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Hello,
I am working at Class 2 medical device manufacturing company.
I'm concerned with countries like Brazil and Russia where device registration is linked to that specific device sales right.
Currently in Brazil, I have a local agent which is not a consulting company and they sell medical device themselves too.. anyhow they also serve as our distributor.
We are in progress for achieving ANVISA and I understand that if our company and our agent (also distributor) obtain certification, our agent/distributor has the right to sell regarding that certification.
So here is my question:
Can I proceed with a different independent agent to obtain new certification from ANVISA with same device (and same model name) and also sell through a different sales path other than my existing agent/distributor?
+please also explain about the sales right issue in Russia if anyone have information.
I apologize in advance if there was any existing thread regarding this issue.
I tried to read through some threads but I couldn't find any..

I am working at Class 2 medical device manufacturing company.
I'm concerned with countries like Brazil and Russia where device registration is linked to that specific device sales right.
Currently in Brazil, I have a local agent which is not a consulting company and they sell medical device themselves too.. anyhow they also serve as our distributor.
We are in progress for achieving ANVISA and I understand that if our company and our agent (also distributor) obtain certification, our agent/distributor has the right to sell regarding that certification.
So here is my question:
Can I proceed with a different independent agent to obtain new certification from ANVISA with same device (and same model name) and also sell through a different sales path other than my existing agent/distributor?
+please also explain about the sales right issue in Russia if anyone have information.
I apologize in advance if there was any existing thread regarding this issue.
I tried to read through some threads but I couldn't find any..
