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Apply For FDA Certification

　
The U.S. Food and Drug Administration (FDA) is an executive agency under the Department of Health and Human Services (DHHS) and the Public Health Service (PHS). As a scientific regulatory agency, the FDA ensures the safety of food, cosmetics, pharmaceuticals, biological products, medical devices, and radiological products produced in or imported into the United States. It is one of the earliest federal agencies established to protect consumer safety. FDA- certified products, including food, drugs, cosmetics, and medical devices, are deemed safe and effective for human use. In nearly 100 countries, including the United States, only FDA- approved materials, devices, and technologies can be used in commercial clinical applications.

A. Scope of Products Application
1. Traditional Chinese medicine, dietary supplements, medical devices
2. Food
3. Cosmetics
4. Paints and coating products

B. Required Information
1. Chinese manufacturers are required to provide a Business License, Production permit, and Product testing report.
2. Complete product packaging must be submitted.
3. Chinese-language packaging and labeling designs must be provided.
4. Provide semi-finished products, raw materials, and standards, meeting the minimum production batch quantities required by the factory.

C. FDA Registration in the United States
ATDC facilitates the following registration processes:
1. Register Chinese manufacturer
2. Register an American company
3. Conduct product registration

D. FDA Certification Process
1. Register the company and trademark in the United State.
2. Chinese manufacturer provides Chinese-language packaging content, the U.S. partner designs FDA-compliant English labels for Chinese printing.
3. The Chinese side sends raw materials and packaging to the U.S. processing facility to manufacture a specified quantity of finished products.
4. The U.S. partner issues FDA-recognized production license, sales licenses, product testing reports, and a certificate of origin.