The process of FDA certification
The application form of FDA certification
1. FOOD: Refers to the general food, in addition to hygiene inspection, but also need to make nutritional labels. Drinks and canned foods also need to be processed for FCE and SID.
2. HEALTH FOOD:Also known as functional foods, in addition to the ordinary food import standards, but also need to improve the effectiveness of human body function, and need to do nutrition labels.
3. DIETARY SUPPLEMENT:Including amino acids, trace elements, vitamins, minerals and herbs, According to the FDA regulations, it can embody the traditional Chinese medicine and health care products in the drug instructions, packaging and labels, and improve the function of human body and prevent the disease. The FDA certification in the United States has strict requirements for the description of components, the packaging and labels.
4. OTC:There is no need for new drug proof, but sufficient material is needed, the effective ingredient is determined in accordance with the regulations. After reaching the FDA requirements for non prescription drugs and obtaining the US Drug Import Registration number (NDC), they can be sold in the U. S. market by drugs.
5. COSMETIC:Refers to the cleaning, pouring and spraying, import or other means for the human body and any parts, in order to achieve clean, health care, landscaping, and treatment or change the appearance effects.
6. Chinese herbal medicine for external use: Consisting of pure natural plants or extracts, use an external dosage form, such as a patch, lotion, suppository, etc. to act on the human body, to play a role in health care.
7. GMP certification: if the Domestic medicine for Western Medicine wants to be legal access to the American market. They must apply to the United States FDA certification and GMP certification. American GMP certification is also the product passport to the international market, and needs to go through two stages:
a. Compiling DMF (DRUGMASTERFILE) and reporting to the United States FDA, and obtaining the DMF registration number.
b. The FDA officials in the United States do the field inspection and certification.