The cycle for Class III medical device registration with the Therapeutic Goods Administration (TGA) in Australia can vary based on several factors, including the complexity of the device, the completeness of the application, and the efficiency of the review process. However, the overall timeline can be outlined as follows:

General Timeline

1. Preparation Phase (3 to 12 months or more):

   • Documentation and Clinical Studies: Preparing the necessary documentation, conducting clinical evaluations, and possibly running clinical trials can take several months to over a year. The time required will depend on the complexity of the device and the data needed to support safety and efficacy.
   • Quality Management System (QMS): If the manufacturer does not already have an established QMS that complies with ISO 13485, implementing this system can also add time to the preparation phase.

2. Application Submission:

   • Submitting Application: Once the application and all supporting documents are prepared, the manufacturer submits the application through the TGA's online portal. This step itself does not take long but depends on the readiness of the documentation.

3. TGA Review Process (6 to 12 months):

   • Initial Assessment: The TGA conducts an initial review to verify the completeness of the application, which may take a few weeks.
   • Conformity Assessment by Notified Body: For Class III devices, the TGA collaborates with a TGA-recognized Notified Body for the conformity assessment. This process can take 3 to 6 months or more, depending on the Notified Body's workload and the complexity of the device.
   • Additional Information Requests: If the TGA or Notified Body requires further information or clarification, this can extend the review process. The time taken to respond to such requests can vary.

4. Decision and Registration (1 to 2 months):

   • Approval Notification: After the review is completed, the TGA will issue a decision. If approved, the device is registered in the Australian Register of Therapeutic Goods (ARTG). This part of the process usually takes about a month.

Total Estimated Timeline

• Overall Cycle: The total time from the beginning of preparation to registration can range from 6 months to 2 years or more, depending on the complexity of the device, the thoroughness of the application, and any additional requirements or queries that arise during the review process.

Factors Influencing Timeline

• Complexity of the Device: More complex devices that require extensive clinical data may take longer to prepare and review.
• Completeness of Application: A well-prepared application with complete and clear documentation will likely lead to a faster review process.
• Regulatory Changes: Any changes in TGA regulations or procedures may impact timelines.
• Workload of Notified Body and TGA: The current workload and capacity of the Notified Body and TGA also play a crucial role in determining the speed of the review process.

Conclusion

Overall, manufacturers should plan for a significant timeline when preparing for Class III medical device registration with the TGA, with the understanding that thorough preparation and clear documentation can help streamline the process.

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