The Therapeutic Goods Administrator (Australian regulatory of medicines and devices) publishes regular notices to industry via it’s website on points considered relevant for the market. A Notice published on June 9 identified that after many years of industry requests for faster market approvals for higher risk devices, TGA will be looking to increase resourcing with regard to the review of clinical evidence, potentially speeding up applications for High Risk applications requiring application audits.
At Brandwood Biomedical, we have seen a recent trend from the regulator which appears to have successfully balanced the risk of the product and the need for increased speed to market for the lower class devices (Class lm/s, lla and llb). Our recent projects show a turnaround for some ARTG applications for these lower risk devices as being days (instead of months as seen in past years). Having now succeeded with the lower class applications, the regulator may have finally identified for the best method to alleviate the congestion during the submissions and application audits of the high risk devices.
Currently, high risk devices can take several months for the approval to go through, even with great quality documentation and prior approvals in Europe under a reputable notified body. Hopefully now with an increase in numbers of Medical Officers, we’ll start to see an improvement in getting the higher risk applications through and onto the Australian market sooner.
If you’re interested in gaining approvals in Australia, or would like to understand the process of supply in Australia enabling you to better understand the market access, don’t hesitate to give us a call in our Sydney office.