Guidance has been released by Therapeutic Goods Administration (TGA) Australia to assist applicants seeking designation for priority review of either TGA conformity assessment, or inclusion in the Australian Register of Therapeutic Goods (ARTG) of a medical device.
A ‘front-of-queue’ priority throughout the relevant assessment process will be allocated to applications that are successful in obtaining a priority review designation. Business processes associated with applications for conformity assessment, and inclusion on the ARTG for medical devices are included.
After six months, designation decisions lapse, unless TGA receives an application for either TGA conformity assessment or ARTG inclusion during this time.
To gain Priority Review designation, medical devices must meet all three of the following criteria:
- Serious condition – the intended purpose of the new device is the monitoring, treatment, prevention or diagnosis of a life threatening or seriously debilitating condition; and
- Unmet need
- no medical devices with that intended purpose are of a kind included in the Register, or
- if one or more medical devices with that intended purpose are of a kind included in the Register (the existing devices) – there is substantial evidence demonstrating that the safety or performance of the new device when used for that intended purpose provides a significant improvement compared to the existing devices; and
- Breakthrough technology OR clinical advantage OR public health (in vitro device only) – at least one of the following applies to the new device:
- the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage over existing technology; or
- there is evidence that the device offers a major clinical advantage over existing alternatives included in the Register; or
- the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.
To view the TGA guidance on priority review designations for medical devices (including In Vitro Diagnostics), please click here.