External Factors Impacting Medical Device Post-Approval Compliance

The Impact of the 3G Network Shutdown on Medical Device Post-Approval Compliance in Australia.

After over two decades of service, 3G networks in Australia were officially decommissioned on October 28, 2024, to make way for faster and more reliable 4G and 5G technologies.

In addition to the impact on 3G-only phones, remote areas, and smartwatches, medical devices are another category that faced significant challenges. Older medical devices and products, such as personal medical alarms, have often relied exclusively on 3G networks for data transmission, making them particularly vulnerable and sparking concerns about medical device post-approval compliance.

This is just one example of a change in the operating environment that can affect the usability and compliance of your medical device.

In this particular case, the TGA, warned that the following medical devices on the Australian Register of Therapeutic Goods (ARTG) could be impacted:

While implantable devices were unlikely to be affected directly, communication to the remote monitoring systems could be impacted and TGA called on users, sponsors and manufacturers to be aware of potential problems.

As per the TGA (Medical Device) Regulations 2002, Sponsors must consistently maintain evidence that their devices comply with the Essential Principles outlined in the TGA (Medical Device) Regulations 2002. This evidence must be readily available throughout the device’s inclusion on the ARTG. Any medical device post-approval compliance issues must be assessed for regulatory impact, with necessary actions taken, such as reporting to the TGA and informing users. In some cases, this can result in a recall of the device.

Further sponsor responsibilities include:

• Reporting adverse events to the TGA
• Reporting overseas regulatory actions
  • Remedial action that arises overseas for devices supplied in Australia.
• Reporting results of investigations of non-conformance to the TGA
• Obtaining information from the manufacturer (when required)
• Maintaining distribution records

Summary

In summary, Sponsors and manufacturers of products included on the ARTG should act promptly to identify potential medical device post-approval compliance issues in the external environment, and take necessary steps to ensure ongoing compliance with the Essential Principles, and patient safety. Staying proactive in addressing these challenges will help mitigate risks and maintain trust in marketed medical technologies.