Australian TGA Guidance on Medical Device Application Audit Process

"The Therapeutic Goods Administration (TGA) provides guidance on the audit process for medical device (including IVD) applications to the Australian Register of Therapeutic Goods (ARTG). Audits ensure compliance with legislative requirements and apply to both mandatory (fee-based) and non-mandatory (fee-free) cases.

Key Points:

Preliminary Assessment: Completed within 20 working days; applications may proceed directly to ARTG or to audit.

Audit Types:
Level 1: Documentation-focused, 50 working days.
Level 2: In-depth specialist review (all IVDs fall here), 150–180 working days depending on audit type.

Audit Management: Sponsors are assigned a case manager for communication and coordination.

Advisory Committee: The ACMD may be consulted for expert input; sponsors can comment before meetings.

Outcomes: Applications are approved if compliant. Deficiencies trigger information requests, while serious non-compliance may lead to refusal or withdrawal."