Medical Device Regulatory Overview for Australia

The Therapeutic Goods Administration (TGA), a unit of the Australian government’s Department of Health and Aging, 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 EC 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.

Let Emergo Group assist you in evaluating the Australian medical device regulatory framework as it applies to your device(s)

Emergo Group 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 Global Regulatory Overview Report service provides the following information on 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

If you would like to see what these reports include, you can download a sample Regulatory Overview Report.

Please contact us for more information or a free proposal about our Regulatory Overview Report for Australia.