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Post-market review of face masks: Cancelled ARTG entries

26 November 2020

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

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.

For example, the TGA may decide not to cancel an ARTG 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.

The following entries have been cancelled from the ARTG.