Australia Issues Update on Medical Device Reform

September 11, 2017

Australia’s Therapeutic Goods Administration released a status report on regulatory reforms for medical devices, including upcoming changes.

The reforms will enhance post-market surveillance and “improve the integration of pre- and post-market activities,” the TGA said.

Upcoming reforms for devices include:

  • A single complaint handling function within TGA for advertising compliance;
  • Enhanced sanctions and penalties related to advertising offenses;
  • An expedited pathway for novel medical devices and designation of conformity assessment bodies in Australia to undertake medical device conformity assessment certification;
  • Use of approvals from comparable overseas regulators to support listing on the Australian Register of Therapeutic Goods (ARTG); and
  • Harmonization of medical device regulations to align with the EU medical device regulatory framework, which includes up-classification of surgical mesh from Class IIb to Class III and patient implant identification cards. 

The agency anticipates releasing new guidance this month on enhanced post-marketing compliance monitoring, additional evidence sources for de novo evaluation, use of international evaluation reports, and assessment timeframes and fees.

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