Audits FAQs

Responses to commonly asked questions related to MDSAP Audits.

What is the expectation for Class I medical device manufacturers participating in the MDSAP?

Information on the activities/processes, products or facilities that are eligible for exclusion from the MDSAP.

What constitutes a counterfeit medical device or a fraudulent activity requiring notification of RAs?

Definitions for counterfeit medical device and fraudulent activity requiring RA notification.

Can the manufacturer exclude a jurisdiction or products from the scope of an MDSAP audit?

Information on the exclusion of a jurisdiction or products from the MDSAP audit scope.

How long can an MDSAP certificate reference a jurisdiction where no product is distributed?

Information on the period to reference a jurisdiction where no product is distributed.

What are the requirements for the transfer of certification for participating manufacturers?

Information on transfer guidelines and other resources

Do audit tasks have to be repeated during a multi-site audit?

Information on audit tasks undertaken during multi-site audits.

Why have the MDSAP RAs imposed an initial response period of 15 calendar days?

Information on the requirement for an initial response period.

Under what circumstances would an MDSAP audit be followed by an RA inspection?

Information on when an RA inspection may be required.