Dot mole pen belongs to medical device products according to its expected function. In the United States, all medical device products are regulated by the US Food and Drug Administration (FDA). The FDA requires all enterprises engaged in the production, processing, packaging and sales of medical devices to be registered with the FDA and obtain a valid registration number; At the same time, the products need to be listed in the FDA and obtain a valid listing number before they can be exported to the United States. In addition, when registering, non-American medical device companies must also designate an agent with an address in the United States to communicate and contact with the FDA on their behalf. The following are the relevant requirements of the annex Amazon for merchants selling medical devices:/gp/help/external/200164650? Language =zh_CN