Australian Medical Device Regulation during COVID-19: Has the Australian Regulatory Framework for Medical Devices Been Effective during the COVID-19 Pandemic?

Medical device regulation was an important element of Australia's response to COVID-19. Early policy initiatives included expedited assessments of COVID-19 diagnostic tests and enhanced communications and information provision. Emergency exemptions enabled continuity of supply of diagnostic tests and personal protective equipment including face masks, and formed part of contingency planning regarding ventilator capacity. A post-market review of face masks improved the quality of face masks included on the Australian Register of Therapeutic Goods, and prompted broader reforms for low risk (Class I) medical devices. Increased compliance activities and infringement notices focused particularly on importation and advertising issues. Medical device regulatory initiatives effectively aligned with broader public policy objectives and helped achieve crucial collaboration between government and industry. Australia's principles-based regulatory framework adapted well to the challenges of COVID-19.