Questions

What is the process of selling products internationally?

My products are detained at US customs. Looks like I need to register products as medical device with FDA. Looking for help on the process and requirements

1answers

The answer to this question depends on the nature of your product, and what 'class' of medical device it would fall under. Depending on what class it is, the process could be as easy as filling out a simple form and sending it to the FDA, or it could be as hard as a multi-year multi-million dollar process involving clinical testing in hospitals. In either case, I'd be happy to map out the process for you.

Feel free to send over more background info and I'll look it over.

best,

Lee


Answered 2 years ago

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