Adverse Events Increase in Australia
During August, the Therapeutic Goods Administration (TGA) published their 2017 overview of post-market monitoring in Australia. The report shows a sharp increase in the reporting of Adverse Events from 2017, where the TGA received 5,370 adverse event reports relating to medical devices (compared with just 3,838 in 2016). The increase has primarily been as a result in reports submitted by the local Australian Sponsors. This is also likely due to an increase in post-market vigilance globally.
In Australia, it is mandatory under the Therapeutic Goods Act 1989 for sponsors and manufacturers to report adverse events that have led to or could have led to a death, serious illness or injury to a patient, the person using the device or others. This does slightly differ to some other jurisdictions who do not require a report for near misses.
As most manufacturers are aware, the adverse events can trigger post-market reviews by the TGA. These reviews help determine if the devices continue to meet safety and performance requirements and also ensure the sponsor is in compliance with the conditions of inclusion on the ARTG following their supply in the Australian market. These reviews can have several outcomes, from a need for improvements in design, changes to the supporting documents, or even suspension/removal of the device from the ARTG. Any of these can also trigger recalls or safety alerts.
With the increase in post-market surveillance, it is becoming critical that the manufacturer is fully aware of their requirements in Australia and just as important that the Sponsor is meeting their own obligations. It’s for this reason that whether you’re a distributor or manufacturer, that you have local experienced regulatory experts to provide oversite and surveillance of your regulatory position and have support available when things go wrong.
If you’re in a position of a manufacturer or sponsor and not sure whether your regulatory responsibilities are under control, give Brandwood Biomedical a call to discuss how our Sponsorship Services can provide your team with reassurance. Contact us to discuss your needs and how we can help. You can drop us an Email [email protected] or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)