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On 25 November 2021, the reclassification of certain medical devices came into effect. To continue to supply affected devices through transitional arrangements you must have notified the TGA by 25 May 2022 that you have an inclusion to be reclassified.
The submission of a transition notification for the device(s) does not commit sponsors to a pathway for reclassification if it is later determined the device is not required to be reclassified.
Our "What classification is my medical device?" tool has been updated with the reclassification changes and can assist in determining the classification of a medical device if sponsors are unsure if their devices will require reclassification.
Transitional devices must apply to be included in the ARTG at the new classification before the transition deadline to ensure uninterrupted supply.
In November 2023, regulatory amendments have been made to extend the transition deadline for some transitional devices to 1 July 2029.
The updated transition deadline is summarised in the table below.
| Reform | Transition deadline for existing ARTG entries |
|---|---|
| Active medical devices for therapy with diagnostic function (including any related software) | 1 July 2029 |
| Spinal implantable medical devices (motion preserving) | 1 July 2029 |
| Devices used in direct contact with the heart, central circulatory system, or central nervous system (including any related software) | 1 July 2029 |
| Devices that administer medicines or biologicals by inhalation (including any related software) | 1 July 2029 |
| Devices that are substances introduced into the body via body orifice or applied to the skin (including any related software) | 1 July 2029 |
Project overview
The re-classification of certain medical devices came into effect on 25 November 2021. They are outlined in the table below.
| Reform | Old classification | Revised classification |
|---|---|---|
| Active medical devices for therapy with diagnostic function | IIa or IIb | III |
| Spinal implantable medical devices (motion preserving) | IIb | III |
| Devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system | IIa | III |
| Medical devices that administer medicines or biologicals by inhalation | I or IIa | IIa or IIb |
| Active implantable medical devices (AIMD) | AIMD | III |
| Medical devices that are substances introduced into the body via body orifice or applied to the skin | I or IIa | IIa, IIb or III |
Applications for medical device inclusions submitted on or after 25 November 2021 must be submitted according to the new classification rules.
Annual charge waiver or refund
From 1 July 2023, sponsors will be eligible for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification.
Transitioning medical devices subject to reclassification will be eligible for a refund or charge waiver at any time during a charge year if:
- They are included twice in the ARTG under two different classifications as listed in the table above (the ‘Old classification’ and ‘Revised classification’),
- The ARTG entry under the ‘Old classification’ does not include any non-transitioning devices, and
- The ARTG entry under the ‘Old classification’ is listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules (previously known as the Prostheses List).
If you are sponsor of a transitioning medical device eligible for annual charge waver or refund, you will need to complete and submit the application form.
Useful guidance
- Reclassification of spinal implantable medical devices
- Reclassification of devices used in direct contact with the heart, central circulatory system (CCS), or central nervous system
- Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin
- Reclassification of Active Implantable Medical Devices (AIMD)
- Reclassification of medical devices that administer medicines or biologicals by inhalation
- Reclassification of active medical devices for therapy with a diagnostic function
Background
In early 2019, we undertook public consultations on proposals to reclassify certain categories of medical devices so that they align, wherever possible, with the changes being introduced in European Union (EU) medical devices framework.
The response of stakeholders broadly supported the aligning the Australian medical devices framework with the EU framework.
The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 were made on 12 December 2019, which amends the Therapeutic Goods (Medical Devices) Regulations 2002 to reclassify six categories of medical devices.
We have continued to consult regarding the proposed changes to reclassification, prior to considering regulatory amendments for this category of devices.
On 23 July 2020, the Governor-General in Council made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.
The Australian Medical Device Regulations have been amended to delay implementation of some reclassification reforms from 25 August 2020 to 25 November 2021.
Stakeholders were consulted through rounds of public consultations from April 2019 to July 2021 Feedback on proposed amendments helped us identify potential issues, tailor stakeholder engagement programs and refine amendments.