TGA Consultation: Medical Device Audit Framework

The Therapeutic Goods Administration (TGA) has announced a public consultation on two draft guidance documents as part of its new risk-based application audit framework for medical devices.

Draft Guidance Documents for Review

• • Selection Criteria for Non-Mandatory Application Audits
    This document provides an outline and clarification of the selection criteria that influence when medical device applications are chosen for a non-mandatory application audit. It also explains the rationale behind the proposed criteria.
  • Medical Device Application Audits: Case Management Process
    This document details the case management model to be applied throughout the lifecycle of an application audit. It includes information on the process, timeframes, and the role of the case manager.

Invitation for Feedback

The TGA invites stakeholders to provide feedback on these draft guidance documents. Your input is valuable and will help shape the implementation of this framework. Feedback is open until 17 February 2025.

Read the full announcement here.

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