Clarification: This safety alert was updated on 23 April 2020 to clarify the status of non-sterile face masks as consumer goods and to add a link to further information on the TGA website.
The COVID-19 pandemic has seen an increase in demand of certain goods such as face masks. If you wish to supply face masks you need to consider whether you are supplying surgical or non-surgical face masks as they are regulated differently.
If you are supplying non-surgical face masks you should be aware of your responsibilities under the Australian Consumer Law (ACL). Here’s what you need to know.
TGA regulated face masks
The Therapeutic Goods Administration (TGA) regulates face masks presented or claimed to be for therapeutic use. These masks are designed specifically for surgical use, to reduce or prevent the transmission of disease or micro-organisms such as bacteria or viruses, and would meet the definition of a medical device under the Therapeutic Goods Act 1989.
If these face masks are supplied as non-sterile, they are likely to be regulated as low risk, class I medical devices.
Masks and gowns for use in an Australian hospital setting should be included on the Australian Register of Therapeutic Goods (ARTG).
ACL and consumer guarantees
Non-sterile face masks that are designed as safety or protective apparel for use in the home or for recreational or occupational use are consumer goods that are excluded from regulation by the TGA.
Suppliers of face masks not regulated by the TGA have responsibilities under the ACL that include:
- ensuring that the face masks supplied in the Australian marketplace are safe and fit for purpose
- complying with the consumer guarantees regime, ensuring that the goods are of acceptable quality, including that they are safe, durable and with no faults
- not making false or misleading claims regarding protection against viruses.
The ACCC does not have any role in administering the import of face masks that are considered consumer goods. If you have any queries regarding the duties and taxes related to importing face masks or any other specific goods, we recommend you contact the Department of Home Affairs.
TGA: Regulation of personal protective equipment and COVID-19
ACCC advice to suppliers of hand sanitiser
ACCC advice to consumers on COVID-19 (coronavirus)
TGA: COVID-19 advice on surgical masks and gowns