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:
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
The TGA has published public comments to the discussion paper, Reforms in the Medical Devices Reg
The Therapeutic Goods (Medical Devices) Amendment Regulations 2010 and the Therapeutic Goods Amendment Regulations 2010 were issued on 25 February 2010. The changes will be implemented on 1 July 2010, and serve to amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The major changes to TGA legislation pertain to the currently largely unregulated in-vitro diagnostic devices (IVDs); the likely implications of which are described below.