Withdrawing Your Medical Device or IVD ARTG Application – TGA Guidelines

Reasons for Withdrawing an Application

Sponsors may choose to withdraw a pending ARTG application for various reasons, such as:

• Change in commercial strategy or decision not to market the device/IVD in Australia.
• Identification of significant issues during preparation or TGA feedback that make approval unlikely or uneconomical.
• Delays in development, testing, or obtaining supporting data.
• Corporate restructuring, merger, or transfer of product rights.
• Preference to submit a revised or new application later.

Withdrawal is entirely voluntary and does not prevent future re-submission (though a new application would be required). Source: Withdraw your ARTG application - TGA

When Withdrawal is Possible

• Withdrawal can be requested at any stage before the TGA makes a final decision on the application (approved, rejected, or withdrawn by TGA).
• It is not available once a decision has been made.
• For applications under review, withdrawal stops the assessment process immediately upon acceptance.

How to Withdraw an Application

1. Prepare Notification:

   • Submit a written request clearly stating the intent to withdraw.
   • Include:
     • ARTG application reference number.
     • Device/IVD name and description.
     • Sponsor details.
     • Reason for withdrawal (optional but recommended for TGA records).
     • Confirmation that the sponsor understands withdrawal is final and no refund of fees may apply depending on stage.

2. Submission Method:

   • Lodge via the TGA eBusiness Services portal (preferred for tracking).
   • Or email to the relevant TGA device/IVD application mailbox with subject line indicating withdrawal request.
   • No specific form is required; a letter or email suffices.

3. TGA Confirmation:

   • TGA acknowledges receipt and confirms withdrawal.
   • The application status is updated to withdrawn in the system.
   • No further assessment occurs.

Implications of Withdrawal

• Fees: If withdrawal occurs before substantial assessment begins, a partial or full refund may be possible (check current fee policy). After significant review, fees are generally non-refundable.
• No Prejudice: Withdrawal does not imply rejection or non-compliance; future applications are unaffected.
• Supply Prohibition: If the device/IVD was never included, no supply is authorised (withdrawal does not change this).
• Records: The application remains on record as withdrawn for transparency and future reference.

Practical Advice

• Notify early to maximise potential fee refund and avoid unnecessary assessment costs.
• For complex or high-value applications, consider pre-submission consultation to resolve issues instead of withdrawal.
• Coordinate with any Australian sponsor or authorised representative if applicable.

The TGA provides detailed instructions, including contact details for submission, fee refund policy references, and examples of withdrawal wording in the official user guide on withdrawing your ARTG application. Source: Withdraw your ARTG application - TGA

This process offers sponsors flexibility to manage regulatory submissions efficiently while maintaining accurate ARTG records for medical devices and IVDs in Australia.