To apply for Class IIa medical device registration with the Australian Therapeutic Goods Administration (TGA), the entire process is conducted through the TGA Business Services (TBS) portal. Below is a detailed guide on how to apply and where to process it.

Steps to Apply for Class IIa Medical Device Registration

1. Set Up a TGA Business Services (TBS) Portal Account

• Where: You will use the TGA Business Services (TBS) portal to submit your application.
  • Visit the TGA Business Services Portal at: TGA Business Services
• Account Setup: If you do not already have an account:
  • Register as either a sponsor (if you are an Australian entity) or as an overseas manufacturer (with an appointed Australian sponsor).
  • Sponsors must have an Australian Business Number (ABN) and be authorized to act on behalf of the manufacturer if you are submitting the application on their behalf.

2. Prepare Required Documents

Ensure you have all the necessary documents ready before you start the application. This includes:

• Manufacturer’s Evidence: ISO 13485 certification or conformity assessment certificate (such as CE marking).
• Technical Documentation: Comprehensive information about the device’s safety, performance, risk management, clinical data, and labeling.
• Essential Principles Checklist: Demonstrating compliance with Australian regulatory requirements.
• GMDN Code: The correct Global Medical Device Nomenclature (GMDN) code for your device.
• Labeling and Instructions for Use (IFU): Detailed, compliant labeling and IFU for the device.

3. Submit the Application through the TBS Portal

Once you have access to the TBS portal, follow these steps:

1. Login: Enter your credentials to access your account.
2. Start a New Application:
   • Select "Medical Device" as the application type.
   • Choose the appropriate classification (Class IIa) for your device.
3. Provide Device Information:
   • Enter details such as the device name, GMDN code, and intended use.
   • Upload the manufacturer’s evidence (e.g., CE marking, ISO certification).
4. Attach Technical Documentation:
   • Upload all required documentation, including device descriptions, risk assessments, clinical evaluations, and verification/validation data.
   • Submit the Essential Principles Checklist and demonstrate compliance.
5. Pay the Application Fee:
   • Fees must be paid online through the TBS portal when submitting the application.
   • The fees vary depending on the type of device, the need for conformity assessment, and other factors.

4. Review and Respond to TGA Requests

• After submission, the TGA will begin reviewing your application. This review process can vary depending on whether the device has been approved by other regulatory bodies (e.g., the EU or US FDA).
• TGA Review Process:
  • If the device has international certification, the review may be streamlined.
  • If a full conformity assessment is required, the TGA may request additional documentation or clarification.
• Monitoring the Application: You can track the status of your application via the TBS portal and respond to any additional requests from the TGA.

5. ARTG Inclusion

• Upon successful review, the device will be added to the Australian Register of Therapeutic Goods (ARTG), and you will receive confirmation of the inclusion.
• Once included, the device can be legally marketed and sold in Australia.

Where to Process the Application

All applications for Class IIa medical device registration are processed through the TGA Business Services (TBS) portal, which is the central platform for interacting with the TGA. The portal allows for:

• Submission of applications for medical device registration.
• Tracking and monitoring of application status.
• Payment of fees related to the application.
• Correspondence with the TGA regarding any questions or requests for additional information.

The TGA Business Services Portal is available online at:
TGA Business Services Portal

Summary of the Key Steps:

1. Create a TBS portal account (or work with an Australian sponsor if you are an overseas manufacturer).
2. Prepare the necessary documentation, including technical files, risk management data, and clinical evaluations.
3. Submit the application via the TBS portal, along with supporting documents and fees.
4. Monitor the application process and respond to any TGA requests for additional information.
5. Once approved, your device will be included in the ARTG, allowing you to market the device in Australia.

This streamlined process ensures that you follow Australian regulatory requirements for medical device registration.