We recently exited the Brazilian market. We consulted with ANVISA to inform them of our decision. Now at our MDSAP audit, the auditor is claiming we did not notify the MDSAP Conformity Assessment Body (I guess that's what you call it) of the change. Our procedures for determining substantial change would not identify this as a substantial change. We cannot identify any requirement for this in our contract with the MDSAP CAB. Does anyone have any ideas where the auditor might be identifying this requirement?
Thanks,
ChrisX
Thanks,
ChrisX