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This article has been updated with additional information on: conformity assessment evidence requirements, new reliance pathway for class III devices, requirement for class III applications, medical devices containing microbial, recombinant, or animal substances and software-based medical devices.
Changes have been made to the regulation of:
- software-based medical devices
- prescription spectacle lenses
- medical devices containing microbial, recombinant, or animal substances
- medical device application audit requirements.
The changes came into effect on 15 June 2024 for:
- software-based medical devices
- prescription spectacle lenses.
The changes will come into effect on 1 July 2024 for:
- medical devices containing microbial, recombinant, or animal substances
- medical device application audit requirements.
Medical devices containing microbial, recombinant, or animal substances
Changes were made to classification rule 5.5.
From 1 July 2024, the amended rule 5.5 will only apply to medical devices that contains any of the following:
- non viable tissues, or cells, of animal origin (other than tissues or cells from hair or wool);
- derivatives of tissues or cells covered by the above (other than sintered hydroxyapatite or tallow derivatives).
The rule will no longer apply to devices containing substances of microbial or recombinant origin.
The rule will continue to not apply to devices in contact with intact skin only.
New applications
New applications for devices containing microbial, recombinant, or animal origin substances must be classified according to the amended classification rule 5.5, and any other applicable classification rules.
Existing entries
Sponsors of affected ARTG entries must submit reclassification applications before 1 July 2026. They can continue to supply under their existing ARTG entries unless the reclassification application is unsuccessful.
Conformity assessment evidence requirements
Changes to the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 as outlined in Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Amendment Determination 2024 take effect from 1 July 2024.
The changes include the removal of references to specified medical devices. Therefore, devices containing microbial, recombinant, or animal origin substances can be supported by comparable overseas approvals from a broader range of jurisdictions.
Software-based medical devices
In February 2021, we provided transitional arrangements for software-based medical devices transitioning to a higher risk classification. The transitional arrangements end on 1 November 2024.
On 15 June 2024, we amended the requirements to also allow Sponsors who had notified us they were transitioning their device to a higher classification AND had applied for a TGA conformity assessment certificate before 1 November 2024, 6 months following issue of the conformity assessment certificate to submit their application to include their device in the Australian Register of Therapeutic Goods (ARTG).
This means that Sponsors of devices transitioning to higher classifications can continue to supply their software-based medical devices if they have submitted by 1 November 2024:
- an application for ARTG inclusion OR
- an application for TGA conformity assessment.
Sponsors can then continue to supply their software-based medical devices past 1 November 2024 until their application is decided. This only applies to Sponsors who notified us before 25 May 2022.
Medical device application audit requirements
From 1 July 2024, mandatory application audits will be limited to high-risk medical devices and in vitro diagnostic (IVD) medical devices.
Mandatory application audits
Mandatory application audits will only apply to class III medical devices supported by EU Medical Device Directive (MDD) certification
Mandatory application audits will only apply to class 3 and 4 IVDs, class 3 and 4 in-house IVDs, IVDs for self-testing and IVDs for point of care testing supported by the following conformity assessment types:
- MDSAP certification
- ISO 13485 certification
- EU IVD Directive certification
New requirement for class III applications
Sponsors submitting class III inclusion applications will need to include the Clinical Evaluation Report (CER) and Instructions For Use (IFU). This requirement applies to all Class III applications except for those with conformity assessment certificates issued by the TGA.
Proposed MDSAP + 510(k) pathway for Class III medical devices
The expected legislative change to create the new pathway for Class III applications for inclusion using MDSAP + 510(k) evidence has not been drafted as anticipated.
We are working to rectify this so that we can begin to accept applications via this pathway. We will provide an update as soon as possible.
We remain available to meet with sponsors to discuss the proposed pathway – email devices@tga.gov.au to arrange a discussion.
Prescription spectacle lenses
From 15 June 2024, prescription spectacle lenses are exempt from the requirement for inclusion in the Australia Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia. More information is available at Prescription lenses: exempt medical devices.
More information
- Consultation on the regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin (pdf, 476kb)
- Consultation feedback
- Medical devices reforms: Medical device software regulation
- Proposed application audit framework for medical devices
- Public consultation: Proposed application audit framework for medical devices - Therapeutic Goods Administration - Citizen Space (tga.gov.au)
