Becoming an In Country Entity in Foreign Countries

S

shasti212

#1
I apologize if this is not in the right spot, first off...

We were posed a question in another department. Some background, our medical device company was bought out by a big name which owns many different types of businesses.

Here is the question: We want to divert away from our distributors in Mexico and Brazil and utilize some of our parent company's offices in those countries. However, these offices are not necessarily medical device companies. Even though they aren't, can we still use their location to establish in country representation for product registrations?

I have been trying to research this for those that asked the country. It appears to me you have to establish certain licenses (I still can't quite pin down those exact licenses) as well as be able to handle recalls and MDR's.

Is there any reason that a non medical company can't handle this pending they receive all proper licenses? What are your experiences in this type of situation?

Thanks for all input!
 
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Ronen E

Problem Solver
Moderator
#2
Hi,

As a general notion, if they comply with all applicable requirements and/or get all required licenses / registrations, they will become "a medical device company" for that matter. I'm not an expert on Mexico or Brazil, but normally the requirement is to have a registered place of business in the country, and compliance with some basic, country-specific, "Good Authorized Representative Practices" requirements.

Cheers,
Ronen.
 
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