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Medical device inclusion process
Steps in the process
Step 5 - 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:
- Select 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.
For Class I medical device export only and Class 1 IVD medical device export only applications you are not required to attach or add supporting information.
- 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). Please note there are civil and criminal penalties associated with supplying false or misleading information. A false declaration 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?
Your Class I Medical Device Export Only/Class 1 IVD medical device Export Only application is not reviewed by TGA prior to the device being included in the ARTG.
The automated TBS system will:
- Accept the application.
- Create an inclusion in the ARTG within 24 hours of submission.
- Send you an email advising you of the inclusion of your device in the ARTG.
- Go to Step 8 - Printing your ARTG Certificate of Inclusion and Step 9 - Ongoing responsibilities.