Australia: TGA Changed Regulation on Device Exemption for Certain Software and Customised Device


TGA announced change of regulations for Software including Software as a Medical Device (SaMD). and Personalised/Customised Device including 3D Printed Device, to be effective 25 February 2021. Please refer to below on the type of products that are exempted/excluded and the products that remain regulated.


Software including Software as a Medical Device (SaMD)

Consumer health life-cycle prevention, management and follow up




Enabling technology for telehealth, remote diagnosis, health care facility management




Digitisation of paper based or other published clinical rules or data



Population based analytics



Laboratory information management systems (LIMS) and Laboratory information systems (LIS)


See Software as in vitro diagnostic medical devices (IVDs) for more detail.





Personalised/Customised Device



Custom-made medical devices

• Continue to be exempt from inclusion in the ARTG

• Excludes

o Patient-matched devices (new definition)

o Adaptable medical devices (new definition for an existing concept)

• New obligations

o Information to be supplied with the device

o Record keeping requirements

1. a minimum of 5 years after the date of manufacture if the device is non-implantable; or

2. a minimum of 15 years after the date of manufacture if the device is implantable.

o Annual reporting

o Inspection and review




Patient-matched medical devices

• Manufactured within a “design envelope”

• Production processes can be validated, verified or reproduced

• No longer exempt – must be included in the ARTG

• Notify the TGA by 25 August 2021 to access transition arrangements

• Submit an application for inclusion before 1 November 2024



Medical Device Production System (MDPS)

• A validated, multi-component design and production system that a manufacturer can supply to health professionals and healthcare facilities, to produce a specific type of personalised medical device in-house.

Important Notes

• Read the guidance

• Take the stakeholder survey

• Register for transition by 25 August 2021

-Custom-made to patient-matched

-Reclassification

• For custom-made devices – submit your first annual report by 1 October 2021

• Submit your application for inclusion/reclassification by 1 November 2024





Source: TGA

Regulation of software based medical devices

Personalised medical devices

Personalised Medical Devices Framework


Contact us at info@arqon.com for more details

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