Jul 1, 2020

Australia’s Therapeutic Goods Administration (TGA) published its new fee schedule for the upcoming year and announced delays to a series of regulatory reforms.

2020-21 fee schedule released

The TGA’s fee schedule for the 2020-2021 fiscal year, which begins on July 1, includes the general 1.95% increase that had been identified in a proposal published in January. The schedule also features a new tiered fee structure for consent to import, supply, or export non-compliant devices (including IVDs).

One noteworthy addition is a discounted schedule of annual Australian Register of Therapeutic Goods (ARTG) listing fees for devices on the July 2020 Prostheses List, which is applicable for this fiscal year only due to the impact of elective surgery cancellations during the COVID-19 pandemic. This reflects a discount of 50% from the standard annual ARTG fees. There is no need for medical device companies to submit a request for the discount to the TGA; instead it will be automatically applied to eligible ARTG entries.

The IVD variation application fee appears to have been omitted from the schedule, which may have been an oversight. If so, it has likely increased to AUD $470, in line with the medical device variation application fee.

Learn how other device markets are responding to COVID-19.

Proposed delay of various regulatory reforms             

The Australian Government is proposing to delay the commencement of a number of planned medical device regulatory reforms. This proposal reflects the challenges identified by the medical device industry and healthcare professionals as they have focused on the COVID-19 crisis.

The Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 would be amended to delay implementation of the reforms from August 25, 2020 to:

Amendments to the Essential Principles in the Australian Medical Device Regulations and their implementation are also proposed to be delayed for up to two years after the commencement of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). They would thus likely go into effect in May 2023, or May 2024 if IVDR implementation ends up being delayed for one year.

The delay to the amendments is intended to provide time for industry to adjust to the EU regulations and to allow consideration of similar changes in the Australian context in order that the transition in Australia may be implemented effectively.

Related resources on Australian medical device regulation:

Author

  • Timothy Herr

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