Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)

How to submit an application form for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)

Open the TBS home page:

• Click on 'Login to Business Services'
• Type in your user name and password
• From the 'Applications' 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 (Export Only)' for a medical device or 'Medical Device - IVD (Export Only)' for an IVD medical device
• 'Sponsor's own reference' is a free text box. Please use any words that will help you identify the specific product for your own purposes.
• Note that the fee for your application appears below the classification:
• Please answer the remaining questions using the information provided to you from the manufacturer of the product.
• Once you have completed the first page, you will need to select 'Next' to progress.
• Select your manufacturer and provide the export names of your device(s).
• 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.

Note

For Class I medical device export only and Class 1 IVD medical device export only applications you are required to attach the manufacturer's Declaration of Conformity to the application.

• Review the Applicant's Certification before selecting Yes or No (in electronically submitting the application you are certifying that the information given in the application and the statements in the certification are current and correct). Please note there are civil and criminal penalties associated with supplying false or misleading information. A false certification will result in the device entry being removed/cancelled from the ARTG.
• Select 'Validate'.
• 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'
• Your application will be submitted electronically.
• 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 in TBS to the individual you have nominated to have a financial role.
• Pay the relevant application fee.

What happens next?

Once your application fee is paid, your Class I export only medical device application / Class 1 IVD export only medical device application will be either included in the ARTG or selected for audit. We may perform an audit of your application if the information provided suggests:

• The product included in your application does not meet the definition of a medical device
• The product included in your application is excluded from inclusion in the ARTG under subsection 7AA of the Act
• Not all declarations you made under section 41FD of the Act appear to be correct, for example the medical device included in your application does not appear to be correctly classified or compliant with the requirements of the Essential Principles.

Invitation to provide feedback

We invite sponsors of Class I medical devices and Class 1 IVD medical devices to provide their feedback on the changes made to the process for including Class I non-sterile, non-measuring medical devices, Class 1 IVD medical devices, and Class I Export Only and Class I IVD Export Only medical devices in the ARTG by answering a survey. Send an email for more details to devices@tga.gov.au(link sends e-mail)