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
Class IIb spinal fusion devices will need to have specific information in the ARTG entry about the devices that are supplied under the ARTG entry. This includes product names of all devices under each ARTG entry.
The classification of your spinal implantable medical device will determine the safety and performance requirements to be demonstrated to meet regulatory requirements.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.