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 no longer apply to medical devices that only contain:
- tissues, cells, or substances of microbial or recombinant origin
- tissues or cells from hair or wool, or sintered hydroxyapatite or tallow derivatives, or a combination of those, or
- materials produced by animals but are not animal tissues or cells or their derivatives (milk, honey, beeswax, or silk).
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.
Software-based medical devices
In February 2021, we introduced transitional arrangements for software-based medical devices transitioning to a higher risk classification. From 15 June 2024, an alternate transition pathway will apply for manufacturers or sponsors of transitional ARTG entries who have submitted a TGA conformity assessment certificate application.
Pathways to meet transitional arrangements
The manufacturer or sponsor of transitional ARTG entries will need to:
- submit an application for ARTG inclusion or
- submit an application for TGA conformity assessment
by 1 November 2024.
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
- MDSAP certification and US FDA 510(k) approval
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
