Proposed refinements to the regulation of personalised medical devices

Closed 21 Jul 2021

Opened 7 Jun 2021


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.

Custom-made medical devices are exempt products. In Australia, all medical devices must be approved by the Therapeutic Goods Administration (TGA) and included in the Australian Register of Therapeutic Goods (ARTG) before they are supplied, unless they are exempted. While exempt products do not require pre-market approval from the TGA, the manufacturers and suppliers of these products are still subject to post-market regulatory obligations such as reporting adverse events to the TGA, and keeping records of the devices that they supply.

Most of the products that met the former definition of a custom-made medical device, and were therefore exempt, do not meet the new definition introduced under the Framework. If a medical device does not meet the new definition of custom-made introduced under the Framework, then it must be approved by the TGA and included in the ARTG. There is a transition period that will allow manufacturers and suppliers of these products until 1 November 2024 to undertake this process.

There are a number of health professionals in particular who produce and/or import personalised medical devices for treating their patients that will be impacted by this change, including:

  • Dentists, prosthodontists and orthodontists;
  • Dental technicians;
  • Dental prosthetists;
  • Orthotist/prosthetists;
  • Rehabilitation engineers;
  • Radiation therapists;
  • Audiologists;
  • Hand therapists; and
  • Osteopaths.

Why your views matter

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.

In some cases it was claimed that the regulatory requirements were:

  • a duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
  • excessive when compared with the actual risk posed by the device; and/or
  • unreasonable in terms of regulatory burden.

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.

Consultation paper

The consultation paper provides details about proposed refinements to the new framework for the regulation of personalised medical devices and poses questions to guide responses to the consultation.

Consultation paper: Proposed refinements to the regulation of personalised medical devices


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