Importer and US agent needed after FDA clearance?

#1
Hey all, We are a medical software company with products certified in Europe nad some in the USA (for only some of the products). We are looking for other markets, and kind of by accident ran into a possible Taiwanese opportunity. Registration for Taiwan (class II product) is much easier when a product has CE and FDA clearance. Only, we do not plan on exporting to the USA (yet). We do have experience with 510(k) process.

So question, after having a product FDA cleared, do you need to list an importer and US agent? I assume the last one is required, but the first one as well? Or are you only required to list one if you are actually going to sell/advertise in the USA? The importer of our USA-marketed products is not suitable as USA importer for the product we want to market in Taiwan.

Our establishment is already listed, so that is no probelm.

Thanks for your response!
Floor
 
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#3
Hi Floor, and welcome! :bigwave:

As mentioned already (and you appear to be aware), a US Agent is necessary to list and market the device in the US.

But, if you're not intending to sell in the US (but nevertheless have a 510(k)), that is an interesting question - probably one that rarely/never gets asked because why on earth would you go through the trouble of 510(k) if you're not going to sell in the US?!

If it's leverage for the purpose of registration in another country, maybe consider Health Canada approval instead... much simpler to clear a Class II.

To address your initial question, however, I'd say that if you are NOT intending to list and market the device in the US, an Agent is not required.
 
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