In brief

In light of the increased demand for personal protective equipment (PPE) at the height of the COVID-19 pandemic, the Therapeutic Goods Administration (TGA) implemented certain emergency regulatory exemptions for PPE. Since the exemptions ceased in January 2021, the TGA has issued infringement notices and has brought proceedings against one company importing PPE. Manufacturers, suppliers and importers should be conscious of the need to meet the full suite of regulatory requirements for PPE.

Therapeutic use

Under the Therapeutic Goods (Medical Devices – Specified Articles) Instrument 2020 (the Specified Articles Instrument), all PPE, including face masks, gloves and gowns, is considered by the TGA to be a medical device if the labelling, instructions, technical documentation or advertising makes claims as to the product’s therapeutic use, for example, to prevent transmission of a disease. This may include PPE that is non-sterile, and not intended for use by health services. PPE that is not intended for therapeutic use is generally exempt from the requirement to be registered on the Australian Register of Therapeutic Goods (ARTG), as outlined in Item 2A of Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018 (the Excluded Goods Determination).

Face masks

All face masks, sterile or non-sterile, are considered medical devices according to the Specified Articles Instrument, if they are intended by the manufacturer for clinical, surgical or medical use, or to prevent the transmission of disease. The TGA will consider the packaging, labelling, instructions, advertising and potentially the manufacturer’s technical documentation in inferring the intended use of the product.

However, under the Excluded Goods Determination, reusable cloth face masks and single use face masks intended for use by the general public are typically exempt from registration on the ARTG, so long as they are not presented to be, or claimed to be, for use in the prevention of the spread of disease. If suppliers of such face masks do not intend to register their products on the ARTG, they should avoid making claims in labelling or advertising regarding therapeutic use.

Specific claims

The standards required of the manufacture of PPE are determined by a number of elements, including intended purpose and likely users of the device. For example, if a filtering face piece respirator is labelled ‘N95’, the TGA expects that the manufacturer will hold evidence of all certification and filtration testing required of an N95 approved product. Additionally, all suppliers of PPE for therapeutic use should be aware of the TGA risk classification of their device under the Therapeutic Goods (Medical Devices) Regulations 2002, as the regulatory requirements differ between classes. Manufacturers and suppliers should be conscious of the therapeutic claims they make regarding PPE, as this may impact the classification and therefore the applicable regulatory standards.

PPE exemptions

Two emergency exemptions introduced by the TGA in early 2020 to address the urgent demand for PPE ceased on 31 January 2021. Consequently, any medical devices supplied during this period will need to be registered in the ARTG before they may now be supplied in Australia.

The Therapeutic Goods (Medical Devices – Ventilators) (COVID-19 Emergency) Exemption 2020 permitted domestic manufacturers to produce ventilators under less stringent regulatory requirements, so long as they were also supplied to Australian hospitals. Since the ceasing of the exemption, ventilators that do not meet the full technical requirements of manufacture outlined in Therapeutic Goods (Medical Devices) Regulations 2002 may no longer be supplied in Australia. Hospitals that acquired ventilators under the exemption are permitted to make use of them, but should consider their possible limitations.

The Therapeutic Goods (Medical Devices – Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 applied to a number of medical devices, including disposable masks, gloves and gowns, which were not included in the ARTG but were for supply for inclusion in the National Medical Stockpile. This exemption only applied to PPE supplied under contract with the Department of Health. Since the ceasing of the exemption on 31 January 2021, any item of PPE must meet the standards of manufacture in Therapeutic Goods (Medical Devices) Regulations 2002 before it may be imported into or supplied in Australia.

In late September 2021, the TGA brought proceedings in the Federal Court of Australia against Enviro Tech Holdings Pty Limited for allegedly importing half a million face masks which included packaging claims for use in the prevention of transmission of disease. The TGA alleges the masks were not included in the ARTG and were imported without a contract with the Department of Health. The TGA brought the proceedings seeking sanctions and penalties after Enviro Tech Holdings failed to pay the infringement notice.

Key takeaways

While PPE continues to be in high demand, the emergency measures implemented by the TGA ended in January 2021. Manufacturers, suppliers and importers should ensure that they have met the applicable regulatory requirements for PPE based on the claims of therapeutic use they make for the products.