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Source: Australian Department of Health

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks that are included in the Australian Register of Therapeutic Goods (ARTG).

This page will be updated throughout the review to provide a summary of any regulatory or other action taken against individual products as a result of this post-market review.

Background to the review

COVID-19 has increased the demand and supply of personal protective equipment (PPE) such as face masks and respirators, gloves, face shields, goggles, and gowns which are designed to protect the wearer from the spread of disease, illness and infection.

Some of these products meet the definition of a medical device and must be included in the ARTG before they are supplied. Some of these products do not meet the definition of a medical device and while they may still be used to prevent the spread of diseases, including COVID-19, they do not need to be included in the ARTG.

For more information about the use and regulation of PPE, including face masks and respirators, please review:

Due to a rapid increase in demand for the manufacturing, importation and sale of face masks, there has been an increase in medical device inclusions in the ARTG, many of which are manufactured and imported from overseas.

A number of concerns have been raised about the quality and effectiveness of some of these products, particularly face masks, including that they:

  • are included in the ARTG but do not meet the legislative requirements for medical devices; or
  • may not, or do not, perform as intended.

The review will ensure devices included in the ARTG meet all regulatory requirements and perform as intended.

The following guidance contains information for individuals and organisations who:

If you supply face masks

If you are the legal entity responsible for importing and supplying face masks (sponsor), you must ensure that all regulatory requirements relating to your products are met. You should also:

  • Determine if your product meets the definition of a medical device. If your product does meet the definition of a medical device, you should ensure that it is included in the ARTG before you import and/or supply it.
  • Ensure you have the following evidence available to provide to the TGA when requested as part of the post-market review:
    • declaration of conformity (Conformity assessment certificate)
    • a list of models of masks, supply numbers by model and year (if applicable), and the states within Australia where you have distributed the face masks
    • details of the manufacturing standards the devices conform to and evidence of compliance
    • a copy of all packaging and labelling
    • a copy of the Instructions for Use that are supplied with your product (if applicable)
    • where the intended purpose of the device claims to protect the wearer from COVID-19, either specifically or by implication, appropriate evidence to support such a claim (evidence from a clinical trial, or testing from an accredited laboratory to a recognised standard, for example).

Note

If you are the supplier of a medical device in Australia, it is your responsibility to ensure all regulatory requirements are met.

There are civil and criminal penalties associated with supplying a medical device that is not included in the ARTG, and for providing false or misleading information to the TGA.

If you are supplying a device that does not meet the regulatory requirements, the TGA strongly recommends that you cease supply and cancel your ARTG inclusion.

If you use face masks

Personal protective equipment (PPE), including face masks, gowns and gloves, which are presented or claim to be for therapeutic use must meet the definition of a medical device. For example, surgical or examination masks intended to reduce or prevent the transmission of disease or micro-organisms (such as bacteria or viruses) are medical devices. These products are regulated by the TGA and will need to be included in the ARTG before they can be supplied.

If you are a consumer of these products, you should familiarise yourself with the differences in available face masks and be aware of the manner in which these products are used in order to maximise the protection they can offer. In particular:

  • While other languages can also be used, medical devices must be supplied with the labels, packaging and Instructions for Use in English.
  • The name and address of the supplier, and the name of the manufacturer, should be provided on the packaging or label.
  • You can check that a face mask is included in the ARTG by searching the ARTG using the name of the person or company legally responsible for the product (sponsor). Product names are not available in the ARTG.
  • Face masks are supplied as both medical devices and as personal protection for use in industrial settings.  Ratings such as N95 and P2 relate to standards that may not be associated with a therapeutic use.  You should familiarise yourself with the specific claims and ratings associated with the product you are using to ensure it is appropriate for the manner in which you intend to use it. Standards Australia have published a Summary of information on standards and conformance for PPE products that outlines the factors that are assessed under each standard.
  • Ensure that you always use your medical device in the manner intended by the manufacturer by following the Instructions for Use.
  • Be aware of potentially counterfeit devices.  Look at product markings, such as the name of the manufacturer, to determine whether anything is amiss (incorrect spelling, faded packaging, incorrect filters/materials, etc.).

Reporting concerns

The TGA has online forms for reporting any concerns or issues:

For more information about reporting medical device adverse events and frequently asked questions, see Medical device incident reporting & investigation scheme (IRIS).

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