Understanding selection criteria for medical device application audits

Application audits are intended to verify that devices comply with Australian regulatory requirements before they are included in the ARTG. 

Audits can be undertaken for any type of medical device, including in vitro diagnostic (IVD) medical devices. 

While we may select any application for any reason, we generally use four main risk-based criteria to guide which applications to select. 

Using a risk-based approach allows us to focus regulatory efforts proportional to risk, reducing regulatory burden and costs while providing Australians with timely access to safe devices.

The main criteria outlined below may change over time to account for emerging safety or performance risks. 

We may identify new risks including through post market signals or remove a risk from the selection criteria.

This guidance will be reviewed and updated regularly. You are encouraged to subscribe to our website to ensure you hold the current version.  

To meet the minimum requirements for a medical device application, you must attach the documents specified on our Using assessments from comparable overseas regulators for medical devices guidance.

To support efficient assessment and reduce the likelihood of audit delays, we encourage you to also submit key supporting documents with your application. 

The following documents help us verify compliance with requirements and may reduce the need for additional information requests:

• Cover letter
  The cover letter should provide a concise overview of the application and clearly outline any supporting documents included. It should also identify any related risks or dependencies associated with the application. For example, if the application is for a reagent that requires an instrument or analyser, it is helpful to reference the application number or ARTG details of the related instrument and any associated controls. Similarly, if the application involves software that interfaces with a medical device, or a device that relies on specific software or accessories, the cover letter should include reference to these and explain the compatibility. Additionally, the cover letter should refer to any relevant selection criteria outlined in this guidance and highlight any other information that supports the application.
• Instructions for Use (IFU) or labels 
  IFU must be provided for all class III medical devices.
• We recommend that you provide the IFU for all self-tests, point of care tests, class 3 and 4 IVD medical device applications. If the application is supported by comparable overseas regulator approval, also provide evidence of their assessment such as Performance Evaluation Assessment Report (PEAR), if available. 

We may contact you to request further documents or to clarify information. 

Your timely response will help us ensure your application progresses efficiently and to meet processing timeframes. 

Where possible, include complete and clearly labelled documents to help our assessment.

Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2002 requires the TGA to always select some types of applications for audit. 

This process is referred to as a “mandatory audit”. If your application must have a mandatory audit, you will be required to pay a fee for this assessment.

In 2024, Regulation 5.3 was amended to limit mandatory application audits to only some types of higher risk applications, as outlined below. 

The following applications must be selected for mandatory audit:

• Class III medical device applications supported by European Union (EU) Medical Devices Directive (MDD) certificates
• Class III medical device applications supported by US 510(k) pre-market notification approval
• System Or Procedure Pack (SOPP) applications supported by a Declaration of Conformity made under Schedule 3 Clause 7.5 with one or more components that are:
  • Class III medical devices supported by EU MDD certificates or US 510(k) approval
  • A class 4 IVD, class 3 IVD, point-of-care IVD, self-test IVD, or class 4 in-house IVD
• Class 4 IVD, class 3 IVD, point-of-care IVD and self-test IVD applications supported by:
  • EU IVD Directive certificates
  • ISO 13485 certificates and EU Declaration of Conformity
  • Medical Device Single Audit Program (MDSAP) certificates and without comparable overseas regulator approval for the device.

Information we will request

When an application has been selected for audit, we will explain the focus of the audit and request additional information required. 

For many applications, we will not need to request additional information as the information we need for the audit (e.g. clinical evidence) will already be included with your application. 

For IVD medical device applications, mandatory audits will typically be a full assessment of a complete technical file which includes but not limited to information such as clinical and analytical performance studies, stability studies and device specific studies such as usability studies for self-test devices. 

Additional guidance on preparing a technical file based on the device classification can be found here:

• Preparing a technical file review for IVD medical devices
• Understanding the medical device application audit process

Any application for a medical device, including an IVD medical device, may be selected for “non-mandatory audit”. 

Selection is based on our published audit selection criteria and outlined in this guidance. 

There is currently no fee if your application is selected for non-mandatory audit.

We base our risk assessment and audit selection decision on information in your application, and information held in TGA records and systems. 

We select applications for audit after we complete preliminary assessment. 

Our further scrutiny of your application will depend on the classification and risks associated with the device. 

There are four criteria we use to select applications for non-mandatory audit:

• Criterion 1: Aspects related to the application and the device
• Criterion 2: Kinds of devices subject to regulatory reforms
• Criterion 3: Post market signals
• Criterion 4: Factors related to the sponsor or manufacturer

If multiple criteria apply to an application, the audit may involve assessment of a broader range of issues by more than one specialist assessment team.

The TGA will exercise discretion for audit selection. 

For example, we may not select an application for audit, if it meets a criterion, and:

• the sponsor has acknowledged that they meet an audit selection criterion, and has:
  • addressed this in their applications, and
  • included relevant evidence to address the risk
• if after internal review we are satisfied that the identified criterion does not represent a potential regulatory non-compliance.

1.1 Clarification of information in the application

During preliminary assessment we will review your application to ensure it is complete and correct. 

We may select your application for a non-mandatory audit if we have any ongoing concerns about the device raised during this stage. 

These concerns may relate to a variety of factors. 

For example, they may include, but are not limited to, the following:

• the clinical evidence provided with the application raises concerns about its adequacy to support the intended purpose
• the intended purpose in the application differs from the intended purpose approved by the comparable overseas regulator and we need more information to assess compliance
• the comparable overseas regulator has imposed conditions of market authorisation that may impact the safety or performance of the device in Australia
• we have concerns about the class of the device, including if there are known classification differences in the country of approval and we need to confirm the class in Australia
• we have concerns that the device assessed by the notified body for European IVD Regulation certification (specifically for class 3 IVDs), may not be representative of the devices to be supplied in Australia
• where the IVD sample type, analyte, or target population differs from that approved by the comparable overseas regulator. 

What you can do

If you believe your device is likely to be selected for audit because it meets one of the above criteria, you may attach a cover letter with more information that explains, for example the differences between the comparable overseas regulator approval and your application. 

Information we will request

If your application meets criteria 1.1, we will clearly identify what information we require for review, this may include a range of documents relevant to the reason for audit selection. 

For example, if we have concerns relevant to clinical evidence, we may request documentation that demonstrates how the device complies with the Essential Principles. 

If the concern is that the device has a broader intended use in Australia than what was approved by the comparable overseas regulator, we will only request data supporting the broader indication.

1.2 Regulatory history

The regulatory history of a device is an important aspect we consider when reviewing an application. 

We will check if a previous application was made to the TGA for the same device (or a closely related device) that had unresolved safety or performance concerns. 

We will also consider any history of regulatory action taken by the TGA.

We may also select an application for audit if the manufacturer has a known history of non-compliance or identified breaches of their quality management system by a comparable overseas regulator. 

If safety and performance deficiencies identified under any previous application process remain unresolved, the new application is likely to be selected for non-mandatory audit, even if the application has been submitted by a different sponsor. 

The purpose of the audit will be to ensure identified deficiencies or concerns have been appropriately addressed and closed out.

What you can do

While we cannot provide you with information about whether we have ever received and refused an application for the device from another sponsor, you could consider asking the manufacturer of the device if they are aware of any prior applications.

If the device you are submitting has previously been withdrawn, refused or remains pending for any reason, you may consider requesting a regulatory engagement meeting before you apply to discuss the relevant evidence required as part of a new application.

If you are aware that there has been a previous application and the concerns associated with the device have been addressed, you may consider attaching a cover letter to the application explaining what the manufacturer has done to address or mitigate the risks and deficiencies in the previous application, and if relevant, include any updated clinical evidence reports or instructions for use

Information we will request

If your application meets criteria 1.2, we will clearly identify what information we require for review, this may include a range of documents relevant to the reason for audit selection and the precise nature of any regulatory history concerns. 

1.3 Regulatory pathway

If the device has been approved by a comparable overseas regulator via certain regulatory pathways, we are likely to select the application for audit.

1.3.1 Japanese pathway with no clinical review

We will select applications for Class III medical devices that use Japanese Pharmaceuticals and Medical Devices Agency (PMDA) certification based on the generic or improved application categories, completed without clinical review or trial, for a non-mandatory level 2 audit. 

The PMDA certificate outlines the ‘Application Category’ and specifies whether a clinical review or trial was undertaken. 

These categories may allow manufacturers, under limited circumstances, to leverage only non-clinical evidence to demonstrate the device meets safety and performance requirements. 

The application audit will focus on assessing the clinical evidence against Australian requirements.

Note
This pathway is not applicable for IVD medical devices.

What you can do

If you are applying for a Class III medical device that is supported by PMDA certification that did not involve clinical review, you may consider requesting a regulatory engagement meeting before you apply to discuss the relevant evidence required as part of a new application.

Information we will request

We will request clinical evidence that demonstrates compliance of the device with the Essential Principles. 

If additional risks are identified, we may also request other supporting information

For information regarding specific expectations for clinical evidence requirements, refer to our Clinical evidence guidelines.

1.3.2 Class 4 IVDs with cadaveric claims

Class 4 IVDs with cadaveric claims will be selected for a non-mandatory application audit, unless the device is supported by US FDA Premarket approval. 

The Australian requirements for these devices align with US FDA PMA requirements but not with other comparable overseas regulators. 

The audit will focus on ensuring your device meets all relevant Australian regulatory requirements.

What you can do

If you are applying for a Class 4 IVD with cadaveric claims that is not supported by US FDA Premarket approval, you may consider requesting a regulatory engagement meeting before you apply to discuss the evidence required.

Information we will request

We will request reports of studies undertaken that align with the US FDA requirements for these devices.

1.3.3 Heart valves with claims of equivalence or without US FDA PMA

Transcatheter heart valves that claim equivalence to a predicate device and are supported by approval from a comparable overseas regulator may be selected for audit, with a focus on evaluating the clinical evidence supporting the claimed equivalence.

Similarly, heart valves that are supported by approval from a comparable overseas regulator other than a US FDA original PMA or PMA panel-track supplement, will be subject to a non-mandatory application audit.

The US FDA clinical evidence requirements align with Australian requirements, unlike those of other jurisdictions such as the EU. 

The audit will assess the clinical evidence against Australian requirements.

What you can do

If you are applying for a transcatheter heart valve or any heart valve supported by comparable overseas regulator approval, including cases where the evidence is not from a US FDA original PMA or PMA panel-track supplement, you may request a regulatory engagement meeting before submitting your application to clarify the clinical evidence requirements.

Information we will request

We will review the clinical evidence you provide with the application. If additional risks are identified, we may also request other supporting information.

1.3.4 Singapore abridged IVD pathway

IVD medical device applications that have Singapore Health Sciences Authority (HSA) approval via an abridged pathway such as approvals granted using US FDA 510k or EU IVDD approval will be selected for a non-mandatory level 2 audit.

Note
Class 3 or 4 IVD applications with US FDA 510k or EU IVDD approval must be selected for a mandatory application audit.

What you can do

If you are submitting an IVD medical device application that has Singapore HSA approval via an abridged pathway using US FDA 510k or EU IVDD approval, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application. 

A cover letter with the information on the approval pathway (i.e. whether the HSA approval was through full assessment or abridged assessment) will help achieve an efficient preliminary assessment.

Information we will request

We will undertake a full assessment and request the complete technical file for the device which includes but not limited to information such as clinical and analytical performance studies, stability studies and device specific studies such as usability studies for self-test devices.

1.3.5 Class 1 IVDs for point of care testing

Class 1 IVDs for point of care testing may be selected for a non-mandatory application audit. 

The audit will focus on the evidence that the test performs as intended in the point of care setting.

What you can do

If you are applying for a Class 1 IVD for point of care testing, you should ensure you have access to the manufacturer’s technical file for the product. 

You may consider requesting a regulatory engagement meeting before you apply to discuss the evidence required.

Information we will request

We will request clinical and analytical performance studies to verify the test performs as intended in the point of care setting. 

The TGA has been implementing a number of regulatory reforms, including those outlined in An Action Plan for Medical Devices. 

These reforms aimed to enhance the safety, performance, and quality of medical devices in Australia and to focus on patient safety. 

If your kind of device was subject to the regulatory reforms, and is outlined below, your application will be selected for a non-mandatory application audit.

2.1 IVD companion diagnostics

Each IVD companion diagnostic requires a separate application. 

We may select these applications for non-mandatory audit and assess the technical documentation for each product to ensure the safety and performance of the companion diagnostic and the associated medicines or biologicals. 

The audit will focus on whether there is sufficient evidence that the IVD matches the applicable core characteristics of the clinical trial IVD that supported registration of the relevant indication for use, for the corresponding medicine or biological.

What you can do

Provide evidence of approval (such as the assessment reports) from any comparable overseas regulator. This will help us decide on the scope of the assessment. More information about how we regulate IVD companion diagnostics is on our website at:

• Medical devices reforms: IVD companion diagnostics
• Further information about our requirements including instructions for use, product information for corresponding medicines and biologicals, and clinical evidence is at Guidance on regulatory requirements for IVD companion diagnostics.

Information we will request

We will request the information outlined in the above guidance.

2.2 Classification of medical device software

A range of reforms have recently been implemented to improve the regulation of software-based medical devices, including software as a medical device (SaMD). During preliminary assessment of applications for medical device and IVD software, we will focus on checking the devices are correctly classified and certified under the new Australian SaMD classification rules and the IVD classification rules and principles.

In some complex cases, this may result in a non-mandatory application audit to ensure the device is correctly classified. SaMD classification rules do not apply to IVD medical devices.

What you can do

You can attach a cover letter explaining the classification of the device. The cover letter can explain the device function, intended purpose and justification for the classification rules that apply.

Information we will request

To understand the device and its function, we will ask for an IFU and an explanation on the classification.

2.3 Software and artificial intelligence (AI)

We may select higher risk device applications (Class IIb, III and Class 3 and 4 IVD’s) identified as incorporating AI technologies (such as Machine Learning, Large Language Models (LLMs) etc.) for an application audit. Our assessment will focus on how the AI contributes to the intended purpose of the device.

What you can do

If you are applying for software that uses AI, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application.

Information we will request

Clinical evidence presented that demonstrates compliance of the device with the Essential Principles. 

If review of the clinical evidence identifies additional risks, we may also request other supporting information including risk management documentation, an explanation of the AI and its validation, including information about the data used to train and test the AI.

More information about how we regulate software based medical devices and AI is available on our website at:

• Software-based medical devices
• Is my software regulated?
• Regulation of software based medical devices
• Medical devices reforms: Medical device software regulation
• Classification of active medical devices (including software-based medical devices)
• The European Union Medical Device Regulation – Regulation (EU) 2017/745 (EU MDR)
• The European Union In vitro Diagnostic Medical Device Regulation – Regulation (EU) 2017/746 (EU IVDR)
• Essential Principle 13B guidance

2.4 Patient-matched medical devices (PMMDs)

Recent changes to the regulation of patient-matched medical devices manufactured within a design envelope mean we are likely to select applications for higher risk devices (Class IIb and III) for audit to ensure the device meets Australian regulatory requirements.

What you can do

If you are making an application for patient matched devices, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application.

Information we will request

Clinical evidence that demonstrates compliance of the device with the Essential Principles. 

If additional risks are identified, we may also request other supporting information that will be clearly identified through our correspondence.

More information about patient-matched medical devices is available at:

• Personalised medical devices
• Medical devices reforms: Personalised medical devices.

2.5 Patient implant cards and patient information leaflets

All implantable and active implantable medical devices must have patient information materials available in the form of both Patient Information Leaflets and Patient Implant Cards, unless specifically excluded from these requirements. 

Patient implant cards and patient information leaflets must meet requirements set out in the Essential Principles.

What you can do

We usually review patient implant cards and patient information leaflets during preliminary assessment of the application. 

However, if the patient implant card and patient information leaflet for your device are not provided with your initial application, we will select your application for a level 1 audit.

Information we will request

We will request the patient implant card and patient information leaflet for your device.

Information about patient implant materials is on our website at:

• Medical device patient information leaflets and implant cards.

2.6 Medical devices with a medicinal substance

A medicinal substance incorporated in a medical device must be manufactured according to Good Manufacturing Practice and meet the Australian manufacturing and quality control requirements. 

We do not need to verify these requirements for applications that rely on TGA or European Union certification, as these processes ensure Australian regulatory requirements are met.

However, we may select applications for medical devices incorporating medicinal substances for audit when they rely on comparable overseas regulator approvals other than from the EU. We do this to confirm that the medicinal substance meets Good Manufacturing Practice requirements.

More information about devices with medicinal substances is available on our website - Medicinal substances in medical devices.

What you can do

You can attach a cover letter with information about the device and the medicinal substance, the device intended purpose, formulation, mechanism of action, and how the Australian Good Manufacturing Practice requirements are satisfied.

Information we will request

We will request information about the device and the medicinal substance, the device intended purpose, formulation, mechanism of action, and how the Australian Good Manufacturing Practice requirements are satisfied. If additional risks are identified, we may also request other supporting information.

2.7 Vaping medical devices

Vaping products meet the definition of a medical device and will be selected for a non-mandatory audit to ensure they meet all relevant regulatory requirements.

For medicinal cannabis vaping devices, and for therapeutic vaping devices for smoking cessation and the management of nicotine dependence, we will focus on verifying that the device is correctly classified as class IIb and has appropriate comparable overseas regulator evidence for the device.

More information about the regulation of vaping products is available here:

• Vaping hub
• Possessing and supplying vaping goods in Australia
• Importing vaping devices into Australia | Office of Drug Control (ODC).

What you can do

Familiarise yourself with how Vapes are regulated in Australia and consider the appropriate regulatory pathway for your device.  

You should consider the Standards for therapeutic vaping devices checklist to help you design, develop and assess your device to comply with Australian requirements. 

We developed this checklist for therapeutic vapes for smoking cessation or the management of nicotine dependence. 

Some parts of the checklist may not apply to medicinal cannabis vaping devices.  

If you are making an application for a vaping device, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application.

Information we will request

We will ask for evidence that the manufacturer correctly classified the device against Australian classification rules, and that the comparable overseas regulator evidence is appropriate for a class IIb device.

2.8 Button batteries

The Australian Competition and Consumer Commission (ACCC) has highlighted the risk of button batteries inadequately sealed in battery compartments, leading to death or serious injury if swallowed by children. 

We may select medical devices that use button batteries for non-mandatory audit to ensure they meet the mandatory standards for these batteries. 

More information about our approach is available on our website.

What you can do

We are familiar with many types of devices that often use button batteries. 

If we are unsure, we may contact you to confirm if the device uses button batteries. 

You are encouraged to proactively disclose this information in the cover letter or application materials to support timely and accurate assessment. 

You can also attach a cover letter explaining how your device meets the mandatory safety requirements for devices with button batteries.

Information we will request

The ACCC has published further guidance and information:

• Consumer Goods (Button/Coin Batteries) Safety Standard
• Consumer Goods (Products Containing Button/Coin Batteries) Information Standard
• Button/coin battery safety: a guide for business on the application of mandatory standards, to help suppliers understand the requirements.
• A fact sheet, which summarises the four standards.

2.9 Mercury containing devices

Australia is a signatory to the Minamata Convention that requires parties to take steps to prohibit or restrict the import, export, and manufacture of therapeutic goods containing mercury. The Convention also includes phase out dates for mercury-added products. 

We may select any device that contains mercury for a non-mandatory audit.

What you can do

If you are making an application for mercury containing devices, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application.

Information we will request

We will request information that justifies the use of mercury in the device, considering the international agreement to phase out its use. This should include evidence demonstrating that the benefits of its use outweigh the associated risks.

2.10 Substances introduced into the body or absorbed by the skin

For a medical device that is a substance, or a combination of substances, that are introduced into the body or absorbed by the skin, we may select the application for audit to confirm that the product is a medical device and not a medicine.

Guidance can be found here, Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin.

What you can do

You can attach a cover letter with information explaining why the product is a medical device and not a medicine, including the device intended purpose, formulation, and mechanism of action.

Information we will request

We will request an explanation for why the product is a medical device and not a medicine, including the device intended purpose, formulation, and mechanism of action. If additional risks are identified, we may also request other supporting information.

We conduct post-market reviews of medical devices supplied in Australia to check that devices continue to be safe and fit for their intended purpose and perform as expected throughout their life. 

Post market reviews are an important feature of how we regulate medical devices in Australia and confirm that sponsors are meeting their ongoing legal obligations once their device has been included in the ARTG. 

More information about post market reviews including details about significant reviews currently underway, is on our website: Medical device post-market reviews.

To support the effectiveness of the post market review program, and to ensure the safety and performance of devices, we will:

• select applications for devices that are the subject of significant recent or ongoing post market reviews for an application audit
• select applications for audit if other post market signals identify a substantial risk for patients arising from certain technologies or clinical uses of a device, or an increased trend in a known harm or identification of a new or emerging harm.

The following devices have previously been the subject of post market review and will be selected for non-mandatory audit:

• Breast implants
• Foetal dopplers
• Airway clearance devices
• Hyperbaric chambers
• Injectables – cosmetic and dermal fillers
• Joint replacement – Patella metal-backed
• Reprocessed or refurbished devices
• Spinal cord stimulators
• Surgical mesh
• Vaginal rejuvenation medical devices
• Ventilators – Universal, BiPAP, CPAP

What you can do

If you plan to apply for devices identified in the above list, you may request a regulatory engagement meeting before you apply to discuss the evidence required as part of a new application.

Information we will request

We will request technical information that addresses the risks and issues we reviewed in the post market review or in the relevant post market signals. In some cases, this may be engineering or material safety data, whereas in other cases, we may ask for the clinical evidence for the device. 

We will clearly identify any additional information that we need in our audit selection correspondence.

If we identify that a certain sponsor or manufacturer has a broad and consistent history of submitting non-compliant medical device applications to the TGA, or of supplying unsafe or non-compliant medical devices, we are more likely to select applications associated with that manufacturer or sponsor for a non-mandatory application audit.

Information we will request

We will review your application and any consistent history of non-compliance to assess the risks. 

We will clearly identify any additional information that we need in our audit selection correspondence.