruit products;
19. Food glue, lactase, pudding and filling;
Ice cream and related food;
21. Imitation dairy products;
Macaroni and noodles;
23. Meat, meat and poultry products;
24. Milk, butter and dry milk products;
25. Meals and marinades, sauces and specialty products;
26. Dried fruits and nuts;
27. Eggs with shells and egg products;
28. Snacks (flour, meat and vegetables);
29. Pepper, special taste and salt, etc.;
30. Soup;
31. Soft drinks and canned water;
32. Vegetables and vegetable products;
33. Vegetable oil (including olive oil);
34. Vegetable protein products (square meat food);
35. Whole wheat food and flour processed food, starch, etc.;
36. Products mainly or wholly for human consumption;

Contact Details
Shenzhen ZKT Technology Co., Ltd.

Contact Person: Miss. Lydia Liu

Tel: 86--15099904126

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