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Medical devices reforms: personalised medical devices

Project overview of the regulatory refinements for personalised medical devices.

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Project overview

Personalised medical devices are medical devices that are designed and manufactured, or adapted/modified, to meet the needs of an individual. 

A regulatory framework for personalised medical devices came into effect on 25 February 2021. The framework addresses emerging risks from technologies like 3D printing, which are increasingly used in personalised device manufacturing. It includes:

  • New definitions for personalised medical devices, including patient-matched and adaptable medical devices
  • Changes to the exemption for custom-made medical devices
  • The introduction of ‘Medical Device Production System’ (MDPS) as a new category of device.

Personalised medical devices

Patient-matched medical devices (PMMDs)

Under the framework, most devices previously supplied under the custom-made medical device exemption now meet the definition of a patient-matched medical device (PMMD). PMMDs are currently exempt from inclusion in the ARTG until 1 July 2029. They can be manufactured and/or supplied until then under this exemption.

Unlike other medical devices, most PMMDs are manufactured at the point-of-care (within the healthcare setting), usually with direct involvement from a health professional. Based on stakeholder feedback, we are currently exploring refinements to PMMD regulation. These refinements are being considered in parallel with the point-of-care manufacturing of medical devices project, outlined in the next section.

Point-of-care manufacturing of medical devices

A project to further review the personalised medical devices framework in the context of point-of-care manufacturing is underway. We are working closely with key stakeholders on this.

Custom-made medical devices (CMMDs)

Most devices designed and manufactured for an individual are PMMDs. Very rarely, a device meets our definition of ‘custom-made medical device’ (CMMD) under the framework. These are regulated differently to PMMDs. We are not considering refining CMMD regulation at this point.

Medical Device Production Systems (MDPS)

A Medical Device Production System (MDPS) is an end-to-end system to produce medical devices in a healthcare facility. It is a new regulatory concept in point-of-care manufacturing. 

MDPS is defined in the Therapeutic Goods (Medical Devices) Regulations 2002. This definition will not take effect until a subsequent legislative instrument declaring an MDPS to be a medical device is in place. This work is ongoing.

Consultations

ConsultationStatus
Proposed refinements to the regulation of personalised medical devicesConsultation closed
14 July 2021
Proposed regulatory scheme for personalised medical devices, including 3D-printed devicesConsultation closed
31 March 2019
Proposed regulatory changes related to personalised and 3D-printed medical devicesConsultation closed
22 December 2017

For more information see Consultations and reviews.

Keep up to date

For questions or comments, contact us at devices@tga.gov.au.

You can also send an email to devices@tga.gov.au with ‘SUBSCRIBE PMD’ in the subject line to receive:

  • notifications when guidance documents and other information resources are published
  • updates about the framework
  • details about webinars and workshops.

More information

Product types

Page history

Show all page updates (1)

Removed repeated information.

Added ‘Point-of-care manufacturing of medical devices’, ‘Custom-made medical devices’ and ’Keep up to date’ sections.

Updated links.

Removed repeated information.

Added ‘Point-of-care manufacturing of medical devices’, ‘Custom-made medical devices’ and ’Keep up to date’ sections.

Updated links.