We have a good customer (let's call them ABC) that buys our medical device (software) and rebrands/relabels it for sale as a product with their name on it.
They now want to sell our medical device in Mexico. This would not be an ABC-rebranded or relabeled version of our medical device, but our very own medical device. We currently do not have market authorization to sell medical devices in Mexico. I do not know if ABC has the proper authorization either, but if I had to guess, I would say they do not. On the surface, ABC's proposal seems similar to distributor arrangements/agreements we have with other customers, but the difference is the other customers are not selling to Mexico, or any other places where we do not have market authorization. My questions are:
Can anybody out there offer any insight?
They now want to sell our medical device in Mexico. This would not be an ABC-rebranded or relabeled version of our medical device, but our very own medical device. We currently do not have market authorization to sell medical devices in Mexico. I do not know if ABC has the proper authorization either, but if I had to guess, I would say they do not. On the surface, ABC's proposal seems similar to distributor arrangements/agreements we have with other customers, but the difference is the other customers are not selling to Mexico, or any other places where we do not have market authorization. My questions are:
- where is the registration-responsibility line drawn? In other words, once we sell our medical device to ABC, does our regulatory involvment end at that point and what they do with their purchase is their business?
- is the onus on ABC or us to get the proper medical device registration and approval for Mexico?
- knowing that ABC intends to sell to Mexico after we sell to them, should we even entertain the thought of selling our medical device to them in the first place?
Can anybody out there offer any insight?