Cross-border sellers must see! U.S. FDA certification full strategy: 6 must-have application information is not hidden to share!

You would never guess that many Taiwanese cross-border sellers have had millions of dollars worth of goods intercepted by U.S. Customs because of an FDA certification issue! The so-called FDA, the U.S. Food and Drug Administration, is authorized by the U.S. federal government, responsible for food and drug management of the highest law enforcement agency.

According to Wikipedia, the FDA's main function is to oversee and regulate products manufactured in and imported into the U.S. These products must be inspected by the FDA and certified as safe before they can be sold in the U.S. market. What does this mean for Taiwanese manufacturers?

What's even more outrageous is that many e-commerce entrepreneurs don't realize that FDA approval covers five major areas: food and dietary supplements, drugs (including veterinary drugs), vaccines and biopharmaceuticals, medical devices and radioactive equipment, and cosmetics and personal care products. Each category has a different responsible agency and area of regulatory responsibility!

Now, the FDA certification application process can be roughly divided into two options: the first is FDA testing, commonly found in materials that will come into contact with food and drugs; the second is FDA registration, which applies to food, drugs, medical devices, cosmetics and other products. What makes people fall through the mirror is that the process of applying for FDA certification contains five major steps: confirmation of product items, preparation of application documents, submission of application information, review and feedback, and finally approval or rejection of the application.

For cross-border e-commerce sellers who want to enter the U.S. market, there are 6 major information that must be prepared to apply for FDA certification:

1. Enterprise business license issued by the competent authority
2. Corporate profile (including date of establishment, asset status, etc.)
3. FDA Registration Application Form (one copy in English and one copy in Chinese)
4. D&B Duns number enterprise authentication code
5. Proof of qualification or production license within the validity period.
6. Product information, clinical trial information, etc. required for certification.

Did you know? Starting in late 2020, the D&B Global Code (D-U-N-S® Number) will be required for FDA applications! This is a unique nine-digit identification number, equivalent to a company's global ID card, that the FDA will use to validate company information and ensure that it is registered with Dun & Bradstreet, so that when an adverse event occurs with a medical device, the supply chain can be quickly determined to protect the consumer's rights.

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