Verify the Organization has Performed the Appropriate Activities

The purpose of auditing the Device Marketing Authorization and Facility Registration process is to verify that the organization has performed the appropriate activities regarding device marketing authorization and facility registration with regulatory authorities participating in the MDSAP.

Objective Evidence

As a result of the audit of the Device Marketing Authorization and Facility Registration process, objective evidence will show whether the organization has:

• Complied with requirements to register and/or license device facilities
• Submitted device listing information to regulatory authorities when applicable
• Obtained device marketing authorization in the appropriate jurisdictions
• Arranged for assessment of changes (where applicable) and obtained marketing authorization for changes to devices or the quality management system which require amendment to existing marketing authorization

Links to other processes include:

• Management
• Design and Development

Now, let’s discuss the individual audit tasks related to the Device Marketing Authorization and Facility Registration process.