The regulation of medical devices in Australia is fundamentally risk-based; however, rules and classifications differ significantly between In Vitro Diagnostic (IVD) devices and non-IVD medical devices. Manufacturers must understand their product category, as this dictates the entire regulatory pathway.
A non-IVD medical device is any device not primarily relying on in vitro examination of human specimens for diagnosis or clinical management. Learn more about it here.
Intended Purpose and Risk
The core distinction lies in the intended purpose.
- IVD devices gather information from samples from the body (e.g., blood tests). Their risk classification (Classes 1–4) is based on the consequence of an incorrect result.
- Non-IVD medical devices (e.g., pacemakers, surgical tools) interact with or within the human body. Their risk classification is based on factors like invasiveness, duration of contact, and energy sources. This ensures that high-risk items undergo greater scrutiny than low-risk items.
Classification Rules and System Packs
The classification rules for non-IVD medical devices are outlined in Schedule 2 of the TGA’s regulations. The classification factors determine the rigour of the conformity assessment. Note that if a system pack combines both IVD and non-IVD devices, the entire pack is classified according to the highest risk device within it.
Mastering the Regulatory Complexity
Understanding the Australian medical device regulatory approval pathway, including the regulatory standards surrounding non-IVD requirements, can be complex. Ensure your device’s classification and compliance documentation are managed by regulatory affairs professionals who specialise in the TGA framework.