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Reduction of assessment fees for medical devices

30 November 2011

TGA guideline for reduction of medical device assessment fees

A new TGA guideline about reduction of assessment fees for medical devices has been developed with the aim of:

• Simplifying the guidance used by TGA staff to determine if an abridged assessment and reduction of assessment fees is possible and appropriate.
• Making the TGA process of determining the level of reduced assessment fees for medical devices more consistent and transparent to applicants.

The guideline does not prescribe exact reduced assessment fee amounts for different circumstances that allow for an abridged conformity assessment. Instead, it describes scenarios where an abridged assessment may be possible and provides a description of how a reduced assessment fee may be determined by the TGA financial delegate.

The guideline also incorporates guidance on the reduction of assessment fees for application audits of medical devices, as this is done under the same regulation as that for reducing conformity assessment fees.

The guideline does not cover assessment fees for IVDs, as this has been previously agreed with the IVD industry as part of the transition arrangements for the new IVD framework, and is the subject of a separate guidance document: Fees and charges for IVD medical devices.

Reduction of assessment fees for medical devices

Guidelines for reducing assessment fees for application audits and conformity assessments of medical devices (other than IVDs)

Version 1.1, November 2011

About the Therapeutic Goods Administration (TGA)

• The TGA is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.
• TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.
• The work of the TGA is based on applying scientific and clinical expertise to decision-making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices.
• The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.
• To report a problem with a medicine or medical device, please see the information on the TGA website.

Copyright

© Commonwealth of Australia 2011

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <tga.copyright@tga.gov.au>.

Version history

Version	Description of change	Author	Effective date
V1.0	First version of this document. Combined elements of previous internal TGA business rules.	Office of Devices Authorisation	6 October 2011
V1.1	Minor amendments for consistency, including clarification that the document does not relate to IVD medical devices.	Office of Devices Authorisation	21 November 2011

Contents

• Overview
  • Scheduled fees
    • Application fees
    • Assessment fees
  • Reduction of assessment fees
  • Important notes
• Application audits
• Conformity assessments
  • Process for requesting an abridged assessment
    • TGA process
  • Eligibility for abridged assessments
    • Quality system certificates
    • Product certificates
  • Possible level of reduced assessment fees

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Overview

The TGA is fully cost-recovered and collects its revenue primarily through annual charges, application fees, and assessment fees.

The Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) prescribes certain circumstances where assessment fees for medical devices may be reduced, including:

• reduction in assessment fees where supply of a medical device is in the interests of public health, and it would not be commercially viable if the full amount of the fee were paid (regulation 9.6); and
• reduction in assessment fees where information allows the assessment to be abridged (regulation 9.7).

Information about the fees and charges for medical devices can be found in Section 2 of the Australian Regulatory Guidelines for Medical Devices (ARGMD) available on the TGA website.

This guideline provides additional information about the eligibility requirements and procedures used by the TGA in order to determine whether assessment fees can be reduced for application audits and conformity assessment applications involving medical devices (other than IVDs).

This document does not cover applications for IVD medical devices, as this is the subject of a separate TGA guidance document: Fees and charges for IVD medical devices.

Scheduled fees

Schedule 5 of the medical devices Regulations specifies the various fees that apply to medical devices, including; application fees, notification fees, and assessment (or evaluation) fees.

Fees prescribed in Schedule 5 of the Regulations are subject to annual adjustment. The level of any reduced assessment fees shall also be adjusted annually in line with changes in the scheduled fees. The fees and charges currently applicable to medical devices are available on the TGA website.

Application fees

A summary of the relevant scheduled application fees for conformity assessment applications, and applications to include medical devices in the Australian Register of Therapeutic Goods (ARTG), are provided in the table below.

Legislative references for medical device application fees

Type of Application	Scheduled Fee Reference
Application to include medical device in the ARTG Different application fees apply to different classes of medical devices.	Schedule 5, Part 1, Item 1.5
Application for conformity assessment certificate Applicable to applications for new certificates, changes to certificates, or re-certification applications.	Schedule 5, Part 1, Item 1.1

Assessment fees

A summary of the relevant scheduled assessment fees for application audits and conformity assessments are provided in the table below.

Legislative references for medical device assessment fees

Type of Assessment	Scheduled Fee Reference
Application audit - Level 1 assessment	Schedule 5, Part 1, Item 1.13
Application audit - Level 2 assessment	Schedule 5, Part 1, Item 1.14
Conformity assessment – initial assessment Applicable to applications for new manufacturers, new medical devices (requiring design or type examination), or where previous conformity assessment certificates have since expired.	Schedule 5, Part 1, Item 1.9
Conformity assessment – assessment of changes Applicable to current conformity assessment certificates where a change to the device or QMS is required to be assessed.	Schedule 5, Part 1, Item 1.10
Conformity assessment – Review of QMS certificate Applicable to surveillance audits, and recertification applications, for current Schedule 3, Part 1, 4 or 5 certificates.	Schedule 5, Part 1, Item 1.2
Conformity assessment – Review of product certificate Applicable to a review of current Design Exam (Schedule 3, clause 1.6) or Type Exam (Schedule 3, Part 2) certificates, including recertification applications.	Schedule 5, Part 1, Item 1.3

Reduction of assessment fees

Assessment fees for medical devices may be reduced by the Secretary (or their Delegate) under certain circumstances, as provided for under regulation 9.6 and 9.7 of the Regulations.

Regulation 9.6 of the medical devices Regulations states that:

In order for this regulation to apply, the applicant must be able to clearly demonstrate that the supply of the medical device is in the interests of public health (as opposed to an individual's health, or the commercial interests of the company). If other similar devices are already available on the Australian market, it is unlikely that assessment fees would be reduced under this Regulation.

In order to consider the commercial viability of supplying the device, the applicant would be required to provide details of likely sales figures and profit margins. This regulatory requirement is only likely to be met for devices of low value and limited sales potential.

The level of fee reduction under Regulation 9.6 is fixed at 70%, and applies only to assessment fees.

Regulation 9.7 of the medical devices Regulations states that:

Regulation 9.7 of the medical device Regulations includes provisions for reduction of assessment fees for application audits and conformity assessments, where information is available that allows the assessment to be abridged.

The type of information that can be considered must relate either to the medical device, or to aspects of the conformity assessment procedures that have been applied to the medical device.

It may be possible for the TGA to lower the assessment fee according to the degree of regulatory assessment already undertaken, either by the TGA, or by a recognised conformity assessment body (e.g. European Notified Body).

The amount of any fee reduction under regulation 9.7 will be commensurate with the level of assessment required to ensure regulatory compliance, and applies only to assessment fees.

Important notes

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Application audits

An assessment fee is payable for each application that is required by the Regulations to be selected for auditing under regulation 5.3 (compulsory audits). Fees are not payable for other application audits that the TGA decides to conduct (non-compulsory audits).

There are different fees for Level 1 and Level 2 application audits. Details of the fees currently applicable are available on the TGA website.

Application audit assessment fees can be reduced where a sponsor has more than one medical device application able to be grouped with other similar device applications (within the TGA called a 'submission').

The procedure below must be followed by applicants to enable the reduction of fees to be considered. If these rules are not followed, the TGA will undertake a full assessment of an application at the scheduled fee.

Applications selected for an application audit will be eligible to be considered for a reduced assessment fee if:

• All the effective applications for inclusion are received on the same day (that is, the application fees are paid on the same day)
• All the applications are for the same medical device classification (that is, all Class III or all Class AIMD)
• A written request from the sponsor for reduced fees is electronically attached to each of the applications by the applicant. In particular, the written request must include:
  • A reference to each of the relevant application ID numbers to be considered for abridged assessment fees.
  • A statement from the sponsor that the standard supporting information package normally required for application audits is entirely common for all of the applications, and will allow an abridged assessment to be performed (except for labelling, instructions for use, or promotional material).
• The Manufacturer's Evidence used to support each of the device applications must be the same (that is, the devices in each application must be covered by the same certification).
• Applications are selected for a mandatory pre-market application audit as per section 41FH of the Act, and regulation 5.3 of the medical devices Regulations.

If all of the above conditions have been met, then:

• A full scheduled application audit assessment fee will apply to the first application in the group.
• A reduced assessment fee equivalent to 28% of the scheduled application audit assessment fee will be recommended to the Secretary for each of the other applications in the same group.
• Based on the information in each of the applications, and the written request for reduced fees from the sponsor, the delegate of the Secretary under regulation 9.7 will make a decision whether to reduce the amount of the assessment fees.
• The sponsor will be notified of the outcome of this decision at the time the supporting information is requested for the application audit. A statement of reasons shall be provided where the decision is not to reduce the assessment fees.
• An invoice for the total assessment fees to be paid shall be issued to the sponsor under separate cover.

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Conformity assessments

By default, the TGA will undertake assessment of an application at the full scheduled assessment fee. When submitting a conformity assessment application the applicant may request the TGA to consider an abridged assessment in order to reduce the assessment fees. In doing so, the applicant is required to provide sufficient additional information which could allow the TGA to abridge the assessment.

Where a request for abridgement of the assessment is made because the manufacturer and/or the device has been reviewed by another appropriate assessment body under equivalent regulatory requirements (e.g. a EU Notified Body under the MDD 93/42/EEC), information submitted in support of the application must include the applicable audit reports and/or product assessment reports issued by that assessment body.

Should the information provided not support an abridged assessment, a full assessment will be conducted and the scheduled fee will apply.

Where a Quality Management System (QMS) certificate has been issued by a recognised Canadian CMDCAS Registrar, abridgement of the QMS component (but not the product assessment) may be possible.

Process for requesting an abridged assessment

Written requests for abridgement and reduction of assessment fees must be made before the TGA issues an invoice for the assessment fees. For conformity assessments the requests may be included as part of the supporting information submitted to the TGA in response to the initial request for information.

The written request should include:

• a reference to the relevant submission ID number to be considered for reduced fees;
• the basis on which abridgement is being sought; and
• a statement that evidence to justify the request has been included in the supporting information.

Requests should be addressed to:

Head, Office of Devices Authorisation
Therapeutic Goods Administration
PO Box 100
Woden ACT 2606

When submitting information to support the application, the applicant must provide sufficient documentary evidence to support the request for an abridged assessment.

For example, if the manufacturer already holds full quality assurance and design examination certification from a European Notified Body under the MDD 93/42/EEC, then the applicant will need to submit copies of the certificates, as well as the Notified Body's supporting audit/assessment reports.

If sufficient documentary evidence is not submitted by the applicant, the assessment will not be able to be abridged, and the Delegate will not be able to apply a reduced assessment fee under regulation 9.7.

TGA process

The process of considering an abridged assessment, and the invoicing of assessment fees, is summarised below:

1. Applicant submits electronic application via TGA eBusiness Services website (may attach written request for an abridged assessment).
2. TGA requests initial supporting information from applicant.
3. Applicant submits requested supporting information, including a copy of the written request for an abridged assessment, and sufficient documentary evidence in support of that request.
4. TGA conducts a 'pre-assessment' of the application, and agrees on an assessment plan for the application. The assessment plan will include consideration of any request for an abridged assessment.
5. If an abridged assessment can be accommodated, a memo recommending a reduction of fees is prepared and sent to the Delegate to the Secretary for consideration.
6. If the Delegate to the Secretary agrees that the TGA has sufficient information to allow an abridged assessment, they will make a determination on an appropriate reduced assessment fee using this document as a guide.
   If the Delegate to the Secretary does not agree to a request for an abridged assessment, the applicant will be notified.
7. The TGA sends a notification letter to the applicant informing them of the proposed level of assessment and associated fees, and arranges for an invoice to be sent to the applicant for either the full assessment fee, or the reduced assessment fee as determined by the Delegate to the Secretary (if applicable).

Eligibility for abridged assessments

Quality system certificates

The scenarios relating to a manufacturer's QMS that may allow an abridged assessment to be conducted by the TGA are described below.

The manufacturer plans to implement a substantial change to the quality management system under a Schedule 3, Part 1, 4 or 5 conformity assessment certificate; and The incorporation of the change in the respective conformity assessment certificate does not require a full assessment by the TGA.

The manufacturer holds current EC certification issued by a Notified Body under an EU Medical Devices Directive (93/42/EEC or 90/385/EEC), or ISO13485 certification issued under CMDCAS by a Health Canada recognised registrar; and The assessment undertaken by the assessment body incorporated the same elements of an assessment required for a Schedule 3, Part 1, 4 or 5 conformity assessment certificate; and An initial assessment or surveillance audit has been undertaken within the previous 12 months.

The manufacturer has been selected for a surveillance audit of a Schedule 3, Part 1, 4 or 5 conformity assessment certificate by the TGA; and The manufacturer holds current EC certification issued by a Notified Body under an EU Medical Devices Directive (93/42/EEC or 90/385/EEC), or ISO13485 certification issued under CMDCAS by a Health Canada recognised registrar; and An assessment has been undertaken by the assessment body within the previous 12 months; and That assessment incorporated the same elements as a TGA surveillance audit.

The manufacturer holds current EC certification issued by a Notified Body under an EU Medical Devices Directive (93/42/EEC or 90/385/EEC), or ISO13485 certification issued under CMDCAS by a Health Canada recognised registrar; and The manufacturer plans to implement a substantial change to the quality management system under a Schedule 3, Part 1, 4 or 5 conformity assessment certificate; and The change has been satisfactorily assessed by the assessment body.

The manufacturer holds conformity assessment certification under Schedule 3 Part 1, clause 1.6, Part 4, or Part 5 of the Regulations; and The manufacturer applies for changes to the content of a certificate that require little or no assessment by the TGA (e.g. change to name of manufacturer only).

The manufacturer holds a QMS certificate issued under the Australia-Canada MoU by a participating Canadian Registrar. The MoU QMS certificate will be recognised by the TGA, and taken into consideration as part of an application for a Schedule 3, Part 1, 4 or 5 conformity assessment certificate. An initial on-site audit of the manufacturer's QMS will not be undertaken by the TGA where a Canadian MoU certificate has been issued.

In each of these circumstances the TGA may be able to abridge the assessment of the manufacturer's QMS to allow:

• a reduced review of the technical files for each kind of medical device, or
• a desk audit of the QMS documentation (instead of an on-site audit).

The level that a QMS assessment is able to be abridged is dependent on many factors, including:

• the existence, and content, of audit reports from other assessment bodies, and
• whether an on-site audit has been undertaken recently.

Scenarios other than those described above may also allow an abridged assessment of the manufacturer's QMS to be conducted, however this will be reviewed on a case-by-case basis and will need to be supported by a detailed justification from the manufacturer.

Product certificates

The scenarios relating to a medical device covered by a Design Exam or Type Exam certificate that may allow an abridged assessment to be conducted by the TGA are described below.

The manufacturer holds current EC certification issued by a Notified Body under an EU Medical Devices Directive (93/42/EEC or 90/385/EEC), or a Canadian product licence issued by Health Canada; and The assessment undertaken incorporated the same elements of an assessment required for a conformity assessment certificate under clause 1.6 (Design Exam) or Part 2 (Type Exam) respectively.

The manufacturer plans to implement a substantial change to the design of the device under a Schedule 3, clause 1.6 or Part 2 conformity assessment certificate; and The incorporation of the design change does not require a full assessment by the TGA.

The manufacturer applies for a Part 2 (Type Exam) certificate and holds a relevant Type Test certificate; and The Type testing has been performed against a recognised Medical Device Standard; and Testing has been performed by a testing laboratory with accreditation by NATA or other IAF member.

The manufacturer submits an initial application for Schedule 3, clause 1.6 (Design Exam) certificates for different kinds of Class III/AIMD medical devices; and One kind of device in the application is subject to full design examination; and The other devices in the application are similar enough for a concurrent assessment to be conducted.

The manufacturer submits an initial application for a Schedule 3, clause 1.6 (Design Exam) certificate; and The kind of medical devices in the application are similar enough to a device previously subject to full design examination by the TGA.

The manufacturer holds conformity assessment certification under Schedule 3, clause 1.6 (Design Exam) or Part 2 (Type Exam); and The manufacturer applies for changes to the content of a certificate that require little or no assessment by the TGA (e.g. change to name of products only).

In each of these circumstances the TGA may be able to abridge the assessment of the design of the kind of medical device to allow:

• a reduced examination of the design dossier for each kind of medical device (Design Exam), or
• a reduction in the type testing required, or the assessment of the type testing reports (Type Examination).

The level that a product assessment is able to be abridged is dependent on many factors, including:

• the existence, and quality, of technical assessment reports from the assessment body,
• the complexity of the technology involved, and
• the similarity of the device with previously TGA assessed devices.

Scenarios other than those described above may also allow an abridged assessment of the medical devices to be conducted, however this will be reviewed on a case-by-case basis and will need to be supported by a detailed justification from the manufacturer.

Possible level of reduced assessment fees

The tables below indicate the minimum assessment fee level that may be considered for different conformity assessment certificate applications, in cases where an abridged assessment is considered appropriate.

Minimum assessment fee levels for Schedule 3, Part 1, 4 or 5 certificates (initial or change applications)

		Level of QMS Review
		No audit (desk or on-site)	Desk audit or on-site audit
Level of Technical File Review	None	No assessment fee	One third (1/3) the value of the scheduled fee
	Minor	One third (1/3) the value of the scheduled fee	Two thirds (2/3) the value of the scheduled fee
	Major	Two thirds (2/3) the value of the scheduled fee	Full scheduled fee applies

Example: For an application for an initial Schedule 3, Part 1 certificate, where the technical file review is abridged to a minor level, and an on-site QMS audit is undertaken, an assessment fee equal to two thirds of the full Schedule 3, Part 1 assessment fee may be applied.

Minimum assessment fee levels for Schedule 3, clause 1.6 (Design Exam) or Part 2 (Type Exam) certificates (initial, change or recertification applications)

Level of Review of Product Design	None	No assessment fee
	Low	One third (1/3) the value of the scheduled fee
	Medium	Two thirds (2/3) the value of the scheduled fee
	High	Full scheduled fee applies

Example: For an application for a change to a Schedule 3, clause 1.6 (Design Examination) certificate, where the level of the design review is abridged to a low level, an assessment fee equal to one third of the full Schedule 3, clause 1.6 assessment fee may be applied.

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