TGA consults on proposed refinements to regulation of personalised medical devices

The TGA, Australia, is consulting on proposed refinements to the regulation of personalised medical devices.

On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as ‘personalised’ medical devices).  The key change introduced under the Framework is a change to the definition of a custom-made medical device.

Included is a transition period for eligible manufacturers and sponsors until 1 November 2024.

Why is the TGA considering refinements to the new regulatory framework?

The TGA has received a range of feedback and information during the course of introducing the Framework, including concerns from some sectors about the impact of the changes. This includes comments that:

  • the new regulatory requirements are 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 on potential refinements to the Framework that could be considered. This is to ensure that the risks associated with personalised medical devices are appropriately mitigated without imposing unnecessary administrative and regulatory burden.

Where can you find further information on the consultation?

Further information is available in the consultation document, here.

Where can you provide feedback to the consultation?

You can provide feedback via the consultation hub, here.

What are the start and end dates of the consultation?

Start date: 7 June 2021

End date: 5 July 2021

Source: TGA website