FDA Certification Process
 

FDA Certification application form

 

1, FOOD: refers to ordinary food, in addition to health inspection also need to make nutrition labels. Beverages and canned foods also require FCE (Factory Registration) and SID (Product registration).

 

2, health food (HEALTHFOOD) : also known as functional food, in addition to meeting the import standards of ordinary food, but also need to have the effect of improving human function, but need to do nutrition labeling.

 

3, nutritional supplement (DIETARYSUPPLEMENT) : including amino acids, trace elements, vitamins, minerals and Chinese herbal medicine, according to FDA regulations, it can reflect the role of traditional Chinese medicine, health care products to improve human function and prevent disease on the drug instructions, packaging and labels. The United States FDA certification has strict requirements for the description of the components and the outer packaging and labeling.

 

4, over-the-counter drugs (OTC) : do not need to do new drug demonstration, but need to provide sufficient materials, in accordance with regulations to identify the active ingredients. After meeting the requirements of the FDA for over-the-counter drugs, and obtaining the United States Drug Registration number (NDC), it can be marketed as a drug in the United States market.

 

5. COSMETIC: Any item used on the human body or any part thereof by rubbing, pouring, sprinkling, spraying, introducing or otherwise for the purpose of cleaning, health care, beautification, treatment or changing appearance.

 

6, Chinese herbal medicine for external use: composed of pure natural plants or extracts, external dosage forms such as patches, lotions, suppositories and other forms of action on the human body, play a role in health care and treatment products.

 

7, GMP certification: In order to legally enter the US market, the domestic Western pharmaceutical raw materials must apply for GMP certification to the US FDA certification. The certification of GMP in the United States is also the passport for products to the international market. There are two stages:

 

(1) Prepared DMF (DRUGMASTERFILE) and submitted it to FDA for certification, and obtained DMF registration number.

 

(b) the United States FDA officials field inspection and certification.