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Priority review designations medical devices (including IVDs)

Version 1.2, August 2018

23 August 2018

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Criteria for Priority Review designation

To gain Priority Review designation, medical devices must meet all three of the following criteria:

  1. 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

  2. Unmet need


    1. no medical devices with that intended purpose are of a kind included in the ARTG, or
    2. if one or more medical devices with that intended purpose are of a kind included in the ARTG (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
  3. Breakthrough technology OR clinical advantage OR public health (in vitro device only) - at least one of the following applies to the new device:
    1. the new device is a breakthrough technology and there is evidence that it offers a major clinical advantage* over existing technology; or
    2. there is evidence that the device offers a major clinical advantage* over existing alternatives included in the ARTG; or
    3. the new device is an IVD medical device and its early availability in Australia will result in a major public health benefit.

*Engineering or pre-clinical evidence is insufficient on its own; there must be evidence of a major clinical advantage.

Demonstrating eligibility

Consider whether the medical device meets the three eligibility criteria of serious condition, unmet needs, and major therapeutic advantage. You'll need to make a concise, persuasive argument against all three criteria.

Criterion 1 - Serious condition

Identify the severity of the disease or condition, based on objective and quantifiable medical information and analysis.

You need to justify the severity of the disease in Australia (i.e. its seriously debilitating or life-threatening nature), based on objective and quantifiable medical information.

Your designation application must justify the:

  • life-threatening nature of the disease or condition based on figures of mortality and life expectancy in Australia
  • seriously debilitating nature of the condition based on morbidity over the course of the disease and its consequences on patients' day-to-day functioning

The serious debilitation or fatal outcome should be a prominent feature of both the target disease or condition and the manufacturers intended purpose of the medical device, i.e. affect an important portion of the target population. The intended purpose is the proposed intended purpose for ARTG inclusion, based on the proposed intended purpose at the time of the designation application.

Criterion 2 - Unmet need

Discuss the current 'state of the art' in treatment of the condition, and how your device will help treat affected patients. Describe how, and to what extent, your medical device is expected to fulfil a major or urgent unmet medical need.

You should provide:

  • Details of any relevant similar medical device(s) and a brief analysis of similarities and differences between your device and similar devices; or
  • A declaration that there are no similar medical devices in the ARTG with the same intended purpose, along with a brief summary of searches completed to establish this.

Document the expected patient population and present evidence that your medical device will provide an advantage over existing available treatment(s) by addressing whichever is relevant:

  • Improved performance for the population relevant to the intended purpose; or
  • A better safety profile for the population relevant to the intended purpose; or
  • Treats an otherwise excluded patient population.

Criterion 3 - Breakthrough technology / clinical advantage / public health

Provide a succinct summary of the available evidence with respect to:

  • the magnitude of the demonstrated improvement in safety and/or performance
  • the impact on patient outcomes taking into account both safety and performance
  • the magnitude of the advance in relation to other medical devices in the ARTG. Where no product is in the ARTG, the comparison should occur against the standard of care.

To meet criterion 3, your new medical device needs to meet at least one of the following:

i) Breakthrough technology with major clinical advantage:

Provide summary demonstrating novelty and advance in the treatment associated with the use of your device.

The clinical advantages may include, for example, reduction in the need for hospitalisation, improved quality of life, better effectiveness of the treatment, etc.[1]

The comparison with the existing treatments for the same indications should include:

  • Specific examples of improvements against existing available treatments (based, for example, on summary of design analysis and/or studies available); and
  • Best quality clinical data available documenting health benefits to the indicated patient population.
ii) Clinical advantage over existing alternatives included in the ARTG:

The justification for this point should address one or more of the following:

  • Improved performance for the population relevant to the intended purpose; or
  • Better safety outcomes for the target population.
Safety aspects

In the case of novel medical devices, it might not be practicable to demonstrate a magnitude of improvement based on established safety and performance endpoints. You should still however clearly outline any actual safety and performance issues of the existing treatments for the condition you state your device will be used for, and explain how your new medical device will counteract these safety and performance issues, and support your argument by the best evidence available (including summaries of the study reports available).

iii) FOR IVDS ONLY: Early availability in Australia will result in a major public health benefit

Your application should include justification on how the IVD will improve the health of the Australian public. We expect that your justification will be supported by the following:

  • Documentation of the improved sensitivity and specificity of the IVD compared to existing IVDs in the ARTG, including magnitude of improvements and endpoints, predictive values and/or likelihood ratios.
  • Estimated patient population that will benefit from the improved diagnosis and/or treatment.

For the claim of improved performance or safety, we will evaluate whether there is a high probability that the Australian population will experience a clinically relevant benefit. Therefore, your reasoning should be based on the best evidence available, including summaries of full study reports and respective analysis.

The evidence must be considered in light of both the particular characteristics of the condition (number of affected patients; transmission of the disease) and other available diagnostics (or methods of treating the identified condition/preventing spread).


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  1. Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (pdf,800kb)*

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