TGA Draft Guidance and Essential Principle 13B Updates

The TGA released updates on two important guidances. The first is a draft guidance consolidating various documents to assist with regulatory compliance in Australia,and the second update pertains to Essential Principle 13B:

1. TGA Guidance – Regulation of software based medical devices

The TGA have created a guide in relation to the regulation of software based medical devices including software as a medical device (SaMD) in February 2021. This guidance “Regulation of software based medical devices” provides a summary of changes to the regulation (excluded software, clinical decision software, cybersecurity for users and industry, classification of active medical devices) and any transitional arrangements available for devices that may need to be reclassified.

Topics include:

• • Baby movement apps
  • Communications program (webinars and regulatory discussion sessions)
  • Regulation of Digital Therapeutics (DTx)
  • International regulatory activities
  • Risks of harm
  • Artificial intelligence chat, text and language

2. TGA Essential Principle 13b guidance – transitional deadline approaching

EP 13 is regarding the information to be provided with medical devices and EP 13B in particular relates to Software – version numbers and build numbers in order to improve traceability in relation to device specific adverse event signals and in post-market surveillance. EP 13 was introduced requiring the current version and build number to be accessible and identifiable to the users of medical devices that are software or incorporate software.

TGA allowed a transitional period for medical devices to meet EP 13B that were already included in ARTG and please note this deadline is November 2024.

Essential Principle 13B guidance will assist you on how to comply with the new essential principle. You can read the full document on the TGA website here.

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Reach out to our regulatory team here if you have any questions or need help understanding the latest TGA essential principle 13b and draft guidance update for regulation of software based medical devices.

Learn how MedEnvoy can assist you:

• • Australian TGA Sponsor
  • RA Consulting
  • QA Consulting