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Medical devices reforms: Personalised medical devices

Project status: in progress

21 June 2021

Please note: While submission of a notification to the TGA is required within two (2) months of initial manufacture/supply of a custom-made medical device, many stakeholders have not been meeting this obligation. If you were supplying a custom-made medical device prior to 25 February 2021, you should submit your notification as soon as you are able and before you register for transition. The TGA will not be pursuing compliance action against stakeholders who do not submit their notification before 25 February 2021.

Project overview

A new framework has been introduced to ensure an appropriate level of regulation is applied to Personalised Medical Devices to manage the risk these devices may pose.

Prior to 25 February 2021, most personalised medical devices (PMD) met the definition of 'custom-made' and were exempt from the requirement to be approved by the TGA and included in the Australian Register of Therapeutic Goods (ARTG) before they could be imported, exported or supplied (though they were subject to other regulatory obligations).

Over the past two decades, rapid advances in computing technology and materials science have resulted in significant changes to medical imaging technology, manufacturing technology and, as a result, medical device technology. Newer methods of manufacture such as 3D-printing allowed more complex and, in some cases, higher-risk medical devices to be personalised for an individual patient and supplied under the custom-made medical device exemption.

Following extensive consultation and liaison with other global regulators, the Therapeutic Goods Administration (TGA) developed a new regulatory framework for PMD. This new framework has been introduced by the Government to ensure an appropriate level of regulation is applied to PMD in order to manage the risk they may pose. The new framework came into effect on 25 February 2021, and includes:

  • new definitions for personalised medical devices, including patient-matched and adaptable medical devices, that reduce the scope of the custom-made medical device exemption
  • changes to the conditions of exemption for custom-made medical devices
  • new requirements for the inclusion of Medical Device Production System (MDPS) in the ARTG.

MDPS are a new concept in medical device regulation where an end-to-end system for the manufacture of medical devices can be included in the ARTG, thereby allowing medical devices to be manufactured within healthcare facilities without the need for the facility to include those devices in the ARTG. While the definition of an MDPS is included 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 subsequent legislative instrument is likely to be drafted following work currently underway with the International Medical Device Regulators Forum (IMDRF) and once the TGA has established regulatory structures to appropriately assess and evaluate these systems. This work is progressing over 2021-22.

Guidance for industry

A guidance document for the new regulatory framework for PMD is available at: Personalised medical devices (including 3D-printed devices).

For answers to frequently asked questions about the framework, see Regulatory framework for personalised medical devices: Frequently asked questions.

Consultations

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

For more information see Consultations and reviews.

Dental Sector Working Group

On 9 April 2021, the TGA held a workshop with key representatives of the Australian dental sector to discuss the implementation of the new regulatory framework for personalised medical devices in the specifically in the dental sector.

Following on from this workshop a working group of volunteers has been established to continue to work closely with the TGA, providing input, advice and feedback on the implementation and concerns raised by the sector.

For more information see Personalised medical devices: Dental Sector Working Group

Keep up to date

Please contact the TGA at devices@health.gov.au if you have any queries or comments.

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For more information about other reforms visit Medical devices reforms.