In 2020, heightened demand for health care resulted in an influx of therapeutic goods being included on the Australian Register of Therapeutic Goods (ARTG). A large portion of these goods are manufactured in China however, due to the significant spike in demand from around the world many businesses have modified their usual operations, for example apparel manufacture, to instead manufacture personal protective equipment in order to capitalize on the opportunity. This has been evident across Southeast Asia and in particular Vietnam. Whilst speed of entry onto the ARTG assisted sponsors and manufacturers to capitalize on demand, the Therapeutic Goods Administration (TGA) has now shifted its focus from including therapeutic goods on the ARTG to verifying that these goods comply with relevant regulatory requirements. Notably this has led to a post market review into the efficacy of face masks (class 1 medical devices), and action being taken against sponsors.
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