Dear Reader

We accidentally added an older change history in our previous email. Therefore please see below the correct changes between version 007 and 008 of the new MDSAP Audit Approach document. Sorry for the confusion and thank you very much for your understanding.

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Freshly updated MDSAP Audit Approach document - MDSAP-AU-P0002.008:

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​Changes from version 007 to 008:

Audit Sequence:

• Added the option to audit the Production and Service Controls process following the Measurement, Analysis and Improvement followed by the Design and Development process as a reasonable deviation from the MDSAP audit sequence on page 9

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Management Process:

Task 10

• added clarification that AOs should also consider private-labelled medical devices when verifying that products that have received marketing authorization are imported or sold in Canada.

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Measurement, Analysis, and Improvement Process:

Task 6

• added Canadian regulatory reference.

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Medical Device Adverse Events and Advisory Notices Reporting

Task 1

• removed hyperlinks to Canadian guidance documents.

Task 2

• Correct hyperlink to webpage for TGA Recalls

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Design and Development Process:

Task 10

• Removed the Australian specific requirement. Standards that are used to demonstrate compliance with the Australian Essential Principles are not mandatory. Production and Service Controls

Task 24

• Removed the phrase “as per ISTA 2A”

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Annex 1

• Removed a reference to an Essential Principles Checklist (See Annex 1 - Additional country specific requirements, Australia – TGA, Auditing Technical Documentation, for a description of the use of an Essential Principles Checklist)

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​Link to document​
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Your Regulatory Globe Team

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