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TGA Issues Guidance on Face Masks

If there is one thing the Covid pandemic has proved is that there are an enormous variety of face mask options available to the public.

We’ve seen everything from full respirator head masks to medical grade N95 and P2 respirators, to single use surgical masks, to reusable cloth masks to DIY bandanna style face coverings.


At the height of the pandemic supplies were very tight and people were forced to grab any style face mask they could lay their hands on.


Thankfully the panic has subsided, and authorities have been able to issue guidance to allow us all to make better informed decisions.


In January 2021 the Therapeutic Goods Administration issued an update to clarify the requirements for a face mask to be classified as a medical device, capable of preventing the spread of diseases between people. These masks must be registered in the ARTG before being imported into or supplied in Australia. See https://www.tga.gov.au/face-masks-and-respirators-are-regulated-tga for the full report.


As of 1 July 2021, the Protek Nano masks are not registered with TGA and have not been issued with an ARTG number. Once production has been commissioned in our Western Australian factory, we will apply for ARTG registration.

Watch for more updates!


News
01 June 2021

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