Three sentences completely solve the FDA certification application problems! Taiwan Sellers Must Read for U.S. Market Exports

Taiwan cross-border sellers who regularly export products to the United States must understand the FDA certification process! The so-called FDA, refers to the U.S. Food and Drug Administration, is authorized by the U.S. federal government, is responsible for food and drug management of the highest law enforcement agencies.

According to Wikipedia, the FDA's main function is to oversee and regulate items manufactured and imported into the U.S. These products must be tested and certified as safe by the FDA before they can be sold on the market. This is important for cross-border exporters who want to enter the U.S. market!

The FDA regulates five major categories:

1. Food and Dietary Supplements: Safe Food Additives and Colors by CFSAN
2. Pharmaceuticals (including veterinary drugs): CDER is responsible for the regulation of new, generic and over-the-counter drugs.
3. Vaccines and biomedical preparations: CBER is responsible for ensuring that vaccines and biologics are safe and effective.
4. Medical Devices and Radiological Equipment: CDRH is responsible for ensuring the safety and effectiveness of medical devices.
5. Cosmetics and personal care products: CFSAN is responsible for ensuring the safety of cosmetic ingredients.

You would never guess that there are two types of FDA certification application programs: FDA Inspection and FDA Registration. FDA Inspection 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.

For Taiwan sellers, 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.

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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