Proposed application audit framework for medical devices

This consultation closed on 4 September 2023.

About this consultation

The Therapeutic Goods Administration (TGA) invited stakeholders to provide feedback on how we select medical device applications for audit and how we conduct these audits. 

This consultation sought feedback on key elements of a proposed application audit framework, including:

• risk factors informing non-mandatory audit selection
• criteria for mandatory audits
• the evidence to be provided with applications to inform audit selection
• limiting the number of substantial assessment rounds
• mechanisms to improve visibility of application audit timeframes, and
• cost recovery measures for non-mandatory audits
• pathways for Class III devices with Medical Device Single Audit Program (MDSAP) certification and US FDA 510(k) approval.

Outcome of the consultation 

We received twenty-six (26) responses to this consultation. We published a summary of the responses, including those individual responses where the respondent consented to publication, on our Consultation Hub. 

Next steps

The consultation responses supported the proposed changes to the criteria for mandatory audits and the proposed MDSAP and US FDA 510(k) pathway. The TGA is seeking government approval to amend the legislation accordingly. 

The TGA is also using the feedback from the consultation to:

• develop detailed guidance on the risk factors we will consider when selecting applications for audit
• do further work to review the evidence we require to be provided with applications to inform audit selection
• improve the way we communicate with applicants about these audits
• improve assessment timeframes for these audits.