The TGA has published a list of changes to medical device regulations. The table below is an attempt to present the information in a manner such that it can be read easily.
| Devices or audit application requirements | Changes already in effect from 15 June 2024 | Changes that will come into effect on 1 July 2024 plus pathways to meet changes already in effect |
|---|---|---|
| Software-based medical devices | In February 2021, TGA 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 TGA before 25 May 2022. |
| 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. | – |
| 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. |
| 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 |
Further information is available at the link below.
Source: TGA