C
Compliance Officer
Re GMP
I think I have confused us both here, we were told our class IIa devices were exempt from GMP, however we did have to have a one day site inspection at our manf facility to inspect the device we intended to register in Brazil, this had to be done by an approved ANVISA company, rather than sending one of our devices to Brazil for testing
does that make sense?
thanks
I think I have confused us both here, we were told our class IIa devices were exempt from GMP, however we did have to have a one day site inspection at our manf facility to inspect the device we intended to register in Brazil, this had to be done by an approved ANVISA company, rather than sending one of our devices to Brazil for testing
does that make sense?
thanks