Submitting an application in TBS (for all classes except Class I non-sterile, non-measuring medical device, Class 1 IVD medical device and Class I medical device/Class 1 IVD medical device Export Only)

Before you commence your application for inclusion:

• Ensure your Manufacturer's Evidence has been submitted and accepted.
• Ensure you have any required documentation as outlined in the final column 'Documentation to be provided with the application (Evidence of product assessment)' of Table 2 in the Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs) as you will need to attach these document/s to your application (if applicable) in order to pass preliminary assessment.
• In addition to the above, you should ensure that you have the following available as it may be requested by us at any time (note, this information should not be attached to your device application):
  • information 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.
  • If a device is a borderline medicine/medical device then information such as mechanism of action and rationale to justify whether your product meets the definition of a medical device must be kept available.
  • Evidence to demonstrate compliance with the Essential Principles. For high-risk devices this may include the clinical evidence report and/or risk management report.

How to submit your application

Open the TBS home page- external site:

• Select 'Login to Business Services'
• Type in your username and password
• Click on 'Portal'
• From the 'Create Applications & Submissions' menu, select 'Device/OTG Application' under the 'Medical Device' heading. This will take you to the Device Application page:
• In the 'Application for:' box, select 'Medical Device - Included' for a medical device or 'Medical Device - IVD' for an IVD medical device
• Complete all questions on all pages
• Select the relevant class of the medical device or IVD medical device. Note the fee for your application appears once you select the classification.
• Please answer the remaining questions correctly using the information provided to you from the manufacturer of the product.

There are some questions that are appropriate for more than one class of device - the onus is on the sponsor to provide correct information and choose the correct classification for their product.

• Once you have completed the first page, you will need to select 'Next' to progress.
• Select your manufacturer and relevant Manufacturer Evidence then select the GMDN code.

It is the manufacturer's responsibility to inform you of the appropriate GMDN code according to the GMDN Agency website. If the GMDN code does not appear in the TGA code tables, please refer to the manufacturer for the most up-to-date GMDN code.

View our guidance on GMDN codes, here:

• Introduction to Global Medical Device Nomenclature (GMDN) codes- external site- external site
• The use of GMDN codes for IVD medical devices in Australia

• For Class III medical devices, AIMD medical devices, Companion Diagnostics and Class 4 IVD medical devices (except Class 4 IVD medical devices that are immunohaematology reagents) complete the Unique Product Identifier (UPI), functional description, total number of devices covered and where applicable, variant type and variant range.
• Once you have completed the second page and you select 'Next' you will be taken to the 'Applicant's Certification' page. A summary of the information you have entered will be provided.
• Attach any documentation required as outlined in the final column 'Documentation to be provided with the application (Evidence of product assessment)' of Table 2 in the Use of market authorisation evidence from comparable overseas regulators/assessment bodies for medical devices (including IVDs)
• Review the Declaration (in electronically submitting the application you are declaring that in relation to the device the information given in the application and the statements in the declaration are current and correct).
• Select 'Validate'.

Selecting 'Validate' will only ensure that all mandatory fields have been completed. Successful validation does not mean the information entered has been confirmed as correct as some responses may be suitable for more than one classification. It is the sponsor's responsibility to ensure they have selected the correct classification for their medical device and that the information provided is complete and correct.

• If validation is successful 'Validation successful' will appear at the top of the application.
• If you have missed an entry, the system will not validate and will provide you with a message relating to any missing information (e.g. you have not entered the intended purpose). You will need to complete the missing information before you can proceed.
• Once you have successfully validated your application, you will be able to click 'Submit'.
• Select 'OK'.
• The system will provide confirmation that your application has been submitted.
• To view your lodged application, click on 'view lodged submissions'.
• An invoice will be sent to you or an individual in your organisation who is responsible for payment of fees.
• Pay the relevant application fee.

You will be required to pay a separate assessment fee if your application is subject to a mandatory application audit.

Paying your application fee

We provide a range of payment options for payment of your application fee. For further information refer to the Payment options webpage.

Your application will not be processed until you have paid the application fees, and it has been applied to your application. It is important you indicate which application the application fee is for, so the link can be easily made and applied.

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 webpage.

Next steps

Once your application is submitted, the application fee has been paid and linked the application enters the preliminary assessment queue. Once in the queue it may take up to 20 business days before the application is reviewed and either included in the ARTG, refused or selected for audit. 

We may contact you to request further product information or your Declaration of Conformity- external site to support your application.

We will advise you, via TBS, whether your device has been included in the ARTG.