Australia TGA medical device classification

The Therapeutic Goods Administration (TGA) in Australia regulates medical devices through a classification system based on the level of risk associated with their use. The classification system for medical devices in Australia is divided into four main classes: Class I, Class IIa

The TGA’s risk-based classification framework ensures that each medical device undergoes the appropriate level of regulatory oversight before it can be supplied in the Australian market. Factors such as the device’s intended use, level of invasiveness, duration of contact with the body, and overall risk to patient health determine its classification. As the risk increases, so do the regulatory requirements, including evidence of safety, clinical performance, and compliance with the Essential Principles.

In Australia, manufacturers must provide detailed technical documentation, quality management system (QMS) certification, and, where applicable, clinical evidence based on the device class. Higher-risk devices such as Class IIb and Class III require assessment by the TGA or a recognized conformity assessment body, while lower-risk devices follow a simplified pathway. This structured regulatory process helps ensure patient safety, supports high-quality product development, and facilitates efficient market access for medical device companies.