Australia Outlines System for Notified Bodies to Assess Devices, Diagnostics

Australia’s Therapeutic Goods Administration is seeking industry comments on its proposed framework for establishing notified bodies in the country to assess devices and in vitro diagnostics.

The measures are part of the TGA’s regulatory reforms that call for the government to develop measures to increase access for drugs and devices in the country. The proposed regulations will be rolled out over the next two years.

The TGA proposal for devices establishes a framework for designating assessment bodies to issue conformity assessment certifications under Australia’s device regulatory framework. These certificates would only be recognized in Australia. — Tamra Sami