The time to obtain Class I medical device registration with the Australian Therapeutic Goods Administration (TGA) typically ranges from a few days to a few weeks after submission. Here are the key factors influencing the timeline:

Typical Time Frame

• 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.

Factors Affecting Processing Time

1. Completeness of Application: Ensuring that all required documentation (e.g., Declaration of Conformity, device description) is accurate and complete can help speed up the process. Missing or incorrect information can cause delays.

2. TGA Workload: The processing time may vary based on the TGA’s current workload and the volume of applications being handled.

3. TGA Client ID: If you or your sponsor do not have a TGA Client ID, the time taken to obtain one can also extend the overall timeline.

Summary

In summary, you can expect the registration process for a Class I medical device to take between a few days and a few weeks, depending on the completeness of your application and the TGA’s workload.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn