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

太不可思議了！很多台灣跨境賣家不知道，產品出口美國必須通過FDA認證！所謂FDA，指的就是美國食品藥物管理局，是由美國聯邦政府授權，負責食品與藥品管理的最高執法機關。

根據維基百科描述，FDA主要職能是監督管理美國國內生產及進口的相關項目，這些產品必須經過FDA檢驗，證明安全才可在市場上銷售。對於想拓展美國市場的跨境品牌商而言，了解FDA認證流程是必不可少的一環！

你知道嗎？FDA認證主要監管五大類別產品：

• 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.

最大的問題就是，很多電商營運者不清楚FDA認證申請方案可分為兩種：FDA檢測和FDA註冊。FDA檢測常見於接觸食品、藥品的材料；而FDA註冊則適用於食物、藥品、醫療器械、化妝品等產品。

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.

你絕對想不到，申請FDA認證所需的6大資料竟然包括：

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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