Early Warning Mechanisms for Australia and New Zealand

The Therapeutic Goods Administration (TGA) and Medsafe, the Australian and New Zealand regulatory authorities for medical devices (and medicines) are in the process of developing an early warning system for adverse event and recall situations. The system is one of many projects being worked on as part of the creation of one regulatory agency, the Australian New Zealand Therapeutic Products Agency (ANZTPA).

The early warning system is still in the developmental stages and key considerations such as alert mechanisms, the information to be provided, applicable levels of safety risk, current and expected regulatory resources, and post implementation measures are being explored by stake holders.

The current system place for medical devices includes alerts recorded on the TGA or Medsafe websites however this is often once the adverse event has been identified and addressed to some level. ANZTPA can only improve on this mechanisms of information delivery.

No official structure or guidance has yet been released by the TGA or Medsafe. It is expected that medical device manufacturers will be responsible for carrying out timely information submissions to ANZTPA, however current regulatory timeframes for adverse event reporting are unlikely to be changed.  KD&A will provide further detail on what the early warning system means for medical device manufacturers as soon as it becomes available.

For guidance completing post market activities for your medical device, visit our post market surveillance page or contact KD&A.