Tony Conaghan and Claire Slunecko

COVID-19: regulatory exemptions for face masks & medical devices

Tony Conaghan and Claire Slunecko

27 May 2020

Regulatory Exemptions

In light of the current COVID-19 pandemic, the Therapeutic Goods Administration (TGA), which regulates medicines and medical devices (including items such as face masks), has issued (limited) exemptions in relation to medical devices that are, generally, subject to numerous requirements, including applying for their inclusion in the Australian Register of Therapeutic Goods (the Register) before they can be imported, supplied or advertised in Australia. The exemptions are to remain in force until 31 January 2021.

The exemptions are contained within the:

Generally, in certain circumstances, the exemptions allow manufacturers and/or suppliers of the specified products to be exempt from:

  • the essential principles, relating to the safety and performance characteristics of medical devices;
  • conformity assessment procedure, relating to the application of quality management systems for medical devices, and other requirements imposed on manufacturers;
  • evidencing conformity assessment certificates; and
  • including the products on the Register.

 Which medical devices are exempt and in which circumstances?

Exemption 1 – Face masks and other articles

Generally, non-sterile personal protective equipment (PPE) intended for home, occupational or recreational use do not need to be entered on the Register before they can be supplied. However, PPE will be considered a medical device when it claims to be for therapeutic use, such as to prevent the transmission of disease or micro-organisms, which requires it to be included on the Register before it can be imported or supplied.

The exemption narrowly applies to disposable face masks, disposable gloves, disposable gowns, and protective eye wear, which are designed to be worn by individuals to prevent the transmission of organisms (e.g. COVID-19) where these are imported, export, manufactured or supplied to the Australia Government Department of Health or another Commonwealth agency on its behalf.

In addition, manufacturers and suppliers are required to keep records, and produce on request, documents relating to the “importation, exportation, manufacture and supply” of the relevant goods under the exemption.

Additionally, on 1 May 2020, the TGA announced it was conducting a post-market review of face masks that are entered on the Register, due to concerns that have been raised about the quality and effectiveness of some of these products. Manufacturers and suppliers should take note of this to ensure compliance with the relevant quality and other standards and requirements.

Exemption 2 – Accredited Pathology Laboratories

The medical devices that this exemption applies to are in vitro diagnostic medical devices “used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation” of COVID-19 (Diagnostic Tests). It requires that the medical devices be imported or manufactured on behalf of an accredited pathology laboratory or, imported or manufactured for the supply to an accredited pathology laboratory.

In practice, it allows for the rapid supply of COVID-19 tests to Australian accredited pathology laboratories while the TGA continues to expedite the regulatory assessment process for these medical devices. See the TGA response to coronavirus (COVID-19) here.

Exemption 3 – Ventilators

The exemption for ventilators was introduced to ensure the continued supply of ventilators, with the increasing need for use in treatment of COVID-19, and as already approved devices were not readily available.

The exemptions allows for ventilators to be manufactured domestically (in Australia), in accordance with specified minimum technical requirements. However, and importantly, the ventilators under this exemption must be manufactured for supply to a hospital within Australia.

The ventilators manufactured must meet the specified minimum requirements and manufacturers are required to lodge relevant documentation with the Department of Health. If the ventilator adequately meets the specification, the TGA will provide a notice with permission for the supply to proceed.

Importantly, manufacturing and supplying ventilators under the exemption carries ongoing and additional obligations including reporting, record keeping and testing obligations subject to strict timeframes, as well as allowing authorised TGA personnel to enter and inspect relevant premises.

Liability

Despite the exemptions, manufacturers and suppliers are not immune to liability and other offences, and continue to be subject to other obligations such as in respect of product safety, labelling and advertising. Therefore, for example, if a claim is brought against a manufacturer or supplier for negligence under common law or breaches of the Australian Consumer Law, while the circumstances surrounding the emergency exemption may be taken into account, they do not act as a complete defence to liability or relevant offences.

Key takeaways

  • Exemptions are available for certain PPE (e.g. masks and gowns), Diagnostic Tests and ventilators, to be manufactured and supplied without complying with usual requirements regarding safety, quality and effectiveness or being entered on the Register, subject to certain requirements.
  • However, the exemptions are not a gateway to avoid obligations under the TGA regime, and instead generally act as a temporary measure to fast-track supply of the exempted medical devices for use during COVID-19.
  • Manufacturers and suppliers should note that if a claim or offence arises against them due to malfunction or deterioration of an exempted medical device, negligence or failure to comply with advertising or other laws or regulations, the exemptions may not act as a complete defence to liability or alleged offences.

Legal advice

Importantly, the exemptions operate in very narrow, specific circumstances and goods and activities can be subject to other compliance laws and regulations, including as set out above. Legal advice should be sought prior to seeking to rely on any exemptions or otherwise.

Further information

Should you have any questions, please contact a member of Thomson Geer’s Intellectual Property team for a confidential discussion. 

Authors

Tony Conaghan | Partner | +61 7 3338 7502 | tconaghan@tglaw.com.au

Claire Slunecko | Lawyer | +61 7 3338 7563 | cslunecko@tgaw.com.au

Savini Kumaresan |  Law Graduate | +61 7 3338 7963 | skumaresan@tglaw.com.au