The TGA and the Iron Mask

In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods.

This of course included face masks which were designated as class 1 medical devices. Whilst sponsors and manufacturers worldwide have been able to capitalize on demand, the Therapeutic Goods Administration has started analyzing more closely the compliance of such goods with relevant regulatory requirements. Compliance issues can result in serious consequences for sponsors and manufacturers.

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