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Post-market review of face masks: Cancelled ARTG entries

21 July 2021

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page lists all face masks cancelled from the ARTG during the review. For general information about the review, including guidance for suppliers and users of face masks, see Post-market review of face masks: Overview.

Cancelled face mask ARTG entries

The ARTG entry for a face mask may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. With respect to the ARTG entries voluntarily cancelled by the sponsor, it is important to note that some of these devices may not be subject to a recall action. This is because the TGA may not have received any evidence for those entries about their compliance to any manufacturing standards. The TGA holds no evidence these devices meet appropriate manufacturing standards or failed to perform as intended. The decision to cancel the ARTG entry was made solely by the sponsor.

Upon applying for an ARTG inclusion, the sponsor certifies that they have evidence to support the devices safety and performance and that the device meets the Essential Principles or that the information can be obtained from the manufacturer within a specified timeframe. Therefore, it is expected that the manufacturer holds certain kinds of evidence (such as test reports to a nominated standard) to support the devices performance.

Where a face mask does not meet all the necessary regulatory requirements (e.g. non-conformance with the Essential Principles, failed laboratory testing, etc.) and/or is not performing as intended, consideration of where these masks are being used and if they pose an unacceptable risk to health and safety, including in healthcare settings is occurring. If the TGA determines that the risk is unacceptable and that manufacturer is unable to provide sufficient evidence to support the face masks performance, the TGA may decide to cancel the entry from the ARTG.

The TGA may decide not to cancel an ARTG entry due to administrative matters that can be addressed, where these masks meet all specifications and standards, and there are no deficiencies in safety, quality, performance or presentation.

For more information about face masks visit Face masks and COVID-19.

The following entries have been cancelled from the ARTG.