Contact us for TGA registration of surgical masks or N95 respirators, click here for further details.
We can help Australian Sponsors wishing to register surgical masks or medical respirators with the TGA as well as other devices such as thermometers.
Information for health professionals
The demand for surgical masks, surgical and isolation gowns, and surgical suits may overtake the supply available to healthcare organisations during the COVID-19 pandemic. In response to this increased demand, the Department of Health, Office of Health Protection (OHP) and the Therapeutic Goods Administration (TGA) has prepared information to assist healthcare organisations as they update their operating procedures during the outbreak.
Non-medical protective equipment such as 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”. In such case, suppliers should remove any medical claims such as “surgical, medical or clinical” for masks/gowns and then the masks/gowns do not require TGA registration.
Please refer to TGA website here for full details.