F
Floortje
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
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