All products want to export to the United States, to give you a trick: FDA certification 6 must-have information on the whole strategy!

This is unbelievable! Many Taiwanese cross-border sellers do not know that products exported to the United States must be certified by the FDA! 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 administration of the highest law enforcement agency.

According to Wikipedia, the FDA's main function is to oversee and manage items manufactured 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 brands that want to expand into the US market, understanding the FDA certification process is an essential part of the process!

Did you know that the FDA regulates five major categories of products?

• 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 operators 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.

You'd never guess that the 6 major pieces of information needed to apply for FDA approval include:

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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# Cross-border E-commerce #DA Certification # Taiwan Manufacturers # US Exports # D&B Coding # Global Store Opening # Cross-border Overseas # Amazon Global Store Opening # E-commerce Entrepreneurs # International Brands