Australia: An update on the TGA’s post market review of face masks and important changes to the process for listing Class I medical devices in the ARTG

By Lynne Lewis, Katrina Dang, Dylan McGirr

02-2021

The Therapeutic Goods Administration (TGA) announced in mid-2020 that it is conducting a post market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). The announcement came after an increase in the demand, importation and sale of face masks and other personal protective equipment in response to the COVID-19 pandemic. The TGA has also implemented key changes to the process for including Class I non-sterile, non-measuring medical devices in the ARTG.

Purpose of the review

The post market review is designed to ensure that face masks which are intended for therapeutic use and are thus medical devices are performing effectively and meet the requirements of the TGA’s Essential Principles (Principles). In addition to the post market review, the TGA Laboratories are conducting their own testing of face masks to assess their quality and ensure their compliance with performance criteria.

A key concern of the TGA is that face masks which qualify as medical devices are not meeting the requirements set out in the Principles. The Principles provide design and manufacturing requirements to ensure that medical devices are safe and perform effectively. This includes that face masks meet applicable Australian or international manufacturing standards. Medical devices must also comply with the relevant standards on labelling, application, and advertising.

The TGA is also taking into consideration any safety notices issued by Health Canada or the US Food and Drug Administration as part of the post market review.

Review process

As part of the post market review, the TGA is currently auditing face masks included on the ARTG to check their effectiveness. At the request of the TGA, sponsors must provide information about the face mask’s manufacturing standards, the number of products manufactured, the product’s packaging and labelling, the instructions for use, and any evidence that the product is intended to prevent the spread of COVID-19. If face masks are labelled with common labelling terms such as P2, KN95, FFP2 or N95, the sponsor must be able to produce evidence from the manufacturer to support these claims.

Results of the review (thus far)

At this stage of the post market review, the TGA has found that some face masks are not meeting regulatory requirements, such as labelling, or have failed TGA testing. Certain manufacturers have been asked to issue a Product Defect Alert or a Product Notification that explains the concern for the benefit of consumers.

Manufacturers that have been issued with an alert or notification are not required to remove their products from the market where the issues relate to labelling deficiencies. Where the issues identified are substantial, the TGA has cancelled these listings from the ARTG.

The TGA has published the results from the testing conducted by the TGA Laboratories which measure the performance of listed face masks against a range of attributes including visual inspection, fluid resistance, particle filtration, and sterility.

Changes to the process for including specific Class I medical devices in the ARTG

In addition to the post market review, the TGA has amended the process for including Class I non-sterile, non-measuring medical devices on the ARTG. Under the new process, applicants need to provide a manufacturer’s declaration of conformity with their application to include the medical device in the ARTG as opposed to simply holding the documentation.

The TGA will also assess applications for compliance with the legal requirements for Class I medical devices. If the TGA is not satisfied that the medical device meets the requirements, they will select the application for non-mandatory audit.

All Class I medical devices included in the ARTG will continue to be subject to post market reviews.

Key takeaways for sponsors of face masks
  1. It is crucial that sponsors of face masks comply with any notices issued by the TGA, including requests for information or requests for face mask samples. Failure to comply with any TGA notices can result in significant penalties. The TGA recently issued eight infringement notices totalling $106,560 to Life Biotech Pty Ltd for allegedly failing to provide information and face masks samples to the TGA as part of the post market review.

  2. To satisfy the audit process, manufacturers and suppliers should ensure they have prepared the necessary documents, which includes a declaration of conformity and a copy of any technical documentation which clarify the purpose of the face mask.

  3. New sponsors of face masks must submit a declaration of conformity with their application to include class I medical devices in the ARTG.