Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020

Overview

The Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 was enacted on 22 March 2020 by Caroline Edwards, acting as the delegate of the Minister for Health, under section 41GS of the Therapeutic Goods Act 1989. This exemption was introduced to address the urgent need for medical devices such as disposable face masks, gloves, gowns, and protective eyewear during the COVID-19 public health emergency, which the World Health Organization declared as a pandemic on 11 March 2020. The primary objective of this exemption is to facilitate the rapid availability of these essential medical devices in Australia to mitigate the threat to public health posed by the COVID-19 outbreak. The exemption exempts relevant medical devices from certain regulatory requirements, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion in the Register, but it remains in effect until 31 January 2021. The exemption is conditional upon the medical devices being supplied under a contract with the Australian Government Department of Health or another Commonwealth agency acting on its behalf, and the supplier must maintain and provide access to records of importation, exportation, manufacture, and supply upon request.

Scope and Application

The Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 applies to the importation, exportation, manufacture, and supply of relevant kinds of medical devices, specifically disposable face masks, disposable gloves, disposable gowns, and protective eye wear designed to prevent the transmission of organisms. The exemption applies nationwide under the jurisdiction of the Commonwealth, as it is made under the Therapeutic Goods Act 1989. It is applicable to any person or entity involved in the specified activities, provided they do so under a contract with the Australian Government Department of Health or another Commonwealth agency acting on behalf of the Department. The exemption is in effect from the date of its making until 31 January 2021 and exempts the specified medical devices from various regulatory requirements, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion of devices in the Register. The exemption is subject to conditions, including the requirement for records to be kept and made available upon request by the Secretary.

Key Provisions

The Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020 (section 5) provides an exemption from several parts of the Therapeutic Goods Act 1989 (section 4) for specific medical devices designed to prevent the transmission of organisms. These devices include disposable face masks, disposable gloves, disposable gowns, and protective eyewear such as goggles, glasses, or visors. The exemption is designed to address the urgent need to make these devices available in Australia to manage the public health threat posed by the COVID-19 emergency. The exemption applies to the essential principles (section 5(1)(a)), conformity assessment procedures (section 5(1)(b)), conformity assessment certificates (section 5(1)(c)), and the inclusion of these devices in the Register (section 5(1)(d)). The exemption is subject to certain conditions (section 6). Firstly, the relevant medical devices can only be imported, exported, manufactured, or supplied by a person under a contract with the Australian Government Department of Health or another Commonwealth agency acting on behalf of the Department of Health (section 6(a)). Secondly, the contracting party must maintain records of the importation, exportation, manufacture, and supply of these devices (section 6(b)). These records must be made available to the Secretary upon request (section 6(c)). The exemption remains in effect until 31 January 2021. Breaches of the conditions outlined in section 6 of the exemption are subject to offences and civil penalty provisions under Division 3A of Part 4-11 of the Therapeutic Goods Act 1989. The specific penalties for non-compliance are not detailed in the exemption instrument itself but can be found in the relevant sections of the Act. Additionally, Regulation 6A.1 and Schedule 3A of the Therapeutic Goods (Medical Devices) Regulations 2002 provide arrangements for the disposal of unused emergency medical devices, which are pertinent to section 41GY of the Act.