Applying for Class III medical device registration with the Therapeutic Goods Administration (TGA) in Australia involves a systematic process. Here’s a step-by-step guide on how to apply and where to do it:

Steps to Apply for Class III Medical Device Registration

Step 1: Determine Device Classification

• Confirm that your device qualifies as a Class III medical device based on TGA classification rules.

Step 2: Conduct a Conformity Assessment

• Engage a Notified Body: Since Class III devices are high-risk, you need to obtain a conformity assessment from a TGA-recognized Notified Body.
• This assessment includes a comprehensive review of your device’s design, manufacturing processes, and quality management system.
• Prepare all necessary technical documentation for the Notified Body.

Step 3: Gather Required Documentation

Prepare the following materials to support your application:

1. Device Description: Detailed information about the device, including its purpose, specifications, and intended use.
2. Clinical Evidence: Data demonstrating the safety and effectiveness of the device, including clinical trial results and scientific literature.
3. Risk Management Documentation: A risk analysis following ISO 14971, identifying potential hazards and mitigation strategies.
4. Quality Management System Documentation: Evidence of compliance with ISO 13485, including your quality manual and relevant procedures.
5. Labeling and Instructions for Use: Comprehensive labeling, including usage instructions, warnings, and symbols.
6. Conformity Assessment Report: A report from the Notified Body that details compliance with applicable standards.

Step 4: Create a Business Services Online (BSO) Account

• Register for an Account: Go to the TGA’s Business Services Online (BSO) portal to create an account.
• Access the Portal: TGA BSO Portal.

Step 5: Complete the Application Form

• Application for Inclusion in the Register of Therapeutic Goods (FORM MD): Complete this form through the BSO portal.
• Attach all required documentation.

Step 6: Pay Application Fees

• During the application process, you will be prompted to pay the required fees. Make sure to complete the payment as instructed.

Step 7: Submit Your Application

• Review your application for completeness and accuracy, then submit it through the BSO portal.
• You will receive a confirmation of your submission, including a reference number for tracking.

Step 8: TGA Review Process

• The TGA will review your application, which may take several months. They may contact you for further information or clarification.
• Be prepared to respond promptly to any inquiries.

Step 9: Post-Market Surveillance

• If your application is approved, you will need to implement a post-market surveillance plan to monitor the device’s performance and report any adverse events.

Where to Apply

• TGA Website: Start your application process by visiting the TGA website: TGA Website.
• BSO Portal: The application is submitted online through the Business Services Online (BSO) portal: TGA BSO Portal.

Additional Resources

• Guidance Documents: The TGA provides various guidance documents to assist you in the application process. You can find them on the TGA website under the medical devices section.
• Contact TGA: If you have questions or need assistance, you can contact the TGA through their contact page: TGA Contact Us.

By following these steps and using the resources provided, you can successfully apply for Class III medical device registration with the TGA in Australia.

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