While the COVID-19 pandemic has seen some industries crumble, it has also created opportunities for others to thrive. One such industry is the medical device export industry, with burgeoning international demand for Australian manufactured COVID-19-related medical devices such as masks, ventilators and diagnostic testing kits. In this alert, Partner, Luke Mountford provides guidance to would-be exporters of such devices in navigating the changing backdrop of Australia’s therapeutic goods legislation.
Key points
- The export of medical devices is governed by Australia’s therapeutic goods legislation.
- Under the statutory framework, exporters will be criminally responsible for failure to ensure that, prior to exportation, a medical device:
- is included in the Australian Register of Therapeutic Goods;
- complies with the ‘essential principles’ for medical devices; and
- complies with the conformity assessment procedures required to be undertaken for that device.
- Exporters may be able to avoid the need for compliance with these requirements if they can rely on one of several COVID-19-related exemptions granted by the Health Minister.
What is a medical device?
The export of medical devices produced by Australian manufacturers is governed by the Therapeutic Goods Act 1989 (Cth) (Act) and Therapeutic Goods (Medical Devices) Regulations 2002 (Regulations). The Act broadly defines ‘Medical Devices’ to include “an instrument, apparatus, appliance, material or other article which is intended to be used for diagnosing, preventing, monitoring, treating, or alleviating a disease, injury or disability”. Accordingly, COVID-19-related devices such as face masks, respirators, testing kits and ventilators constitute medical devices and are subject to the Act and the Regulations.
What are my obligations as an exporter?
Australia’s therapeutic goods legislation places the most significant burden on manufacturers of medical devices, rather than suppliers or exporters. However, with some exceptions, a person who exports a medical device from Australia must ensure that:
- the device complies with the ‘essential principles’ about the safety and performance characteristics of medical devices (a checklist for assessing these principles can be found here);
- the device is included in the Australian Register of Therapeutic Goods (ARTG) and the exporter is either:
- the person named as the sponsor for that device in the ARTG; or
- exporting the device as an authorised agent acting on behalf of the person named as sponsor for the medical device; and
- the manufacturer of the device has complied with the conformity assessment procedures in accordance with the requirements of the Therapeutic Goods legislation,
(together, the Requirements).
The stringency of the Requirements depends on the ‘classification’ given to a particular medical device, with more invasive devices and those intended for long-term use attracting higher risk classifications. Exporters can minimise the conformity assessment procedures to be complied and hasten the inclusion of a medical device in the ARTG by applying for it to be included as a ‘Class I Medical Device (Export Only)’. Where this occurs, exporters are precluded from supplying the device in the Australian Market.
What happens if I don’t comply with the Requirements?
Exporters should be wary that they may be liable for failing to take sufficient steps to ensure compliance with the Requirements, even if a wholesaler has falsely asserted that products are compliant.
Failure to comply with any of the Requirements constitutes an independent offence under the Act. The maximum penalty associated with each offence is 12 months imprisonment or 1,000 penalty units (or both). Civil penalties may also apply. Further, where a failure to comply with the essential principles is such that the subject medical device may, would or does result in harm to any person, a maximum penalty of five years imprisonment or 4,000 penalty units (or both) applies.
Are there any COVID-19-related exemptions to the Requirements and/or my obligations?
Australia’s Health Minister is empowered to declare certain medical devices exempt from compliance with the Requirements to facilitate the stockpiling or urgent provision of those devices in an emergency. Unsurprisingly, the COVID-19 pandemic has yielded a suite of these exemptions, however only the following are relevant to exporters of medical devices:
- the Therapeutic Goods (Medical Devices – Novel Coronavirus) (Emergency) Exemption 2020 (Diagnostic Device Exemption); and
- the Therapeutic Goods (Medical Devices – Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (Face Mask Exemption).
All other exemptions contemplate the supply of COVID-19-related medical devices to the Australian market.
Both the Diagnostic Device Exemption Face Mask Exemption remain in force until 31 January 2021.
Can I rely on the Diagnostic Device Exemption?
Exporters can rely on the Diagnostic Device Exemption to export medical devices without complying with any of the Requirements if, and only if:
- the medical device being exported is to be used for the diagnosis, confirmatory testing, prevention, monitoring, treatment or alleviation of novel coronavirus (for example, a serology testing kit); and
- the exporter is a laboratory that is a state or territory member of the Public Health Laboratory Network.
Can I rely on the Face Mask Exemption?
Exporters can rely on the Face Mask Exemption to export medical devices without complying with any of the Requirements if, and only if:
- the medical devices are face masks, disposable gloves, disposable gowns, protective eyewear in the form of glasses, goggles or visors designed to be worn to prevent the transmission of organisms; and
- the exporter is exporting those devices under a contract with the Australian Government Department of Health or another agency of the Commonwealth acting on behalf of the Department for that purpose.
What if none of the exemptions apply?
Exporters who are unable to rely on either of the above-mentioned exemptions must ensure compliance with all relevant Requirements prior to exporting any medical devices.
Final notes
The landscape of Australia’s therapeutic goods legislation is rapidly changing in an effort to adapt to the COVID-19 pandemic. For further information or assistance in ensuring your compliance with the Requirements, please contact our Private Enterprise team.