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Medical devices (including IVDs) priority applicant designation notice

14 July 2021

What is designation?

Designation allows the TGA to determine if a Medical Device is eligible via the priority review pathway.

The sponsor of the Medical Device must submit an application for designation to allow the TGA to determine whether the medical device meets the eligibility criteria. These criteria ensure only products providing the most benefit to patients are eligible. Eligibility criteria for priority review determination is published on our website.

A priority applicant designation does not mean that the Medical Device has been approved and registered in the Australian Register of Therapeutic Goods (ARTG).

To register after obtaining a designation, the sponsor must lodge an application for registration. These applications are subject to a rigorous evaluation process resulting in a TGA decision on whether the Medical Device should be registered on the ARTG. Details of registered products approved for supply in Australia can be obtained by searching the ARTG.

Priority reviews remain in force for a period of 6 months from the initial effective date.

Details of Medical Devices that have an approved priority review designation, are listed below.

Approved designations for Medical Devices (including IVDs)

No results.