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, please:

• 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 the TGA at any time (please 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 a medical device, or IVD medical device, application

Open the TBS home page:

• Select 'Login to Business Services'
• Type in your user name 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 that 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.

Note:

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.

Note:

If your GMDN code does not appear in the TGA code tables please email the details to devices@tga.gov.au(link sends e-mail).

• For Class III medical devices, AIMD medical devices 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)

Note on related applications

If you are submitting related applications that should be reviewed and approved together, such as a new variant of an active medical device (i.e. new class III application), and an amendment to an existing component to include the new variant (i.e. variation to an ARTG entry), please ensure this is noted in the application. To assist in the review of the applications, you should attach a cover letter that outlines the related product(s) and the details of the related application(s).

• 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' (this will check that all mandatory fields have been completed)

Note:

Selecting 'Validate' will only ensure that all mandatory fields have been completed. Successful validation does not mean that 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 that 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.

Note:

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

How to pay 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.

Note

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.

What happens next?

Once your application is submitted and the application fee has been paid, the information provided in and with the application will be assessed.

You may be contacted by the TGA and asked to provide product information or your Declaration of Conformity to support your application.