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Auditing of medical device, including IVD medical device, applications

11 October 2019

This guidance is intended for sponsors who have submitted an application for inclusion of a kind of medical device, or an IVD medical device, in the Australian Register of Therapeutic Goods (ARTG) that has been selected for auditing.

Application audits are conducted for the purposes of verifying that devices submitted for inclusion in the ARTG meet the relevant legislative requirements. There are two circumstances under which an application is audited:

  • The application must be selected for auditing under the legislation
  • The application is selected for auditing at the discretion of the delegate

Applications that must be selected for audit

Note

A certificate issued by the TGA under Part 4 of Schedule 3 of the Regulations for the sterilisation of a system or procedure pack (where the the special conformity assessment procedure under regulation 3.10 and clause 7.5 of Schedule 3 of the Regulations has been applied to the kind of medical device) is not a Conformity Assessment Certificate issued in relation to a kind of medical device. This certificate is issued in relation to the sterilisation of the system or procedure pack, not the system or procedure pack itself.

Therefore, if a system or procedure pack is of a kind of medical device listed above, it must be selected for audit.

Applications selected at the discretion of the delegate

Any application for a device, including an IVD medical device, may be selected for audit at the discretion of the delegate.

A delegate may choose to select a device application for audit in order to determine or establish whether:

  • The product is a medical device or an IVD medical device
  • The clinical benefit of the device outweighs any risk associated with its use
  • The device is being included for the purpose intended by the manufacturer
  • Your application contains information that is false or misleading
  • The device is correctly classified
  • You have:
    • sufficient information available to substantiate compliance with the Essential Principles; or
    • procedures in place, including a written agreement with the manufacturer, to ensure that this information can be obtained within the period required under the Regulations.
    • sufficient information available to substantiate the application of those conformity assessment procedures; or
    • procedures in place, including a written agreement with the manufacturer of the device, to ensure that this information can be obtained from the manufacturer within the period required under the Regulations.
  • The device does not contain substances that are prohibited imports for the purposes of the Customs Act 1901
  • Information included in, or with, the application is complete and correct

Steps in the audit process

The following web pages:

  • Identify the steps in the audit process
  • Outline the fees associated with the audit process
  • Describe the timeframes for completing the auditing process
  • Explain the withdrawal or lapsing of your application during the auditing process
  • Explain the auditing process and its outcome

This is an outline of the information contained in the following web pages and the associated guidance documents

  1. The application audit process
    1. Time frames for providing documentation
    2. Presentation of requested documentation
  2. Audit Assessment Fees
    1. Current assessment fees
    2. How to pay assessment fees
    3. Reduction of assessment fees
  3. Target timeframes for conducting audits
  4. Withdrawing and Lapsing your Application
    1. Withdrawal of the application by you
    2. Lapsing application
  5. Auditing your Application and Outcome
    1. Outcome of the application audit
    2. Decision to include your device in the ARTG
    3. Decision not to include your device in the ARTG

Step 1 - The application audit process

If your application is selected for audit, you will be notified within 20 days of paying the application fee associated with your application via a notification letter issued under section 41FH of the Therapeutic Goods Act 1989.

The notification will outline;

  • A list of the information that you are required to provide.
  • The timeframe within which the required information is to be provided.
  • The audit assessment fee you are required to pay (where applicable).

Note

You will need to pay the fee associated with the audit (where applicable) and supply the information requested within the time frames given in the notification otherwise your application will lapse. If you allow your application to lapse, your application fee will not be refunded.

Time frames for providing documentation

For the purpose of obtaining information that demonstrates that the matters certified under section 41FD were correct in relation to the compliance with the essential principles and application of conformity assessment procedures appropriate to the kind of medical device, the period for obtaining information is 20 working days.

In relation to all other matters, the period for obtaining information is no less than 10 working days from the day on which the notice is given.

The date for providing the requested information will be specified in the notification.

If you do not provide the required information and documentation within the timeframes given, or if you fail to pay the fee associated with the audit process (where applicable) your application will lapse.

Note

Once you have supplied the information requested and it has been assessed, you may be required to provide further information under section 41JA of the Act.

Presentation of requested documentation

  • Requested information must be provided as a complete stand-alone submission.
  • All requested information must be provided in English. Where material is not originally in English a full translation must be submitted, the accuracy of which is the responsibility of the sponsor.
  • Any text, pictures and drawings must be legible, and pictures and drawings must be clearly labelled.
  • Advertisements for medical devices that are directed to consumers are required to comply with Chapter 5 of the Act, Part 2 of the Therapeutic Goods Regulations 1990 and the Therapeutic Goods Advertising Code.
  • If your submission is less than 15 pages, you may clearly state the application ID and the applicant name in the subject line and email your submission to: devices@tga.gov.au.
  • If your submission is longer than 15 pages, it should be sent to:

Devices Application and Verification Section
Medical Devices Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

The information should be provided electronically in the form of a CD or DVD containing all of the relevant material.

List of supporting documentation for medical device application audit

The list below provides an example of the information you may be required to provide if your medical device application is selected for audit. This list is not definitive and, depending on the nature of your application, you may be required to provide documentation not contained within this list.

Levels of application audit

There are two levels of assessment audits:

  • Level 1
  • Level 2

TGA will determine what level of assessment audit is appropriate for your application and the documents you are asked to supply will depend on that level of assessment.

Example of documentation that may be required for each level of audit
Level Example of documentation that may be required for each level of audit
Level 1 Manufacturers Declaration of Conformity(DOC)
For a system or procedure pack where special conformity assessment procedure provided under clause 7.5 of Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) has been applied to the kind of medical device you will need to provide evidence of compliance of the kind of medical device with the requirements under regulation 3.10 of the Regulations and clause 7.5 of Schedule 3 of the Regulations.

Information to be provided with the 'kind of medical device' and used to promote the kind of medical device in Australia including copies of:

  • labelling
  • pictorial images of the device
  • packaging - inner and outer packaging for the device
  • instructions for use
  • product manual
  • other brochures related to the device
  • advertising material for the medical device including brochures, extracts from web pages, and advertisements
  • medical device patient cards and leaflets
Level 2 Includes all the documentation listed above for a level 1 audit
Clinical evidence.
Risk management report.
Efficacy and performance data for medical devices that are intended to be used for disinfecting other medical devices.

Step 2 - Audit assessment fees

There is no assessment fee if your application has been selected for audit at the discretion of the delegate.

There is an assessment fee for an application that must be selected for audit under the Regulation 5.3. For a medical device, the fee is dependent on the level of audit.

There are two levels of assessment audits for medical devices:

  • Level 1
  • Level 2

The TGA will determine what level of assessment audit is appropriate for your medical device application and the documents you are asked to provide, as well as the fee you are required to pay, which will depend on that level of assessment.

For IVD medical device applications there is only one type of application audit and related assessment fee.

If you are required to pay an audit assessment fee, you will receive an invoice.

Current assessment fees

To access the current assessment fees go to the Schedule of fees and charges website:

  • click on 'Medical devices' or 'IVD medical devices'
  • the assessment fees are listed under 'Application audit assessment fees'

How to pay the required application audit assessment fee

There are a range of payment options for payment of your application audit assessment fee. For further information refer to the payment options webpage.

If you do not pay the audit assessment fee your application will lapse under s41FK of the Act.

Reduction of assessment fees

There are certain circumstances where audit assessment fees can be reduced if audit assessment can be abridged. For further information refer to Reduction of assessment fees for medical devices  under the heading 'Application Audits'.

Therapeutic Goods Regulations 1990 (Schedule 9 - Table of fees).

Step 3 - Time frames for conducting audits

The time taken to conduct the audit for your device is dependent on a number of factors including:

  • the time you take to pay the audit assessment fees (if applicable);
  • the time you take to provide requested information; and
  • the quality of the information you provide to the TGA.

Note

There are no legislative timeframes for application audits.

Step 4 - Withdrawing or lapsing your application

Withdrawal of your application

You may withdraw your application at any time prior to a decision being made whether or not to include the medical device, or IVD medical device, in the ARTG. If you wish to withdraw your application, you can do so through TBS.

Note

Any fees you have paid will not be refunded if you withdraw your application. Once you have paid a fee there are very limited circumstances under which you will be able to obtain a refund. For further information refer to the refunds web page.

What happens next?

You will receive an email confirming that your application has been withdrawn.

You cannot supply the kind of medical device as it has not been included in the ARTG.

You can resubmit a new application and recommence the process at any time.

Lapsing your application

If you fail to comply with any request made by the TGA within the timeframes specified in the notice provided to you, the audit will not continue and your application will lapse.

This may include failure:

  • to comply with a notice under section 41FH of the Act within 10 working days after the end of the period specified in the notice
  • to comply with a requirement to deliver a reasonable number of samples of the kind of medical device to which the application relates
  • to comply with a notice under section 41JA of the Act to give information relating to devices of that kind within a further 10 working days from the day specified in the notice
  • to provide information in connection with the application, including information for the purpose of section 41JA, that is false or misleading in a material particular
  • to pay an audit assessment fee for the application within 28 days after the day that you were notified of the amount of the fee

Note

Any fees you have paid will not be refunded if you allow your application to lapse. Once you have paid a fee there are very limited circumstances under which you will be able to obtain a refund. For further information refer to the refunds web page.

Lapsing of the application is not a decision of the Secretary, and is not subject to a review under section 60 of the Act.

What happens next

If your application is lapsed:

  • You will receive written notification outlining that your application has lapsed and the reasons why your application has lapsed.
  • You cannot supply the kind of medical device as it has not been included in the ARTG.
  • You can resubmit a new application and recommence the process at any time.

Step 5 - Auditing your application and outcome

Once your application audit has been completed and a decision is made you will receive notification regarding the outcome of your application audit.

Outcome of the application audit

Provided your application has not been withdrawn or lapsed, your audit will conclude with one of the following outcomes:

  • decision to include your kind of device in the ARTG.
  • decision not to include your kind of device in the ARTG
Decision to include your kind of device in the ARTG

If the delegate is satisfied as to all aspects considered in the audit, your medical device, or IVD medical device, will be included in the ARTG.

If a decision is made to include the kind of medical device in the ARTG, you will receive email notification outlining the decision to include your medical device in the ARTG.

Go to Step 8 and Step 9 of the Medical device ARTG inclusion process

Decision not to include your kind of device in the ARTG

If the delegate is not satisfied as to all aspect considered in the audit, your medical device, or IVD medical device, will not be included in the ARTG.

What happens next

If a decision is made not to include your kind of medical device in the ARTG:

  • You will receive written notification outlining:
    • the decision not to include the device in the ARTG
    • the reasons for not including the device in the ARTG
    • information about the appeal process under section 60 of the Act
  • You may request a review of this decision under section 60 of the Act. For further information on the appeal process under section 60 of the Act refer to the TGA internal review guideline.
  • Any fees paid will not be refunded. For further information refer to the refunds web page.
  • You cannot supply the kind of medical device as it has not been included in the ARTG.
  • You can recommence the process to include the kind of medical device in the ARTG at any time.

Version history
Version Description of change Author Effective date
V1.0 Original publication Medical Devices Branch October 2019