What is US FDA?
The U.S. Food and Drug Administration (FDA) is a federal agency under the Department of Health and Human Services that protects and promotes public health by regulating food safety, dietary supplements, prescription and over-the-counter drugs, vaccines, biopharmaceuticals, medical devices, cosmetics, animal food and feed, and more. Its primary role is enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) among other laws. Companies exporting food, cosmetics, and medical devices to the US typically need to complete FDA registration/listing as baseline compliance.
SINOQUAL's FDA service
SINOQUAL provides US FDA establishment registration, product listing, and regulatory consulting, and can deliver it together with certifications such as Kosher, helping Chinese companies meet the baseline compliance to export to the US.
The process
1. Free assessment: confirm product category and target compliance scope. 2. Prepare company and product information. 3. Complete FDA registration / product listing. 4. Label and regulatory conformity check. 5. Deliver registration details and compliance recommendations.
FAQ
- Which products need FDA registration?
- Food, dietary supplements, cosmetics, and medical devices exporting to the US typically need FDA registration or listing. The specifics depend on the product category and the latest US regulations — call 400-001-7706.
- How long does it take?
- It depends on the product category, ingredient complexity, system readiness, and the body's scheduling. After a free assessment we back-schedule to your delivery dates. For specifics, call 400-001-7706.
- How much does it cost?
- Fees vary by category, ingredient complexity, and audit scope, and change with the body's policy. To avoid outdated quotes, we provide one-on-one precise estimates — call 400-001-7706.
- What materials do we need to prepare?
- Typically the business license, product ingredients/process flow, and related qualification documents; we provide the full checklist and help with translation, packaging, and filing — you only sign/stamp and support the on-site audit.