Substantial Change in MDSAP Audit

Chrisx

Involved In Discussions
#1
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
 
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Sidney Vianna

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#2
The decision to exit a market that is participatory of the MDSAP Program affects the scope of the audit, so, yes, the Auditing Organization should have been made aware of the change.

Have a look at Q#16 of the MDSAP FAQ Document:

16. What is the best way to determine what is expected of the Auditing Organizations with regard to multiple jurisdictions?

Medical device manufacturers will have to be audited according to the scope declared in their application for certification services. Based on the countries where the manufacturer sells (or intends to sell) or has devices registered, the AO will determine the regulatory requirements applicable to that manufacturer.
The AOs will have to refer to the Audit Model MDSAP AU P0002 and Audit Model Companion MDSAP AU G0002.1 to make that determination. The two documents incorporate or reference the regulatory requirements of each of the participating Regulatory Authorities.
 
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