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Medical Devices / Regulatory Affairs

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

Nov. 9, 2017
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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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