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:
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
