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Reclassification of Spinal Implantable Medical Devices


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:

                     IfSponsor must
Sponsor not notified the TGA that the device needs to be reclassified before 25 May 2022, or within two months of inclusion of your device under the old classification rules (whichever is the later date).Cease supply of the devices from 25 May 2022 or the date that is 2 months after the start date of ARTG entry (whichever is the later date).
Sponsor not submitted an application for inclusion in the ARTG to transition the device to the correct classification before 1 November 2024.Cease supply of the devices from 1 November 2024.
Application for ARTG inclusion of the device with the correct classification is unsuccessful.Cease supply of the device from the time notified of the outcome of the application.