How to apply for US FDA certification,American FDA certificate
Brand Name:ZKT
Certification:FDA
Model Number:ZKT
Place of Origin:CHINA
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Shenzhen Guangdong China
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No. H, 2nd Floor, 1st Building, Quanzhi Technology Innovation Park, Shasong Road, Houting, Shajing Street, Bao’an District, Shenzhen, China
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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;
How to apply for US FDA certification,American FDA certificate
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