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The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued eight infringement notices totalling $106,560 to Sydney-based company Life Biotech Pty Ltd (Life Biotech) for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.
"There are serious consequences for failing to respond to the TGA's requests for information or samples in a timely manner and for providing inaccurate information," Adj. Professor John Skerritt, Deputy Secretary of the Department of Health said.
The TGA required Life Biotech to provide information and samples as part of a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). Life Biotech allegedly failed to comply with a number of notices requiring it to provide information and samples, and also allegedly provided partial, late and misleading responses to other requests.
Under the Therapeutic Goods Act 1989 (the Act), importers and manufacturers of therapeutic goods have ongoing responsibilities with respect to medical devices included in the ARTG. They must facilitate access to technical documentation to demonstrate compliance with essential principles, and prove that conformity assessment procedures have been applied. When the TGA issues a notice under the Act requiring information to be provided about compliance with these requirements, this information must be provided within specified timeframes. The Act also allows the TGA to require samples of medical devices, and to specify the period in which they are to be supplied.
The TGA has published regulatory guidelines for importers and manufacturers of medical devices, as well as information on face masks and COVID-19.
The TGA's highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods.
The TGA takes action against breaches of the Act
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
If you suspect non-compliance, you can report illegal or questionable practices online to the TGA.
Suppliers of therapeutic goods must meet their ongoing responsibilities with respect to post-market vigilance and monitoring. The TGA encourages potential suppliers to be aware of the requirements for supplying therapeutic goods in Australia.
The TGA has published information to assist with the understanding of therapeutic goods regulation and legislation.
Contact for members of the media
- news@health.gov.au
- 02 6289 7400