Medical Device Regulatory Overview for Australia

The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and Ageing, oversees medical device regulation in Australia. Registering your device with the TGA entails risk-based classification; compliance with quality, safety and performance principles; compliance with regulatory controls for manufacturing processes; listing in the Australian Register of Therapeutic Goods; and post-market vigilance programs.

Devices that have already earned CE certification from European Notified Bodies can more easily substantiate conformity to TGA requirements. Manufacturers must also provide Declarations of Conformity to the Australian Regulations in order to register with the TGA. For a detailed overview of the TGA regulatory process, download our free pathway chart.

Let Emergo help you evaluate the Australian medical device regulatory framework as it applies to your device(s)

Emergo can leverage the expertise of our in-house consultants as well as our global network of industry and regulatory contacts to provide accurate and actionable analysis of medical device markets worldwide, including Australia. Our regulatory strategy service provides the following information about the Australian medical device market:

  • TGA regulatory background
  • Product assessment
  • Device classification
  • In-country representation requirements for Australia
  • Medical device registration requirements
  • Medical device labeling requirements
  • Costs and timeframes
  • Regulatory roadmap to market authorization
  • Post-market surveillance/vigilance requirements

Contact us for more information about our Australia regulatory strategy consulting services.


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