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?
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?