Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2021

Overview

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2021, enacted by Dr Brendan Murphy, the Secretary of the Department of Health, under section 41GS of the Therapeutic Goods Act 1989, addresses the urgent need to swiftly make available relevant medical devices during the COVID-19 emergency to safeguard public health. This exemption provides a temporary relief from specific regulatory requirements for Class 4 in-house IVD medical devices used to detect the presence of, or exposure to, SARS-CoV-2 for the purpose of assessing the suitability of donors. The exemption aims to facilitate the rapid deployment of these devices in accredited pathology laboratories to mitigate the threat posed by the COVID-19 pandemic, while ensuring compliance with certain conditions such as record-keeping and availability of records to the Secretary upon request. The exemption is in effect until 30 June 2022, balancing the need for urgent public health measures with regulatory oversight.

Scope and Application

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2021 applies to the use and supply of certain medical devices, specifically Class 4 in-house IVD medical devices intended for donor screening related to COVID-19. This exemption applies across Australia and is made under the authority of the Therapeutic Goods Act 1989. It exempts these medical devices from specific provisions of the Act, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion in the Register, to facilitate their urgent availability in response to the COVID-19 public health emergency. The exemption is limited to devices manufactured and supplied by accredited pathology laboratories, which must maintain records of such activities and make them available upon request by the Secretary. This exemption is in force from the date of its creation until 30 June 2022 and is subject to specific conditions, including adherence to manufacturing and supply by accredited laboratories and record-keeping requirements.

Key Provisions

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2021I, made by Dr Brendan Murphy, as the delegate of the Minister for Health, exempts certain medical devices from specific provisions of the Therapeutic Goods Act 1989 (the Act) to address the public health threat posed by the COVID-19 emergency. This exemption, which commences on the day after its creation, exempts relevant kinds of medical devices, which are Class 4 in-house in vitro diagnostic (IVD) medical devices intended to detect SARS-CoV-2 for donor screening, from Division 1 of Part 4-2 (essential principles), Division 1 of Part 4-3 (conformity assessment procedures), Part 4-4 (conformity assessment certificates), and Part 4-5 (including medical devices in the Register). These exemptions are designed to facilitate the urgent availability of these devices in Australia. The exemption remains in force until 30 June 2022. The exemption is subject to several conditions. Firstly, the relevant kinds of medical devices must be manufactured or supplied only by an accredited pathology laboratory. Secondly, the laboratory must maintain records of the manufacture and supply of these devices, and these records must be made available to the Secretary upon request. The Therapeutic Goods Act 1989 includes various offences and civil penalty provisions applicable to goods exempt under section 41GS. Breaches of the exemption conditions can result in offences and civil penalties under sections 41MNB and 41MNC, while making misrepresentations can lead to penalties under section 41MND. Additionally, the Act requires entities to provide information to the Secretary (section 41JCA) and allows for the search of premises (section 46A). Regulation 6A.1 and Schedule 3A of the Therapeutic Goods (Medical Devices) Regulations 2002 provide the framework for disposing of unused emergency medical devices as per section 41GY of the Act. Failure to comply with the conditions of the exemption may result in civil penalties under sections 41MNB and 41MNC of the Therapeutic Goods Act 1989, which apply to breaches of the conditions of an exemption. Specifically, section 41MNB imposes a civil penalty for breaches of the conditions of an exemption, while section 41MNC outlines the maximum penalty, which can be significant depending on the nature and extent of the breach. Additionally, section 41MND imposes a civil penalty for making misrepresentations related to the exemption, which can also attract penalties. Compliance with the conditions of the exemption is crucial to avoid these penalties and ensure the continued exemption of relevant medical devices during the COVID-19 emergency.