To apply for TGA (Therapeutic Goods Administration) registration of Class IIb medical devices in Australia, you need to submit your application through the TGA Business Services (TBS) portal. The TGA Business Services portal is the online platform where all medical device applications are processed.

Steps to Access and Apply via the TGA Business Services Portal

1. Register for a TGA Business Services Account

   • If you don’t already have an account, you will need to register for one on the TGA Business Services portal.
   • Link: TGA Business Services Portal
   • During registration, you will need to provide business details, including your Australian Business Number (ABN), if applicable, and other relevant information.

2. Login to the Portal

   • Once registered, log in to your account using your credentials.

3. Prepare Your Application

   • Gather all the necessary documentation for your Class IIb device, including:
     • Technical documentation.
     • Conformity assessment reports.
     • Clinical evidence.
     • Labeling and instructions for use (IFU).
   • Ensure all documentation is ready for submission in the correct format.

4. Submit an Application

   • Use the Medical Device Application (MDAN) form to submit your application for registration.
   • Choose the appropriate application type and fill in the required details. Upload the required documents as part of the application.

5. Pay Fees

   • Once the application is submitted, you will be prompted to pay the necessary application fees. Payment is done through the TBS portal.

6. Track Application

   • After submission, you can track the status of your application through the TBS portal. You may also receive requests from the TGA for additional information or clarifications, which should be addressed promptly.

Additional Resources

• TGA Business Services Helpdesk: If you have any issues with the portal or need assistance, you can contact the TGA Business Services Helpdesk for support.
• TGA Guidelines: Review the Medical Device Regulatory Framework and other relevant guidelines on the TGA website to ensure you are fully prepared.

By using the TGA Business Services portal, you can manage the entire process of applying for Class IIb medical device registration, from initial submission to approval and post-market obligations.