Brazil - Product Code (and brand) Change

#1
Hi all,

Our company have recently bought another company that make an identical device that they have registered and that they sell in Brazil.

We are now trying to switch all of the 'purchased company' distributors and registrations to the 'new company' device and I'm wondering if it's just a simple 'update' to ANVISA or if we need to start a new registration with the 'new' device?

We have performance studies stating equivalence of the two products, but they have different product codes and different branding.

My initial thoughts are that we will need to start a new registration as ANVISA (and other authorities) will see the two products, with different codes and branding as different products.

Any help and insight is appreciated.

Thanks!
 
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#2
Hi,
You will probably have to place an order to change the registration (depends on the product's risk rating).
If ANVISA requests it, in this process of analyzing changes it would make a requirement asking for a change of ownership.
I don't know about risk classification and company size, because it changes the fees that are paid here a lot.

Best Regards,
 
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