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Medical device inclusion process
Steps in the process
Step 3 - Accessing TGA business services
You will need to have a Client ID and access to the TBS website in order to submit your medical device application.
Applying for a Client ID
If you are a first time applicant and you do not have a Client ID, you need to apply to register your details with the TGA by completing and submitting the Organisation details form in TBS.
The TGA will then issue you with a Client Identification number.
Your Client Identification number will be used in all your application forms.
Ensure that you only nominate persons on your organisation details form who you authorise to undertake business/regulatory correspondence with us on your behalf as we will only engage in business/regulatory correspondence with those persons. You will also need to ensure that the details of authorised persons on your account remain current at all times.
Updating your client details
TBS is our primary method of communicating with you. You should ensure that your client details are up-to-date at all times, particularly in relation to:
- your postal and email address,
- your company contact phone number and your mobile phone number, and
- the person(s) you authorise to be your representative or agent.
More information about keeping your information current can be found on the:
Where to next?
Once you have TBS access, and your details are up to date:
- for Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices go to Step 4 - Submitting an application in TBS for Class I non-sterile, non-measuring and Class 1 IVD medical devices
- for Class I medical device/Class 1 IVD medical device Export Only go to Step 5 - Submitting an application in TBS for Class I Medical Device (Export Only) and Class 1 IVD Medical Device (Export Only)
- for all other medical devices go to Step 6 - 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)