Australia Conducts Postmarket Review of COVID-19 Face Masks

Australia’s Therapeutic Goods Administration is conducting a postmarket review of face masks in response to concerns about the quality of some masks cleared for use during the coronavirus pandemic.

The agency said devices must be listed on the Australian Register of Therapeutic Goods and that manufacturers must supply the following documents for a postmarket review:

• A conformity assessment certificate;
• A list of models and the states within Australia where the masks are distributed;
• Details of the manufacturing standards and evidence of compliance;
• A copy of all packaging and labeling;
• A copy of the Instructions for Use; and
• Evidence from a clinical trial or testing from an accredited laboratory to support a claim that the device can protect the wearer from COVID-19.