Consultation: Draft guidance documents on the medical device audit framework

While the consultation is open you can make a submission at our TGA consultation hub- external site. We then review the submissions. After that the submissions and our decision will be available on the same page at the TGA consultation hub- external site.

About this consultation

We are seeking feedback on two new guidance documents developed as part of the proposed new risk-based application audit framework:

1. Draft Guidance - Selection criteria for non-mandatory application audits.

This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria. 

2. Draft Guidance - Medical device application audits: Case management process.

This guidance document outlines the case management model that will be used throughout the life cycle of an application audit. It details the process, timeframes, and the role of the TGA case manager.

All recent TGA consultations can be found at the TGA consultation hub- external site.