What Has Changed?
The Therapeutic Goods Administration (TGA) recently announced that they have received Government approval to extend the transition period affecting most reclassified devices, as well as patient-matched devices, extending the deadline from 1 November 2024 to 1 July 2029.
The Government recently agreed to extend the deadlines because of the impact of the European Union Medical Device Regulations (EU MDR) transition extension.
Regulatory amendments are underway and are expected to be in place by the end of 2023.
The extended deadlines would give manufacturers of legacy devices more time to obtain EU MDR certificates (or other appropriate overseas approvals), before the end of the EU MDR transition on 31 December 2028, and for sponsors to apply to the TGA for inclusion of those devices in the ARTG before 1 July 2029.
What Devices are Affected?
The extended transition deadlines affect a range of devices subject to re-classification, which were previously included in the ARTG prior to 1 November 2021, and where the sponsor notified the TGA of the need to reclassify the devices before 25 May 2022.
The types of reclassified devices that can take advantage of the extended transition deadline are:
- Active medical devices for therapy with diagnostic function (including any related software)
- Spinal implantable medical devices (motion preserving)
- Devices used in direct contact with the heart, central circulatory system, or central nervous system (including any related software)
- Devices that administer medicines or biologicals by inhalation (including any related software)
- Devices that are substances introduced into the body via body orifice or applied to the skin (including any related software)
Currently, sponsors have until 1 November 2024 to re-apply for these devices to be included in the ARTG at the higher classification, but this deadline will be extended to 1 July 2029 once the Government amends the regulations later in the year.
The deadline for the transition of patient-matched medical devices has been agreed to be extended to 1 July 2029, and the notification period for sponsors of existing patient-matched medical devices is also expected to be extended, from 25 August 2022 to 1 November 2024.
Once extended, sponsors could still qualify for the transition if they then notify the TGA before 1 November 2024. They could then continue to supply those patient-matched medical devices but would need to apply for ARTG inclusion before 1 July 2029.
This transition extension primarily relates to those devices which were previously considered ‘custom-made’ medical devices, and which were exempt from entry in the ARTG.
What Devices are not Affected?
The transition does not apply to applications for any new kinds of devices, which did not qualify for the transition period. They must continue to be lodged at the new higher classification. This has been in place since 25 November 2021 and has not changed.
The transition also does not apply to the following types of devices:
- Active Implantable Medical Devices being re-classified from Class AIMD to Class III
- Software medical devices (unless they are software for therapy with diagnostic function)
The transition deadline of 1 November 2024 still applies to these devices.
How Can We Assist?
If you have AIMD products or software devices that need to be re-included in the ARTG due to the classification changes, there is still enough time to submit an ARTG application before the end of the transition period on 1 November 2024.
However, if you need to first apply for a TGA Conformity Assessment certificate before being able to lodge the ARTG application, time is running out! TGA processing times for Conformity Assessment certificates are typically 12-18 months, so applications need to be submitted as soon as possible in order to meet the transition deadline.
Commercial Eyes can assist manufacturers/sponsors who still need to meet the transition deadline of 1 November 2024.