Medical device regulation changes

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: 

1. an application for ARTG inclusion OR
2. 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 and MDSAP certification + 510(K) evidence.

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. 

New premarket pathways for devices with US FDA exemptions

On October 19, 2024, two new approval pathways for devices with US FDA exemptions started. We have accepted premarket application for devices with US FDA approvals since 2018 and the new pathways fill gaps in those arrangements for some devices.

The new pathways rely on the manufacturer having quality management system certification from a Medical Device Single Audit Program (MDSAP) auditing organisation that includes Australian requirements. 

The sponsor will need to submit the MDSAP certificate as Manufacturer’s Evidence before applying to include the device in the Australian Register of Therapeutic Goods (ARTG).

One of the new pathways is for Class IIa devices that are exempt from US FDA 510(k) requirements. The sponsor will need to be able to provide evidence that their device is covered by the US FDA exemption – see US FDA website for a list of these exemptions.

The other pathway is for Class III devices that do not need to satisfy US FDA PMA requirements and hold 510(k) clearance issued by the US FDA. Apart from evidence of the 510(k) clearance, the sponsor will need to provide the clinical evidence and Instructions For Use (IFU) for the device with their application. 

For more details see: Supporting documentation for inclusion of a medical device.

These applications will be selected for a mandatory Level 2 audit and there will be an assessment fee. See: Summary of fees and charges to applications submitted to the TGA. Our audit will focus on ensuring the clinical evidence demonstrates safety and performance for the device.

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) before import, export or supply in Australia. See Prescription lenses: exempt medical devices.