In this article
What software may controlWhy changes need reviewCybersecurity and update authenticityHow to find the correct versionExample: putting the information in contextWhat to check nextFrequently asked questionsCan firmware affect the medical device’s intended performance?Should users install community modifications?Read more on this topicOfficial sourcesRelated articles
Software and firmware can affect a medical device’s performance even when its housing remains unchanged. Updates should be understood as controlled technical changes, not simply new features.
What software may control
Electronic devices may use embedded software to monitor sensors, regulate heating, display warnings, enforce limits or manage power. Errors can affect safety, device behaviour and the accuracy of displayed information.
Why changes need review
A firmware revision can alter temperature control, alarm behaviour, charging logic or user interactions. Manufacturers must evaluate relevant risks and determine whether changed evidence, documentation or regulatory submissions are needed.
Cybersecurity and update authenticity
For connected or updateable medical devices, integrity of update delivery and security controls can matter. Install only updates provided through verified manufacturer channels and follow official instructions; do not sideload unofficial firmware to bypass safety restrictions.
How to find the correct version
Check the device’s model, displayed software version where available, manufacturer release information and any relevant safety notices. If a change seems to cause unexpected behaviour, stop using the device if unsafe and contact the appropriate supplier or health professional.
Example: putting the information in context
After an official update, the temperature display behaves differently. This should be documented and assessed by the manufacturer; it is not appropriate for a patient to install an unverified “rollback” found in a forum.
What to check next
- Read official manufacturer release notes for the exact model.
- Avoid unauthorised firmware installations or modifications.
- Report unexpected operation through verified safety and supplier channels.
Frequently asked questions
Can firmware affect the medical device’s intended performance?
Yes. Software may be part of safety-critical control behaviour.
Should users install community modifications?
Avoid unverified modifications that could undermine intended use or safety controls.
Read more on this topic
- Medical Devices & TGA: topic overview
- Post-market Monitoring of Medical Devices
- Where to Find Official TGA Medical Device Information
Official sources
- TGA — Quality, safety and performance: Essential Principles
- TGA — Draft industry standards guidance for medicinal cannabis vaping devices (7 July 2026)
This educational information is not individual medical advice. It does not establish the regulatory status or suitability of an unidentified device, and must not be read as authorisation to advertise vaping goods to the Australian public.