Understanding application audit rules for medical devices including in-vitro diagnostics (IVDs)

We may select any device application for audit

We must select some applications for audit by law and charge assessment fees – these are known as mandatory application audits. The details are in Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002.

Applications that we must select for mandatory audit

We must select the following kinds of device applications for a mandatory audit with assessment fees:

• Class III medical devices supported by EU Medical Device Directive (MDD) certification or
• Class III medical devices supported by Medical Device Single Audit Program (MDSAP) certification with US Food and Drug Administration (FDA) 510(k) clearance or
• any of the following In Vitro Diagnostic (IVD) medical devices supported by:
• EU IVD Directive (IVDD) certification, including self-certification or 
• MDSAP certification, including those with US FDA 510(k) clearance: 
  1. Class 3 IVD and Class 4 IVD medical devices
     1. IVD medical devices intended for self-testing or point-of-care testing
• Class 4 in-house IVD medical devices.

Non-mandatory audits

We may select any other device application for audit without assessment fees – these are known as non-mandatory audits.

Any application for a medical device, including an IVD medical device, may be selected for audit at the discretion of the delegate, to determine or establish if:

• the product is a medical device, including 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, to ensure that this information can be obtained 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.
• the information included in, or with, the application is complete and correct.

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

The notification letter will outline the;

• information that you are required to provide
• timeframe within which you must provide the required information
• audit assessment fee you are required to pay (where applicable).

Time frames for providing documentation

You generally have 10-20 working days to provide information that demonstrates compliance with the essential principles and application of conformity assessment procedures appropriate to the kind of medical device (matters certified under section 41FD of the Act).

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

If you do not provide the requested information and documentation within 10 working days of the date specified in the letter or if you fail to pay the fee associated with the audit assessment (where applicable) your application will lapse.

Presentation of requested documentation

Provide requested information as a complete stand-alone submission.

Provide all requested information in English. Where material is not originally in English, submit a full translation. The accuracy of the translation is the responsibility of the sponsor.

Any text, pictures and drawings must be legible, and pictures and drawings must be clearly labelled.

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, provide the information electronically in the form of a CD or DVD containing all of the relevant material. Send your submission to:
 

List of Supporting Documentation for Medical Device Application Audit

Examples of the documentation you may be required to provide, if your medical device application is selected for audit, are provided in the table below. 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

For medical device (excluding IVD) applications there are two levels of audit assessment:

• Level 1
• Level 2

TGA will determine what level of audit assessment is appropriate for your application. The documents we request you to provide will depend on the level of audit assessment.

For IVD medical device applications there is only one type of audit assessment, sometimes referred to as a technical file review.

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

There is an audit assessment fee for an application that must be selected for audit under 5.3 of the Regulations.

You will receive an invoice if you are required to pay an audit assessment fee.

For medical device (excluding IVD) applications, the audit fee is dependent on the level of audit assessment:

• Level 1
• Level 2

The TGA will determine what level of audit assessment is appropriate for your medical device application and the fee you are required to pay, based on the audit assessment level.

For IVD medical device applications, the audit assessment fee is different depending on the classification of the device.

Current audit assessment fees

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

• 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

Refer to the payment options webpage for ways to pay your application audit assessment fee.

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

Reduction of assessment fees

If audit assessment can be abridged, there are certain circumstances where audit assessment fees can be reduced. For further information see Reduction of assessment fees for medical devices under the heading 'Application Audits'.

Related information and guidance

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

The time taken to conduct the application audit assessment 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.

There are no legislative timeframes for application audits.

Withdrawal of your application

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

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. Refer to refunds for further information.

What happens next?

If your application is withdrawn:

• 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 TGA within the timeframes specified in the notification letter provided to you or fail to pay the associated audit assessment fee, the audit will not continue and your application will lapse.

Examples 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 letter
• comply with a requirement to deliver a reasonable number of samples of the kind of medical device to which the application relates
• 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 letter
• provide information in connection with the application, including information for the purpose of section 41JA of the Act, that is false or misleading in a material particular
• pay an audit assessment fee for the application within 28 days after the day that you were notified of the amount of the fee.

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. Refer to refunds for further information.

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.

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

Outcome of the application audit

Provided your application has not been withdrawn or lapsed, your audit assessment 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 assessment, your medical device, including IVD medical device, will be included in the ARTG.

What happens next?

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
• you can print your ARTG certificate of inclusion 
• you have ongoing responsibilities as a sponsor of a medical device, including IVD medical device, included in the ARTG.

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 assessment, your medical device, including 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. Refer to the TGA Guidance for requesting a reconsideration of an initial decision
• any fees paid will not be refunded. Refer to refunds for information.
• 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.