80% people applying for FDA approval, the first step is wrong! 6 must-have information complete reveal

I really did not think that many Taiwan cross-border sellers in the application for U.S. FDA certification, even from the first step on the wrong! The so-called FDA, refers to 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 items 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 market. For cross-border exporters who want to enter the U.S. market, it is important to understand the FDA certification process!

Do you know what industries are regulated by the FDA? FDA accreditation covers five major areas:

• Food and dietary supplements: CFSAN is responsible for ensuring the safety of food additives
• Pharmaceuticals (including veterinary drugs): CDER is responsible for the regulation of new, generic and over-the-counter drugs.
• Vaccines and biomedical preparations: CBER's responsibility for ensuring the safety of vaccines and biological products
• Medical Devices and Radiological Equipment: CDRH is responsible for ensuring the safety and effectiveness of medical devices.
• Cosmetics and personal care products: CFSAN is responsible for ensuring the safety of cosmetic ingredients.

The biggest problem is that many e-commerce entrepreneurs are not aware that there are two types of FDA certification application programs: FDA testing and FDA registration; FDA testing is commonly used for materials that come into contact with food and pharmaceuticals; while FDA registration applies to food, pharmaceuticals, medical devices, cosmetics, and other products.

The FDA approval process consists of 5 major steps: identification of product items, preparation of application documents, submission of application information, review and feedback, and finally approval or denial of the application. For example, if a medical device is exempted from 510(K), it only needs to be registered and listed, and the application can be completed in about 1~2 weeks after the information is complete.

The most shocking thing is that the 6 major information required to apply for FDA approval includes:

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.

What's even more outrageous is that starting in late 2020, the Dun & Bradstreet Global Number (D-U-N-S® Number) will be required for FDA filings, a unique nine-digit identification number that is equivalent to a company's Global ID! This is a unique nine-digit identification number that is equivalent to a company's "global ID card," and is used by the FDA to validate company information, ensure that it is registered with D&B, and protect consumers by allowing them to quickly determine the supply chain in the event of a product problem.

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