This guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.

All spinal implantable medical devices are currently classified as Class IIb medical devices under the Therapeutic Goods (Medical Devices) Regulations 2002 but from 25 November 2021, implantable devices that are intended to be a motion-preserving device for the spine will be reclassified from Class IIb to Class III.

The action to be taken by the sponsor of a spinal implantable medical device to comply with the new regulations will depend on the status of the product.
 

Medical devices included in the Australian Register of Therapeutic Goods (ARTG) prior to 25 November 2021:

If the sponsor has a Class IIb medical device inclusion in the ARTG with a start date before 25 November 2021, transitional arrangements are in place to ensure that sponsor can continue to supply the device while applying for it to be included in the ARTG as a Class III medical device. To continue to supply device sponsor must:

• Notify the TGA before 25 May 2022 that the sponsor has an inclusion that will need to be re-classified.

• Submit an application for the device to be included in the ARTG as a Class III medical device before 1 November 2024.
 

Applications to include a medical device in the ARTG lodged before 25 November 2021:

For a Class IIb device inclusion in the ARTG lodged before 25 November 2021, the application will be assessed and the device will be included in the ARTG as a Class IIb device under the old classification rules. To be eligible for the transitional arrangements to reclassify the device as a Class III device, the sponsor must:

• Notify the TGA about ARTG inclusion that will need to be reclassified by whichever is the later date: – before 25 May 2022 – within 2 months of the start date of the ARTG entry.

• Submit an application for the device to be included in the ARTG as a Class III device before 1 November 2024.
 

Canceling ARTG inclusion:

If the sponsor does not notify the TGA before 25 May 2022 or within two months of the start date for ARTG entry (whichever is the later date) of intention to apply for the device to be included in the ARTG as a Class III device, the sponsor will no longer be eligible for the transitional arrangements. Sponsor should:

• Cease supply of the device from 25 May 2022

• cancel ARTG inclusion before 25 May 2022.

If the sponsor notifies the TGA of the device before the due date but do not submit an application for a Class III ARTG inclusion before 1 November 2024, the sponsor must:

• cease supply of the device from 1 November 2024

• cancel the ARTG inclusion.
 

Applications to include a new medical device on or after 25 November 2021:

Any application for inclusion of a new device intended to be a motion-preserving device for the spine that is not yet included in the ARTG submitted to the TGA on or after 25 November 2021 must be submitted as an application for a Class III medical device.
 

Notifying the TGA about reclassifying a device

To notify the TGA about an ARTG inclusion for a Class IIb spinal implantable medical device that needs to be reclassified, the sponsor will need to fill in the online form on Consultation Hub: https://consultations.health.gov.au/tga/spinal-implantable-medical-devices/

The form will be available until 24 May 2022. The information that should be provided includes the existing ARTG number, current classification and new classification. For devices that will be newly classified as Class III medical devices, Unique Product Identifier (UPI) for each device and/or variant should also be provided.
 

Timeframes for applications for ARTG inclusion

In order to continue supplying devices, the sponsor must submit an application for a Class III inclusion in the ARTG before 1 November 2024.

If the sponsor has submitted the application before this date, but it has not yet been finalized by the TGA, sponsor will be able to continue to supply devices using Class IIb ARTG entry until a decision is made about Class III application.

• Sponsor must use and submit a Class III application form electronically through the TGA Business Services (TBS) client’s portal.

• Sponsor will need to submit appropriate conformity assessment documentation in support of the application.  Class III applications for ARTG inclusion must be accompanied by appropriate conformity assessment documentation in order to pass the preliminary assessment. If the sponsor does not pass the preliminary assessment, the application will be refused and will not be able to transition the device to the new classification.

• Sponsor will need to pay the relevant application fee and audit assessment fee.

• Sponsor can request abridgment of the audit assessment (including requests to abridge the level of audit if appropriate).
 

Mandatory audits

If Class III application of the sponsor is not supported by MDR, TGA, or AU CAB certification, the application will be selected for a compulsory application audit. Compulsory application audits attract an audit assessment fee and require the submission of additional information, which may include clinical evidence to support the safety and performance of the device. Further, Class IIb spinal implantable devices that are not supported by MDR, TGA, or AU CAB certification will also need to undergo a mandatory audit for applications submitted on or after 25 November 2021. These audits will include an assessment of clinical evidence.
 

If the inclusion application is not successful

If the inclusion application to the transition of the device to the new classification is not successful, the sponsor will be notified of the decision in writing and will be provided the reasons for the decision. If the sponsor is not satisfied with this decision, may request reconsideration of this initial decision under section 60 of the Therapeutic Goods Act 1989 within 90 days of the decision and if not satisfied with the reconsideration (reviewable decision), may apply to the Administrative Appeals Tribunal or the court.
 

When sponsor must cease supply using old ARTG entry

 If the sponsor does not meet obligations under the transitional arrangements, should cease supply of the devices that would be considered Class III medical devices.

The following table outlines the circumstances and timeframes: