In the United States, selling goods on commercial platforms like Amazon is straightforward for most products — as long as they’re not classified as special items, they can be shipped from Taiwan to the U.S. and sold there.
However, when it comes to medical devices, the process becomes much more complicated. Here, we record the essential requirements.
Assumption:
Planning to list and sell Class I medical device products (e.g., medical masks) on the U.S. Amazon platform.
在美國境內賣東西,像亞馬遜等商業平台,只要不是特殊物品,可由台灣發貨至美國後販售。
但碰上了醫療器材,過程將繁複許多,在此紀錄必須條件
前提設定:
欲將第一級醫材 (e.q.醫用口罩類) 產品上架美國亞馬遜平台販售
條件及相關步驟:
在美國本土設立公司,或是找到合適的美國本土經銷商,做跨境販售據點。
其中開美國公司將牽涉到以下幾點: