Software as Medical Device import activities for Chile and Mexico


Hi All,

We are a company that manufactures SaMD, in particular PACS software.

We are already present in the Chilean and Mexican market but we have initiated an integration project with a company that provides CAD AI software detection for lung and breast cancer. We would like to provide this integration in Chile and Mexico.

My questions are regarding these two countries:
- For Chile: there should not be any registration needed but are there import requirements that the 3rd party company needs to fulfill? Or can we go and sell/distribute directly?
- For Mexico: the company has already a collaboration project in production with another PACS provider and Salud Digna. And no (MD) importer is designated. Does this mean that we could also here go directly into the market and start selling/distributing the integration?

Thanks in advance for your answers!
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