Request a reduced medical device assessment fee

The below explains when medical device assessment fees may be reduced, who may be eligible, and how to request an abridged assessment.

It applies to application audits and conformity assessments for medical devices, including in vitro diagnostic (IVD) medical devices.

Key points

• Application fees cannot be reduced.
• Applicants should always be prepared to pay the full assessment fee. 
• Assessment fees may be reduced in limited circumstances.
• Requests must be submitted before an assessment invoice is issued.
• Reduced fees are only available where legislation allows and where the TGA can undertake an abridged assessment.
• Fee reductions are at the TGA's discretion
• Requests for reduced assessment fees or abridged assessments are considered case-by-case and may be approved in circumstances not specifically described below.
• Decisions about reducing (or not reducing) an assessment fee are not "initial decisions" under the Act and are therefore not reviewable under section 60.

When assessment fees may be reduced

Assessment fees may be reduced under Regulations 9.6 and 9.7 of the Therapeutic Goods (Medical Devices) Regulations 2002.

Public health grounds (Regulation 9.6)

Assessment fees may be reduced where:

• the device is important to public health, and
• paying the full assessment fee would make supply commercially unviable.

You will need to provide evidence of:

• the public health need for the device
• expected sales volumes
• profit margins
• financial viability

A reduction under Regulation 9.6 is fixed at 70% of the scheduled assessment fee.

Abridged assessments (Regulation 9.7)

Assessment fees may be reduced where information is available that allows the TGA to undertake a shorter assessment.

This may include:

• previous TGA assessments
• assessments completed by comparable overseas regulators
• audit reports or assessment reports that reduce the amount of work required by the TGA

Assessment fees can only be reduced where the assessment effort required by the TGA is reduced.

Fees that cannot be reduced

Fee reductions do not apply to:

• application fees
• supplementary audit fees
• device testing fees
• assessment fees for medicinal components of devices.

Request a reduced assessment fee

Requests must be submitted before an assessment invoice is issued.

For every application include the:

• application ID;
• submission ID;
• device name
• UPI information (if applicable)
• the reason you believe the assessment can be abridged
• supporting evidence and documentation.

Requests are considered during preliminary assessment. If approved, the reduced fee will be applied before invoicing.

Assessment fees

Assessment fees apply to:

• application audits
• conformity assessments

Current fees are available on the Schedule of fees and charges page.

Application audits

Assessment fees for mandatory application audits may be reduced where multiple applications:

• are submitted together, and
• share common technical documentation or clinical evidence.

In these circumstances, the TGA will generally charge:

• the full assessment fee for one application, and
• 40% of the full assessment fee for each additional application.

Conformity assessments

The full conformity assessment fee generally applies unless sufficient evidence supports an abridged assessment.

Manufacturers with an appropriate approval or certification from a comparable overseas regulator can apply to the TGA using that evidence and often do not need to apply for a TGA conformity assessment certificate. However, if there are classification differences between Australia and the other country, or if the manufacturer has been audited under the Medical Device Single Audit Program (MDSAP) and needs product assessment by the TGA, they should review the evidence requirements.

The extent of any fee reduction depends on the quality, scope and relevance of the evidence provided.

Product certificates (design examinations)

Fee reductions may apply where fewer assessment activities are required.

For non-IVD devices, assessment effort is based on the number of specialist component assessments required.

For IVD medical devices, assessment effort is based on the number of performance characteristics requiring assessment.

Quality management system (QMS) certificates

The TGA may abridge QMS assessments where evidence is available from comparable overseas regulators or assessment bodies.

Depending on the evidence provided, the TGA may:

• conduct a desk-based review instead of an onsite audit
• reduce the amount of documentation requiring review
• rely on recent audit reports

The final fee depends on the assessment work required and is determined case-by-case.