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The Therapeutic Goods Administration (TGA), part of the Department of Health, has issued two infringement notices totalling $26,640 to Sydney company Aidacare Pty Ltd (Aidacare). The company allegedly breached the Therapeutic Goods Act 1989 (the Act) by failing to provide information requested by the TGA in relation to face masks in the Australian Register of Therapeutic Goods (ARTG).
As part of a post-market review of face masks and respirators included in the ARTG, the TGA required Aidacare to provide information about the face masks they had entered in the ARTG. Aidacare allegedly failed to comply with several notices requiring the company to provide information about these face masks.
Under the Act, importers and manufacturers of therapeutic goods have ongoing responsibilities with respect to the medical devices they have 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 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 breaches of the Act. 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.
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.
If you suspect non-compliance, you can report suspected non-compliance or questionable practices online to the TGA.