The Therapeutic Goods Administration (TGA) has commenced proceedings in the Federal Court against Enviro Tech Holdings Pty Ltd (Enviro Tech), and its executive officers (Connie and Jerry Triantos) for the alleged unlawful importation of surgical face masks.
Under a legal exemption introduced in March 2020 to allow Australia to rapidly respond to the COVID-19 pandemic, certain medical devices, including surgical face masks, were able to be imported without first being includedon the Australian Register of Therapeutic Goods (ARTG).
However, this only applied to medical devices supplied to the National Medical Stockpile under a contract with the Department of Health, which maintains the stockpile.
It is alleged that Enviro Tech imported surgical face masks without the required contract and without including them on the ARTG at the time of import.
As such, the TGA contends that Enviro Tech has not complied with provisions of the Therapeutic Goods Act 1989 (the Act) that are intended to ensure medical devices imported into Australia are safe and perform as intended by the manufacturer.
In December 2020, Enviro Tech was issued with a $13,320 infringement notice for the alleged breach. However, as Enviro Tech did not pay the infringement notice, further legal action is now being taken.