Feb 28, 2011

As previously reported, the TGA reformed IVD regulations in 2010 to align with GHTF recommendations, adopting a risk-based classification system. Under the new system, many IVDs will be subject to more rigorous controls, including random and mandatory audits. TGA has now published multiple IVD guidance documents.

The TGA has most recently issued guidance outlining several key points regarding IVD application audits (Technical File Review), including:

  • general purpose of an audit
  • application audit process 
  • expectations for a Technical File
  • criteria for mandatory audit
  • audit fees
  • documents requested in an audit

This document should be of value to manufacturers and regulatory professionals, both as a means to comply with TGA expectations, and to prepare for and manage a TGA audit. The full text can be found on the TGA website at: https://www.tga.gov.au/publication/application-audit-technical-file-review-ivd-medical-device-applications


  • Stewart Eisenhart