Transition Period for New Software-Based Medical Device Rules Ending Soon

The Therapeutic Goods Administration (TGA) recently updated the links and guidance template for software-based medical devices. This serves as a crucial reminder for sponsors, particularly those with applications submitted before February 25, 2021.

Key Points for Sponsors:

• Transition Period Ending: The transition period for complying with the new classification rules for software-based medical devices concludes on November 1, 2024.
• Who Needs to Comply: This applies to all applications submitted before February 25, 2021. These devices may require reclassification under the new regulations.
• New Regulations: Introduced on February 25, 2021, the changes encompass programmed and programmable medical devices, along with all software-based medical devices.
• New Applications: All applications submitted after February 25, 2021, already adhere to the new classification rules.
• Reclassification and Transition: If the updated regulations require reclassifying your existing software-based medical device, you can leverage the transition arrangements. These arrangements allow continued supply of the device while you submit a new application for inclusion in the Australian Register of Therapeutic Goods (ARTG) under the new classification.

Taking Action:

Sponsors with applications submitted before February 25, 2021, should:

• Review the updated TGA guidance to ensure their devices comply with the new classification rules.
• If reclassification is necessary, utilize the transition arrangements to maintain supply while seeking ARTG inclusion under the new classification.

The figure below provides a clear overview of the timeline for this transition period and the important dates.

 

 

TGA Clarifies Software Exclusions and Exemptions

The Therapeutic Goods Administration (TGA) also released a new guidance to help sponsors, manufacturers, and software developers understand which software products are regulated and which are not. This is important information, as it can impact development, marketing, and oversight.

Key Points:

• Exclusions vs. Exemptions: The guidance clarifies the distinction between exclusions (completely unregulated) and exemptions (some TGA oversight remains, like advertising and adverse events).
• Software Not Regulated: There are 15 specific types of software excluded from regulation, including those for:
  • Consumer health (prevention, management, follow-up)
  • Telehealth and remote diagnosis
  • Digital mental health tools
  • Digitizing paper-based clinical data
  • Population-based analytics
  • Laboratory information management systems

What to Do:

• Excluded Software: If your product meets an exclusion's conditions, it's exempt from TGA regulation and shouldn't be included in the Australian Register of Therapeutic Goods (ARTG). No further action on registration is required with the TGA for that software.

• Regulated Software: If your software meets the definition of a medical device and doesn't qualify for an exclusion, it will be subject to TGA regulation. Unless the product qualifies for an exemption, you'll need to apply for registration on the ARTG before marketing, selling, or distributing it in Australia.

Multiple Functions:

The guidance emphasizes that software with multiple functions may only be excluded if all functions meet the exclusion criteria. The same applies to the exemption for clinical decision support systems (CDSS).

Action:

Software developers and manufacturers should review the updated TGA guidance to determine if their products fall under an exclusion or exemption category. This can help ensure compliance and avoid unnecessary regulatory hurdles.

 

 

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Connect with us today here to unlock your medical device potential. 

 

 

References

For more information on the two guidance documents in this article kindly refer to the following TGA resources:

• Regulatory changes for software based medical devices version 1.3
• Excluded software Interpretation of software exclusion criteria version 1.0