Jun 22, 2021

When Australia’s Therapeutic Goods Administration (TGA) released its fee schedule for the 2020-2021 fiscal year, it announced a significant discount for listing medical devices to the Australian Register of Therapeutic Goods (ARTG) that were included on the Prostheses List. This measure was intended to help counter the impact of elective surgery cancellations that occurred due to the COVID-19 pandemic. The TGA clarified at the time that the discount would only apply for the duration of one year.

Forthcoming fee schedule for new fiscal year will not include ARTG listing discount

With the 2021-2022 fiscal year about to commence, the TGA has emailed stakeholders a confirmation that the discount for listing medical devices on the Prostheses List will no longer be available as of July 1, 2021. The following table, based on one included in the email, offers a comparison of the ARTG listing charges under the expiring discount and those that will apply starting on July 1:

Included medical device class

FY 2020-2021

FY 2021-2022

Class IIa

$470

$950

Class IIb

$470

$950

Class III

$600

$1,210

Class AIMD

$600

$1,210

The email further notes that the TGA will issue invoices for annual fees covering the new fiscal year in the first week of August; these are to be paid in full by September 15, 2001. A detailed fee schedule and related information will be published on this page in the near future.

More resources on Australian medical device regulation from Emergo by UL:

Author

  • Timothy Herr

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