Legal Question in Business Law in Massachusetts
What requirements are there to manufacture compression socks from china and sell it in the US? I found information that compression socks are regarded as a medical device in the US but what about compression socks for running and other sports? If they are considered medical device, what licenses, registrations, customs requirements, and other legal requirements for compression stockings do I need to fulfill to manufacture abroad, import, and sell in the US? Are the requirements complicated or expensive?
1 Answer from Attorneys
If they are considered a medical device they need an approval from the FDA. You are not manufacturing the socks you are importing them to the USA. The cost of getting a FDA approval can be expensive. You also need to make sure the socks do not violate any current US Patents if applicable.
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