Reminder: From 25 November 2021, sponsors of Class IIb spinal fusion implantable medical devices need to provide the TGA with the name of their device recorded in their ARTG entry. You can do this by accessing the new Class IIb product name variation form in your TBS portal. Once you have notified the TGA, you will need to wait 20 working days before you can import, supply, or export your device. To ensure continued supply of your device, notifications should be made before 27 October 2021.
The purpose of this guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements.
From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:
- more detailed assessment of the manufacturer’s quality management systems and assessment of technical documentation related to each device
- conformity assessment documents demonstrating procedures appropriate for their classification
- a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence.
The classification of your spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements.
Contents
- About this guidance
- Background
- Devices being reclassified from Class IIb to Class III
- Examples of devices being reclassified to Class III
- Spinal disc replacement implants - not intended to fuse vertebral bodies
- Anatomic facet replacement system (AFRS)
- Interspinous process spacer
- Spinal fusion implantable devices will remain Class IIb
- Examples of spinal fusion implantable devices
- Examples of devices being reclassified to Class III
- What you need to do
- Medical devices included in the ARTG prior to 25 November 2021
- Applications to include a medical device in the ARTG lodged before 25 November 2021
- Cancelling your ARTG inclusion
- Applications to include a new medical device on or after 25 November 2021
- Notifying the TGA that you need to reclassify a device
- Submitting an application for a Class III device
- Timeframes for applications for ARTG inclusion
- Mandatory audits
- Class IIb applications/entries
- Devices supplied under the ARTG entry
- Notifying the TGA - Class IIb spinal fusion devices
- Patient information leaflets and implant cards
- Amendments to Prostheses List
- If your inclusion application is not successful
- When you must cease supply using your old ARTG entry