Processing Duration: Once you submit your application through the TGA Business Services (TBS) portal, the processing is generally quick due to the self-declaration nature of Class I devices, which do not require a detailed pre-market review.

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.

Registration ensures that the medical device complies with Australian laws and regulations governing the safety and efficacy of therapeutic goods. It is a legal requirement for marketing and supplying medical devices in Australia.

The registration process for Class I devices usually takes a few days to a few weeks from the time of submission to the TGA.

Class I devices are considered low-risk and typically include items like bandages, non-invasive diagnostic tools, and simple surgical instruments.

Ensure your device qualifies as a Class I medical device. Class I devices are considered low-risk, such as simple non-invasive instruments or products like bandages. Review the Australian Therapeutic Goods (Medical Devices) Regulations 2002 for classification guidelines.

Class I devices are low-risk medical devices, such as bandages or simple diagnostic tools. Use the Australian Therapeutic Goods (Medical Devices) Regulations 2002 to confirm that your device is indeed Class I.

Class I medical devices are low-risk devices, such as bandages or simple non-invasive devices.