With the COVID-19 pandemic no longer declared by the World Health Organisation as a Public Health Emergency of International Concern, we have now closed our post market review of facemasks. At the beginning of the COVID-19 pandemic, we commenced this review of all facemask entries on the Australian Register of Therapeutic Goods (ARTG) to ensure the quality, safety and performance of these medical devices.
Due to the critical need for adequate supply of facemasks during this time, facemasks found to be non-compliant with certain regulatory requirements were managed as Product Defect Alerts rather than removing them from use.
As of 21 August 2023, non-compliant facemasks will be subject to recall actions consistent with our standard, non-pandemic approach.
