Recent enforcement actions by the Australian Therapeutic Goods Administration (TGA) indicate that the regulator continues to actively monitor and prosecute businesses for breaches of the Therapeutic Goods Act 1989 (TG Act) and the Therapeutic Goods Advertising Code (No. 2) 2018 (TG Advertising Code) related to the ongoing COVID-19 pandemic.

The TGA has recently issued fines, including to:

• A company that did not include its surgical face masks on the Australian Register of Therapeutic Goods (ARTG) at the time of importation, and did not satisfy the condition for its products to be exempted from inclusion on the ARTG under the Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (TG Exemption). Under the TG Act, all medical devices, including face masks, imported into and/or supplied in Australia must be included on the ARTG unless otherwise exempted (e.g., by way of the TG Exemption). In order for the TG Exemption to apply, the person importing the face masks must be party to a contract with the Australian Department of Health (or another agency of the Commonwealth Government acting on behalf of the Department) to supply personal protective equipment, including face masks, to Australia’s National Medical Stockpile. Australia’s National Medical Stockpile is a strategic reserve of drugs, vaccines, antidotes and personal protective equipment purchased by Australian Department of Health for use in national health emergencies. The company was fined $13,320.
  
  
• A company that implied on its website that its COVID-19 testing kit was endorsed by a government authority. The TG Advertising Code stipulates that advertisements for therapeutic goods must not expressly or impliedly suggest that the goods are endorsed by a government authority, such as the TGA. The company was fined $13,320.

Key Points to Note

From these enforcement activities, the key points to note for businesses supplying or advertising medical devices are that:

• all medical devices imported into and/or supplied in Australia must be included on the ARTG unless otherwise exempted by applicable law. Face masks that are claimed to assist in preventing disease transmission between people or are to be used for therapeutic purposes, are considered medical devices;
  
  
• in order for face masks to be exempted from inclusion on the ARTG, certain conditions must be satisfied (such as being imported for supply to the National Medical Stockpile); and
  
  
• advertisements should not expressly or impliedly suggest that any therapeutic goods are endorsed by a government authority (such as the TGA).