To apply for the registration of Class IIa medical devices with the Australian Therapeutic Goods Administration (TGA), the application must be submitted through the TGA Business Services (TBS) portal. This online platform is the official channel for submitting applications, managing accounts, and communicating with the TGA regarding medical device registration.

Here’s a step-by-step guide on where and how to apply:

1. Register with the TGA Business Services (TBS) Portal

The TGA Business Services (TBS) portal is the central hub for submitting applications. If you are an Australian sponsor or an overseas manufacturer, you (or your sponsor) must first register an account on this portal.

How to Access the TBS Portal:

• Visit the TGA Business Services portal: TGA Business Services Portal
• If you do not have an account, you will need to register for an account.

Account Registration Requirements:

• Australian Business Number (ABN): If you're an Australian entity or sponsor, you’ll need an ABN to complete the registration.
• Authorized Representative: The person registering the account must be authorized to act on behalf of the company or manufacturer.
• Overseas manufacturers must appoint an Australian sponsor before applying.

2. Submit the Application

Once you have access to the TBS portal, you can begin the application process for including your Class IIa medical device in the Australian Register of Therapeutic Goods (ARTG).

Steps to Submit an Application:

1. Login to the TBS Portal: Use your registered account details.
2. Submit Manufacturer’s Evidence: If you have conformity assessment certification (e.g., CE mark), submit evidence of this certification.
3. Select the Application Type: Choose "Medical Device Application" and select the appropriate device classification (Class IIa).
4. Provide Device Details: Enter details such as the device name, Global Medical Device Nomenclature (GMDN) code, intended use, and risk class.
5. Attach Supporting Documents: Upload required technical documentation, including risk management, clinical evidence, and labeling information.
6. Pay Application Fees: Fees for the application process must be paid online at the time of submission.

3. Monitor the Application

After submitting the application, the TGA will review the submitted materials. You can monitor the status of your application and respond to any requests for additional information via the TBS portal.

The TGA will communicate with the sponsor (or manufacturer) regarding any next steps, including any further documentation required or updates on the review status.

4. Application Assistance

If you need help during the submission process, the TGA provides resources and guidance on their website. You can also contact the TGA’s Device Applications Section for support:

• TGA Contact: Contact the TGA
• Guidance Documents: Refer to the TGA guidance documents for step-by-step instructions on the application process and regulatory requirements: TGA Medical Device Guidance.

Key Takeaways:

• Where to Apply: Applications are submitted via the TGA Business Services (TBS) portal.
• Requirements: You need an account with the TBS portal, either as a sponsor or a manufacturer, and you must provide detailed technical documentation and supporting evidence for the device.
• Fees: Application fees are paid at the time of submission through the portal.

For more details and access to the TBS portal, visit the TGA website at TGA Business Services.

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