80%'s cross-border seller gets the first step wrong in getting FDA clearance!

Did you know? The U.S. FDA is closely related to the lives of every U.S. citizen, and is internationally recognized as one of the largest food and drug regulatory agencies in the world. For many Amazon sellers, "FDA certification" may not be unfamiliar, because certain categories are mandated to provide relevant FDA test reports and FDA registration numbers when they are listed on the Amazon platform.

Can you believe that the FDA has two main components, testing and registration, rather than a single certification? Medical devices, cosmetics, food, and pharmaceutical products require FDA registration, and FDA registration can be applied for directly on the official FDA website. For example, the latest regulations in 2025, in general, in order to speed up the progress of registration, you can contact a third-party testing organization such as Green Circle E-commerce to assist in the registration, one-stop solution to the registration audit does not pass the problem of prolonging the registration cycle.

The scope of the Food and Drug Administration (FDA) is much broader than we think: the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; it also includes cosmetics, products with radiation, combination products, and other electronic products and medical products related to personal health and safety. It also includes cosmetic products, products with radiation, combination products and other electronic products related to personal health and safety and medical products.

The biggest problem is that what we often refer to as FDA clearance usually consists of the following categories:

1. FDA Testing of Food Contact Materials
2. FDA Registration of Laser Products
3. Medical Device FDA Registration
4. Cosmetics and Household Products FDA Inspection Reports
5. FDA Registration for Food, Drugs, Cosmetics and Household Goods

If you want to do can contact the agent to do FDA certification, the process is as follows:

1. Provide product information and determine the application path.
2. Fill out the FDA application form
3. Sign the contract and pay the agency fee
4. Payment of US Dollars to the US FDA
5. Submit registration application information to FDA for approval.
6. Registration Approval Completed, Approval Number Obtained
7. Issuance of Certificate of Registration
8. Duration 2 weeks or so

I've noticed that many cross-border e-commerce sellers don't realize that Chinese applicants must designate a U.S. agency as their agent for FDA registration! The agent is responsible for conducting the process in the US and is the link between the FDA and the applicant. In addition, the FDA does not issue product certificates of any nature, the so-called FDA certification seen on the market is the agency's own service certificate issued by the company to facilitate the use of corporate customs clearance.

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# Cross-border E-commerce # Amazon Sellers # DA Certification # Taiwan Manufacturers # Cross-border Exporters # U.S. Market # Product Compliance