Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023

Overview

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023, made under section 41GS of the Therapeutic Goods Act 1989, was enacted to address the urgent need for medical devices to be made available in Australia during the COVID-19 emergency. This instrument, dated 15 March 2023, provides an exemption from certain regulatory requirements to ensure the swift deployment of Class 4 in-house IVD medical devices intended for detecting SARS-CoV-2 in potential donors. The exemption is subject to conditions including that the devices must be manufactured or supplied only by an accredited pathology laboratory, and that these laboratories must maintain records of such activities and make them available to the Secretary upon request. This legislative measure was introduced to mitigate the threat to public health posed by the COVID-19 emergency, allowing for the rapid assessment of donor suitability while maintaining oversight and compliance through the stipulated conditions.

Scope and Application

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023 applies to certain Class 4 in-house in vitro diagnostic (IVD) medical devices intended for donor screening in the context of the COVID-19 pandemic. This exemption is specifically designed to facilitate the urgent availability of these medical devices in Australia to address the public health threat posed by COVID-19. The exemption applies to devices that are intended to detect the presence of, or exposure to, SARS-CoV-2 for the purpose of assessing the suitability of individuals for the donation of blood, blood components, blood products, cells, tissues, organs, or any derivatives thereof for transfusion or transplantation. The exemption is in effect from the date of its making, 15 March 2023, and will remain in force until 30 June 2024. It exempts these medical devices from various regulatory requirements, including essential principles, conformity assessment procedures, conformity assessment certificates, and the inclusion of medical devices in the Register, under the Therapeutic Goods Act 1989. The exemption is contingent upon the devices being manufactured or supplied only by accredited pathology laboratories, which must maintain records of such activities and make these records available to the Secretary upon request. Failure to comply with the conditions of the exemption may result in offences or civil penalties under the Act.

Key Provisions

The Therapeutic Goods (Medical Devices—Donor Screening) (COVID-19 Emergency) Exemption 2023 (paragraph 1) was made by Brendan Murphy, as delegate of the Minister for Health and Aged Care, and commenced on 15 March 2023. This exemption, which remains in effect until 30 June 2024, provides relief from specific regulatory requirements for certain medical devices under the Therapeutic Goods Act 1989 (paragraph 5(2)). These requirements include the essential principles in Division 1 of Part 4-2, conformity assessment procedures in Division 1 of Part 4-3, conformity assessment certificates in Part 4-4, and the inclusion of these devices in the Register in Part 4-5. The exemption applies to Class 4 in-house IVD medical devices intended to detect the presence of, or exposure to, SARS-CoV-2 for the purpose of assessing the suitability of a person for donating blood, blood components, blood products, cells, tissues or organs, or any other derivatives of these products, of human origin for transfusion or transplantation (paragraph 5(1)). The exemption is contingent upon specific conditions being met (paragraph 6). First, these devices must be manufactured or supplied only by an accredited pathology laboratory (paragraph 6(a)). Second, the laboratory must maintain records pertaining to the manufacture and supply of these devices (paragraph 6(b)). Third, upon request from the Secretary, the laboratory must make these records available for inspection (paragraph 6(c)). Failure to comply with these conditions may result in criminal or civil penalties, as outlined in sections 41MNB and 41MNC of the Act. Additionally, making misrepresentations about medical devices may contravene a civil penalty provision as per section 41MND of the Act. Other provisions in the Act, such as the requirement to provide information to the Secretary (section 41JCA) and the provision enabling search of premises (section 46A), also apply to medical devices exempt under section 41GS. Breach of any condition specified in the exemption may result in significant consequences. Under section 41MNB of the Act, a person may be found guilty of an offence and face criminal penalties. Similarly, under section 41MNC, a person may contravene a civil penalty provision, leading to civil penalties. Furthermore, section 41MND stipulates that making misrepresentations about medical devices may also result in civil penalties. The Act includes other provisions, such as section 41JCA (requiring information provision to the Secretary) and section 46A (enabling search of premises), which are applicable to medical devices exempt under section 41GS. Additionally, Regulation 6A.1 and Schedule 3A of the Regulations detail arrangements for the disposal of unused emergency medical devices for the purposes of section 41GY of the Act.