Australian TGA Responses to Public Comments on Proposed Medical Device Regulation Reforms

The TGA has published public comments to the discussion paper, Reforms in the Medical Devices Regulatory Framework.

Comment submissions came from a variety of stakeholders with varying interests, including industry, professional organizations, and consumer groups. A summary of the comments submitted can be found on the TGA website.

As would be expected with a complex issue that impacts many different groups in different ways, the sentiments expressed towards the proposed reforms were mixed, ranging from complete support to strong disagreement. Hopefully this will ultimately lead to a balanced final reform that serves the interests of all stakeholders.

On February 28, 2011, the TGA announced upgrades to the interface and search capabilities of the Australian Register of Therapeutic Goods (ARTG) — the database of registered medicines and medical devices in Australia. For those not familiar with the ARTG, it is a public database of all registered medicines and medical devices in Australia (ARTG Listing numbers) offered through the TGA eBusiness Services (eBS). Product records contain information on the product sponsor, manufacturer, GMDN code, and more. Users familiar with the system will notice a few changes to the interface. Among other enhancements, users can now filter the product list to recently added medicines or devices. A full description of enhancements is available from the TGA website.

As previously reported, the TGA reformed IVD regulations in 2010 to align with Global Harmonization Task Force (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. The 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 expectation, 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