Therapeutic Goods Administration (TGA) Personalised Medical Device Framework

April 2021 – An invitation circulated through eNEWS asking for expressions of interest to participate in a Steering Group to represent members.

April 2021 – An AHTA TGA Steering Group, was formed – a composition of 8 AHTA members.

10 May 2021 – A webinar meeting was held with a presentation from Rebecca Batesman, TGA, to address issues of concern in relation to proposed changes and the impact of those changes on Hand Therapy.

9 June – The TGA provides a transcript of the member webinar and Q&A to the AHTA – addressing all of the questions posed to the presenter in the ‘chat’ function on the webinar platform.

9 June 2021 – the TGA called for submissions by 14 July 2021 to a “Consultation: Proposed refinements to the regulation of personalised medical devices.” 

10 June 2021 – The AHTA Steering group is considering the consultation document and will make recommendation. The Steering Committee is working on behalf of all members.

Of Note: page 7 of the “Consultation: Proposed refinements to the regulation of personalised medical devices.

We have 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.  Manufacturers and sponsors of patient-matched medical devices includes the following healthcare professionals who produce or import devices for treating their patients:

  • ......
  • Hand therapists
  • Prosthetists
  • Osteopaths.

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; 
  • the requirements for some devices were excessive compared with the actual risk posed by the device; and/or
  • the regulatory burden imposed by the introduction of the Framework 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.”

And on page 11

“It is considered that where a medical device has been “prescribed” by a registered health professional and is manufactured by a qualified or accredited professional according to the specifications provided by the healthcare practitioner, risks can be adequately mitigated.  

Examples where Class I (low-risk) patient-matched medical devices could be exempted are where they are being manufactured:

  • .......
  • By a health professional registered with the Australian Health Practitioner Regulation Agency (AHPRA) under the Health Practitioner Regulation National Law Act 2009, and whose scope of practice encompasses production of the patient-matched medical devices that they are producing; and
    The devices they produce are intended to be used by a patient of the healthcare facility, registered provider or AHPRA-registered health professional.”