Public consultation open

Posted: 10th of June, 2021

Potential refinements to the new regulatory framework for personalised medical devices

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.

Comprehensive information about the new framework is available via the personalised medical devices landing page on the TGA website.

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.

The TGA is now seeking feedback through a public consultation process on potential options for refining the framework that will ensure risks associated with the production and supply of personalised medical devices are appropriately mitigated, without imposing unnecessary administrative and regulatory burden.

The consultation closes at 11:59pm on Wednesday 14 July 2021.

GSA members are encouraged to provide feedback on the proposed options for refining the framework.

Information about the consultation, including information about how to submit a response, is available on the TGA website.