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Medical Devices / Regulatory Affairs

Devicemakers Support TGA’s Approach to Beefing Up Sanctions and Penalties

Nov. 9, 2017

Devicemakers were mostly supportive of the Therapeutic Goods Administration’s plan to  strengthen sanctions and penalties in Australia so it could respond better to repeated non-compliance.

The agency asked for comments on its proposals to strengthen post-market regulations and to deter misleading advertising of devices and diagnostics by imposing graduated penalties. The consultation was part of a broader review of Australia’s device regulations that began in 2015.

The Medical Technology Association of Australia (MTAA) said in its comments that it supports the proposed three-tiered system of graduated penalties that would impose strict liability and civil penalties for non-compliant advertising.

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