Philips Electronics Australia Ltd fined $133,200 for alleged breaches of therapeutic goods legislation

The Therapeutic Goods Administration (TGA) has issued ten infringement notices totalling $133,200 to Philips Electronics Australia Ltd. The company allegedly breached the Therapeutic Goods Act 1989 by failing to provide information to the TGA in the timeframes required by law, on the deterioration in the characteristics or performance of several Philips products.

The products included Philips CPAP and bi-level PAP (Continuous or bi-level Positive Airway Pressure) machines used for individuals with sleep apnoea, and mechanical ventilators. Failure to provide information on deterioration of performance of these critical medical devices could lead to a serious deterioration in the user's health.

Infringement notices of $13,320, for each have been imposed for each of 10 Philips entries in the Australian Register of Therapeutic Goods.

Under the Act and related regulations, sponsors and manufacturers of medical devices must report certain incidents and performance issues about medical devices to the TGA.

The TGA has published regulatory guidelines for importers, suppliers, and manufacturers of medical devices, as well as information on post-market review of ventilators, CPAP and Bilevel PAP devices and Philips recall action.

The TGA's highest priority is to protect the health and safety of the Australian public through the regulation of therapeutic goods. Suppliers of therapeutic goods must meet their ongoing post-market safety and performance monitoring commitments.