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Medical device inclusion process

Steps in the process

11 October 2019

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Step 7 - Processing your application

Once you have submitted your application and paid the associated application fee, we will assess your application resulting in one of the following outcomes:

  • The application is refused if it fails to pass the preliminary assessment
  • The kind of medical device is included in the ARTG
  • The application has been selected for audit
  • Withdrawal of your application as per your request

Note

You will be notified about the decision within 20 working days after the day when your application fee was paid.

The application is refused

Your application fails preliminary assessment if:

  • it is not made in accordance with a form and manner approved for classification of a medical device or IVD medical device;
  • the application fee is not paid;
  • the application is not accompanied by the kind of information prescribed for the application of this classification by legislative instrument and provided in an approved form;
  • the device must have a TGA conformity assessment certificate and a TGA conformity assessment certificate is not in force; or
  • the application contains information that is false or misleading.

What happens next?

You will receive written notification outlining that your application is refused and the reasons why your application has failed preliminary assessment.

Any fees paid will not be refunded and cannot be transferred/credited to a new application submitted at a later stage. For further information refer to the refunds web page.

You cannot supply the kind of medical device as it has not been included in the ARTG.

You can resubmit a new application and recommence the process at any time.

The application has been selected for audit

In some instances your application will be selected for audit. You can find more information about how medical device and IVD medical device applications are selected for audit at Auditing of medical device, including IVD medical device, applications.

What happens next?

You will be notified if this occurs and asked to provide further information and supporting documentation and if applicable you will receive an invoice for the assessment fee.

The information provided in and with the application will be assessed.

Further information on Auditing of medical device and IVD medical device applications is available on our website.

The decision is made to include the kind of medical device in the ARTG

You will receive an automated email advising that your application has been successful.

What happens next?

You can supply the kind of medical device as it has been included in the ARTG.

Go to Step 8 - Printing your ARTG Certificate of Inclusion and Step 9 - Ongoing responsibilities

Withdrawal of your application

You may withdraw your application at any time prior to a decision being made whether or not to include the medical device, or IVD medical device, in the ARTG. If you wish to withdraw your application, you can do so through TBS.

Note

Any fees you have paid will not be refunded if you withdraw your application.

What happens next?

You will receive an email confirming that your medical device, or IVD medical device, application has been withdrawn.

You cannot supply the kind of medical device as it has not been included in the ARTG.

You can resubmit a new application and recommence the process at any time.

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