Class I medical device registration with the Australian TGA does not require an annual review in the same way that higher-risk devices (Class II and above) do. However, there are some ongoing obligations:

Ongoing Obligations After Registration

1. Annual Listing Fee: While there is no formal annual review of the device, manufacturers must pay an annual ARTG listing fee (around AUD 1,080) to maintain the registration of their Class I medical device.

2. Post-Market Surveillance: Manufacturers are required to monitor the safety and performance of their devices once they are on the market. This includes:

   • Reporting any adverse events or incidents related to the device to the TGA.
   • Keeping technical documentation up to date and available for TGA audits.

3. Compliance with Essential Principles: Manufacturers must continue to ensure that their devices comply with the Essential Principles of safety and performance throughout the device’s lifecycle.

4. Change Notifications: If there are significant changes to the device, such as modifications in design, materials, or intended use, manufacturers may need to notify the TGA and potentially update their registration.

Summary

While there is no formal annual review process for Class I medical device registration, manufacturers have ongoing responsibilities to ensure compliance, report adverse events, and maintain their ARTG listing through the annual fee.

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