Importation of Face Masks and Sanitisers (Australia)

Please refer below and links to the processors and protocols and the differences between TGA requirements and general everyday antibacterial products. All products that claim to be VIRUS grade require TGA approval.

"Face masks and gowns which are non-sterile and designed as safety or protective apparel for use in the home or for recreational or occupational use (for example, nursing) are excluded from regulation by the TGA under the Act."

Face masks and gowns which are presented or claimed to be for therapeutic use, such as being labelled for surgical use, or to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, meet the definition of a medical device and are regulated by the TGA under the Act.

If these masks or gowns are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.

That literally covers all of the masks being imported into Australia right now. Any mask that's being declared as "not for therapeutic use" for importation purposes but then sold to consumers as protection against covid-19 infection would not be following this declaration guideline.

According to the "TGA issues warning about illegal advertising relating to COVID-19" page on TGA website, click HERE

Federal Register of Legislation, click HERE

National Industrial Chemicals Notification and Assessment Scheme click HERE