Regulatory changes introducing a new framework for the regulation of personalised medical devices commenced on 25 February 2021, including a transition period for eligible manufacturers and sponsors until 1 November 2024.
During the implementation phase a number of sectors have raised concerns over the impact of the new framework including comments that the new regulatory requirements are:
a duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
the classification of certain requirements for some devices were excessive compared with the actual risk posed by the device; and/or
the regulatory burden associated with compliance is unreasonable.
We are now seeking feedback on potential refinements to the Framework that could be considered to ensure risks associated with personalised medical devices are appropriately mitigated without imposing unnecessary administrative and regulatory burden.
This consultation, including the consultation paper, were published on the Department of Health consultation hub.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.