Mexico Medical Device Importing and Servicing

fcowdery

Starting to get Involved
#1
We have recently become aware of a US based customer who has sold one our devices to a practice in Mexico however the device is not currently registered in Mexico.

The Device has been cleared by the FDA as Class II.

The customer in Mexico is requesting we provide service for the device.

My question is: Are we able to provide service for the device in Mexico, even though the device has not been registered through COFEPRIS?
 
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apuigvert

Involved In Discussions
#2
Are you sure if the device requires registration in Mexico? maybe you should first check the list of products exempt of registration.
 
#3
Hi fcowdery,

I think the best approach is to find out from the customer in Mexico, the conditions under which the device was imported (personal use, research, etc.).
This will help determine your liability and whether or not you are obligated to service the device.

Keep in mind that if the device is used in a medical setting (outside of research or personal use) without a registration, there could be serious consequences for your client.

Post your findings and I will be happy to help.
 
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