TGA Medical Device Reclassification Australia – 2024 Requirements
Alert Call for Medical Device Manufacturers who are looking to place the Spinal Implantable or any other type of Medical Devices in the Australian market (via the TGA Medical Device approval or notification process). It is time for you to revisit the regulations and brainstorm on your next steps.
Elexes has supported 25+ TGA submissions including IVD & SaMD reclassifications in 2022–2024. As a TGA Regulatory Affairs Lead, use this guide to avoid reclassification penalties and stay compliant.
TGA reclassified a number of medical devices to align its legislation with that of the European Union (EU) as a part of the reforms. On November 25, 2021, this became effective, and by May 25, 2022, all manufacturers and sponsors (who are already selling in the Australian market) must notify TGA that they have reclassified their medical devices and hence can continue to distribute and supply such devices.
Similarly, certain implanted spinal medical devices have been reclassified and are required to meet enhanced quality management systems, technical documentation, and clinical evidence requirements. Medical devices that come into direct contact with the spinal column and were previously classified as Class IIb medical devices are now reclassified as Class III medical devices. All manufacturers or sponsors of spinal implanted medical devices need to follow the new restrictions based on the product’s TGA designation and if they don’t want to continue marketing the device in Australia, they can terminate their Australian Register of Therapeutic Goods (ARTG) license before May 25, 2022.
Your Options for Compliance
Now if you are making a medical device and thinking about what to do here for compliance in Australia, the following is something you can ponder over:
- Devices included in the ARTG before November 25, 2021, require notification to TGA and submission of a reclassification application by November 1, 2024.
- If needed, you can include your product in the ARTG before November 25, 2021, you must have notified TGA and submitted an application under the classification as per previous regulations before November 25, 2021.
- You are planning to place your device on or after November 25, 2021, you shall submit a Class III Device Application.
If manufacturers and sponsors fail to meet their commitments under these transitional arrangements, their devices will still be considered Class III medical devices, and they will be compelled to stop selling them.
In summary, as part of reclassification, you’re expected to notify TGA and file the product under the new classification, as applicable, if you decide to continue the supply of your device into the Australian market.
Given that there are severe repercussions for not being able to comply with the updated Australian requirements, it’s important to act today.
Please do not hesitate to drop a line at jennifer@elexes.com and we can certainly talk and discuss what’s the best approach moving forward.
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FAQs
Which devices are affected by TGA reclassification in 2024?
Devices such as active implantable devices, spinal implants, devices in direct contact with heart/central circulatory or nervous systems, and substance-based devices (e.g. inhalation devices, skin-applied gels/creams) are affected.
What is the deadline to comply with TGA’s new rules?
For many reclassified devices existing in the register, you must submit the new ARTG inclusion by 1 November 2024.
Do I need to reapply for TGA approval for my SaMD?
If your software qualifies under the reclassification (e.g. as “software-based medical device”), yes — new applications must follow updated classification rules effective from 15 June 2024.
Are Class I IVDs now Class III under new TGA rules?
No — there is no blanket reclassification of all Class I IVDs to Class III under current changes.
How does Australia’s TGA compare with EU MDR classification?
TGA’s recent reclassification partly aligns with the risk-based approach of the EU Medical Device Regulation (MDR), moving higher-risk devices to higher risk classes, but implementation timelines and certain classification rules (e.g. substance/skin-applied devices) remain specific to TGA.
