80%'s cross-border seller gets the first step wrong in getting FDA clearance!

你知道嗎？美國FDA機構與每一位美國公民的生活都息息相關，在國際上被公認為是世界上最大的食品與藥物管理機構之一。對於不少亞馬遜賣家而言，”FDA認證”可能並不陌生，因為某些品類在上架亞馬遜平台時，被強制要求需要提供相關的FDA測試報告和FDA註冊編號。

你相信嗎？FDA主要分測試和註冊兩個內容，而非單一認證。醫療器械、化妝品、食品、藥品類產品需要進行FDA註冊，FDA註冊可以直接在FDA官方網站上進行申請。比如2025年最新規定，一般情況為了加快註冊進度，可以聯繫綠圈圈電商等第三方檢測機構進行協助註冊，一站式解決註冊審核不通過延長註冊週期的問題。

The scope of the Food and Drug Administration (FDA) is much broader than we think: the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, and electronic products; it also includes cosmetics, products with radiation, combination products, and other electronic products and medical products related to personal health and safety. It also includes cosmetic products, products with radiation, combination products and other electronic products related to personal health and safety and medical products.

最大的問題就是，我們常說的FDA認證，通常包含以下種類：

1. FDA Testing of Food Contact Materials
2. FDA Registration of Laser Products
3. Medical Device FDA Registration
4. Cosmetics and Household Products FDA Inspection Reports
5. FDA Registration for Food, Drugs, Cosmetics and Household Goods

如果您想辦理可以聯繫代理辦理FDA認證，辦理流程如下：

1. Provide product information and determine the application path.
2. Fill out the FDA application form
3. Sign the contract and pay the agency fee
4. Payment of US Dollars to the US FDA
5. Submit registration application information to FDA for approval.
6. Registration Approval Completed, Approval Number Obtained
7. Issuance of Certificate of Registration
8. Duration 2 weeks or so

我注意到很多跨境電商賣家不知道，中國申請人在進行FDA註冊時必須指派美國機構作為其代理人！該名代理人負責進行位於美國的過程服務，是聯繫FDA與申請人的媒介。此外，FDA不簽發任何性質的產品證書，市面上見到的所謂FDA認證證書都是代理公司自己簽發的服務證書，方便企業通關使用。

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#跨境電商 #亞馬遜賣家 #FDA認證 #台灣製造商 #跨境出口商 #美國市場 #產品合規