What is required to export Class I (non exempt) 510(k) approved product to Mexico

A

Achemd

#1
We have a class I (non exempt) product that is 510(k) approved. Does the FDA have any requirements that we need to address to export to Mexico?
Thank you :thanx:
 
Elsmar Forum Sponsor
A

Achemd

#3
Re: What is required to export to Mexico

Thank you, would the same apply for a Class 1 (exempt)? Thus no 510(k)??
 
R

rcholland

#4
Re: What is required to export to Mexico

The FDA does not have any requirements, it is more of an issue for the Mexican regulations. For Mexico, you need to have someone in country that is registered who will handle everything for you.
 
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