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Reduction of assessment fees for medical devices

Version 3.0, November 2015

30 November 2015

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3. 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. an EU Notified Body under the MDD 93/42/EEC or IVDD 98/79/EC), detailed evidence of such third party assessment must be provided. The information submitted in support of the application must include the applicable audit reports and/or product assessment reports issued by that assessment body; the quality of such evidence will determine whether fee reduction is possible on this basis.

Should the TGA determine that the information provided does not support an abridged assessment, a full assessment will be conducted and the scheduled fees 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.

3.1 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, Devices Authorisation Branch
      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 or IVDD 98/79/EC, 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, or does not contain adequate detail, 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.

3.1.1 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.
  2. Applicant submits supporting information, including the written request for an abridged assessment, and sufficient documentary evidence in support of that request.

Please note:

  • Applications for new certificates to recertify a device or manufacturer, where a previous TGA certificate is expiring, do not require a request for an abridged assessment.
  • The Secretary will already have information, from the assessment conducted for the previous certification period, which should allow the assessment to be abridged and the corresponding fees to be reduced.
  • A fee reduction will automatically be considered for these recertification applications.
  1. 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.
  2. If an abridged assessment can be accommodated, a memo recommending a reduction of fees is prepared and sent to the Delegate of the Secretary for consideration.
  3. If the Delegate of 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 of the Secretary does not agree to a request for an abridged assessment, the applicant will be notified as per the following step.
  4. 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).

Please note:

  • Any reduction of assessment fees remains at the discretion of the Delegate of the Secretary for the purposes of regulation 9.7.
  • The amount of any reduced assessment fees is not negotiable.
  • Once the assessment fees have been invoiced, the fees are due and payable according to the instructions on the invoice.
  • The TGA cannot consider abridged assessments, or reduction of assessment fees, for Schedule 3, Part 3 Verification conformity assessment certification.
  • Additional assessment fees may be incurred if supplementary assessment work is required during the application that was not initially forecast.

3.2 Eligibility for abridged assessments

3.2.1 Quality system certificates

The application scenarios relating to a manufacturer’s QMS that may allow an abridged assessment to be conducted by the TGA are described below in Table 3.1.

Table 3.1
No. Scenario
1.

An application is made for certification of a manufacturer's QMS under the Schedule 3 Part 1, Part 4 or Part 5 conformity assessment procedures;

and

The manufacturer holds current EC certification issued by a Notified Body under the relevant Annex of an EU Medical Devices Directive (e.g. 93/42/EEC or 90/385/EEC), EU IVD Directive 98/79/EC or ISO13485 certification issued under CMDCAS by a Health Canada recognised registrar;

and

The scope of the EU or HC certification incorporates the same manufacturing sites and device categories relevant to the assessment required for the Schedule 3, Part 1, 4 or 5 conformity assessment certificate;

and

An onsite audit has been undertaken by the assessment body within the previous 12 months;

and

A sufficiently detailed report of the most recent audit (and a sufficiently detailed report of the most recent certification or recertification audit if the most recent audit was surveillance only) has been provided to the TGA.

2.

A currently certified manufacturer plans to implement a substantial change to the quality management system under a Schedule 3 Part 1, Part 4 or Part 5 conformity assessment certificate;

and

An application for assessment of this change is made;

and

The manufacturer holds current and relevant EC certification issued by a Notified Body under an EU Medical Devices Directive (e.g. 93/42/EEC or 90/385/EEC), EU IVD Directive 98/79/EC or ISO13485 certification issued under CMDCAS by a Health Canada recognised registrar;

and

The change has been satisfactorily assessed by the assessment body;

and

A sufficiently detailed report of this assessment has been provided to the TGA.

3.

A currently certified manufacturer plans to implement a substantial change to the quality management system under a Schedule 3 Part 1, Part 4 or Part 5 conformity assessment certificate;

and

An application for assessment of this change is made;

and

The change requires minimal assessment by the TGA (e.g. change to name of manufacturer only).

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, and/or
  • a desk assessment of the QMS documentation (instead of an on-site inspection).

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 and evidence from the manufacturer.

Please note:

  • Approvals by an assessment body not significantly aligned with the Australian regulatory requirements cannot be used as the basis for an abridged assessment. (For example, approvals by the US FDA under the 510(k) process, or QMS certification to ISO9001, are not considered appropriate to allow an abridged assessment).
  • Fees for assessing changes, as specified in Items 1.10 and 1.10A of Schedule 5, already reflect a reduction from full initial fees. When an application is submitted for assessment consequent on change, it may or may not be possible to further reduce these change fees.

3.2.2 Product certificates

The application 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 in Table 3.2.

Table 3.2
No. Scenario
1.

An application is made for conformity assessment certification of a new Class III, AIMD, or Class 4 IVD medical device;

and

The manufacturer holds current and relevant EC certification issued by a Notified Body under an EU Medical Devices Directive (e.g. 93/42/EEC or 90/385/EEC) or EU IVD Directive 98/79/EC or holds a Canadian product licence issued by Health Canada, for the same device;

and

The assessment undertaken for the EC or HC certification incorporated the same elements of an assessment that are required for a TGA conformity assessment certificate under Schedule 3 Part 1 clause 1.6 (Design Exam) or Part 2 (Type Exam)

and

A sufficiently detailed report of this assessment has been provided to the TGA.

2.

The manufacturer plans to implement a substantial change to the design of a device currently certified under Schedule 3 Part 1 clause 1.6 or Part 2;

and

An application for assessment of this change is made;

and

The manufacturer holds current and relevant EC certification issued by a Notified Body under an EU Medical Devices Directive (e.g. 93/42/EEC, 90/385/EEC), EU IVD Directive 98/79/EC or a Canadian product licence issued by Health Canada, for the same device;

and

An assessment of the change has been undertaken for the EC or HC certification

and

A sufficiently detailed report of this assessment has been provided to the TGA.

3.

An application is made for a Schedule 3 Part 2 (Type Exam) certificate for a new device and the manufacturer 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;

and

A sufficiently detailed report of this assessment has been provided to the TGA.

4.

An application is made for Schedule 3, clause 1.6 (Design Exam) certificates for a range of new kinds of either Class III or AIMD or Class 4 IVD medical devices;

and

One application is subject to full design examination;

and

The other applications are similar enough for a concurrent assessment to be conducted.

5.

An application is made for a Schedule 3, clause 1.6 (Design Exam) certificate for a new device;

and

The kind of medical device in the application is similar enough to a device previously subject to full design examination by the TGA.

6.

The manufacturer plans to implement a substantial change to the design of a device currently certified under Schedule 3 Part 1 clause 1.6 or Part 2;

and

An application for assessment of this change is made;

and

The change to the design requires minimal 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, which may include:

  • 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.

Please note:

  • In relation to Design Exam (clause 1.6) or Type Exam (Part 2) certificates, an assessment fee will apply for each 'kind of medical device'. This means that a separate assessment fee will apply to each Unique Product Identifier (UPI) covered by the certificate or application.
  • Type Exam certification under the EU Medical Devices Directives cannot be used to abridge an assessment for Schedule 3, clause 1.6 (Design Exam) conformity assessment certification.
  • Design Exam certification under the EU Medical Devices Directives cannot be used to abridge an assessment for Schedule 3, Part 2 (Type Exam) conformity assessment certification.

3.3 Possible level of reduced assessment fees

The tables below indicate some examples of assessment fee levels that may be considered for different conformity assessment certificate applications, in cases where an abridged assessment is considered appropriate. The TGA delegate may decide that a different percentage of the scheduled fee is more appropriate for a particular application, depending on the level of effort required to conduct the assessment.

3.3.1 Quality system certificates

Table 3.3 Examples of assessment fee levels for Schedule 3, Part 1, Part 4 or Part 5 certificates. Note: these are examples only; each application requires individual consideration due to varying QMS complexity.
Level of Assessment Possible Fee for Schedule 3, Part 1, Part 4 or Part 5 certificates
Issue of a new QMS certificate requiring on-site inspection of manufacturer's facilities including review of QMS documentation and technical files. Full scheduled fee under Item 1.9 or 1.9A applies
Issue of a new QMS certificate where desk assessment of manufacturer's QMS documentation including inspection reports from a Notified Body is possible. 65% of the scheduled fee under Item 1.9 or 1.9A
Assessment of change relevant to a current QMS certificate involving assessment of Notified Body reports and QMS documentation. 65% of the scheduled fee under Item 1.10 or 1.10A
Assessment of a minor change relevant to a current QMS certificate. 30% of the scheduled fee under Item 1.10 or 1.10A
Issue of a new certificate for recertification of a manufacturer's QMS with an expiring TGA certificate where there are no significant changes in the manufacturer's QMS or technical files. 15% of the scheduled fee under Item 1.9 or 1.9A

3.3.2 Product certificates

Product assessments for Schedule 3 Part 1 clause 1.6 (Design Examination) or Schedule 3 Part 2 (Type Examination) vary widely between different kinds of medical devices depending on the component assessments required. For example, a non-IVD medical device may require some or all of the following component assessments:

  • Clinical
  • Engineering
  • Biocompatibility
  • Microbiology (sterility)
  • Biological Science
  • Toxicology
  • More rarely, other components like Pharmaceutical Chemistry

IVD medical devices generally require assessment of multiple components such as analytical and clinical performance, product and specimen stability, risk analysis and management, undertaken in a single IVD assessment.

The TGA assessment plan will consider the number of components requiring assessment and the degree to which those components can be abridged to arrive at an estimate of the total assessment effort required. This will determine whether a reduced fee is possible; or whether supplementary fees may be required.

Table 3.4 Examples of assessment fee levels for Schedule 3, clause 1.6 (Design Exam) or Part 2 (Type Exam) certificates - Note: these are examples only, each application requires individual consideration due to varying device complexity.
Example Levels of Assessment Possible Fee Level for Schedule 3 Part 1 Clause 1.6 or Schedule 3 Part 2 certificates
Design examination certificate for a new kind of device requiring multiple component assessments. Notified Body technical report supplied but contains summaries only. Full scheduled fee under Item 1.9 or 1.9A applies
Assessment of a design change to a currently TGA certified device. All component assessments are not required, Notified Body report supplied and provides sufficient detail to allow abridgement. 65% of the scheduled fee under Item 1.10 or 1.10A
New design examination certificate for a kind of device based on a minor design change to an existing TGA certified device. Abridged assessment possible based on prior TGA assessment. 30% of the scheduled fee under Item 1.9 or 1.9A
New design examination certificate for recertification of a device with an expiring TGA certificate. Abridged assessment possible based on post-market data. 15% of the scheduled fee under Item 1.9 or 1.9A
New design examination of a kind of device which is a system comprising two Class III devices. Multiple component assessments required for each component device. Full scheduled fee under Item 1.9 applies, plus a fee for supplementary assessment under Item 1.12
Design examination certificate for a new kind of IVD medical device. Detailed Notified Body technical report supplied and provides sufficient detail to allow assessment to be abridged.

30% of the scheduled fee under Item 1.9A

Note: fee reduction does not apply to immunohaematology reagent IVDs for which a reduced fee is specified in Schedule 5

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