Australian Medical Device Classification: TGA Risk-Based System

Australian Medical Device Classification: TGA Risk-Based System

The Therapeutic Goods Administration (TGA) in Australia classifies medical devices based on their potential risk to the patient and user. This risk-based classification system, which includes Class I, IIa, IIb, III, and Active Implantable Medical Devices (AIMD), is foundational, as it dictates the level of regulatory scrutiny, the required Conformity Assessment evidence, and the complexity of the registration process for inclusion in the Australian Register of Therapeutic Goods (ARTG).

The classification is determined by the device's:

1. Intended Use.
2. Level of Invasiveness.
3. Duration of Use.
4. Dependence on an energy source.

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TGA Device Classification and Risk Levels

Device Class	Risk Level	Description & Examples
Class I	Low Risk	Typically non-invasive and do not sustain or support life. Most Class I devices can be self-assessed. Examples include bandages, examination gloves, and tongue depressors.
Class IIa	Low to Moderate Risk	Devices presenting a low to moderate risk, often involving short-term invasive use. Examples include dental fillings, hearing aids, and contact lenses.
Class IIb	Moderate to High Risk	Devices associated with moderate to high risk, potentially involving long-term use or significant invasiveness. Examples include infusion pumps, ventilators, and bone fixation plates.
Class III	High Risk	Devices that pose the highest risk, are often life-sustaining or life-supporting, or are permanently implanted. Examples include heart valves, pacemakers, and deep brain stimulators.
AIMD	Highest Risk	Active Implantable Medical Devices, such as implantable pacemakers or defibrillators, are subject to the strictest controls.

In Vitro Diagnostic Devices (IVDs)

IVDs are classified separately, also based on risk, for their use in examining samples from the human body for diagnostic information. Examples include blood glucose meters, pregnancy tests, and Polymerase Chain Reaction (PCR) test kits.

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Regulatory Impact of Classification

The assigned classification directly influences the manufacturer's obligations:

• Conformity Assessment: Higher-risk classes (IIb, III, AIMD) require more extensive evidence of compliance with the Essential Principles (the TGA's safety and performance requirements). For Class IIb and Class III, this often involves a mandatory TGA application audit.
• Quality Management System (QMS): All manufacturers must implement and maintain a QMS compliant with ISO 13485:2016 standards.
• Registration Pathway:
  • Standard Class I: Most can be included in the ARTG with minimal documentation.
  • Special Class I (Sterile or Measuring Function): These devices require additional conformity assessment documentation despite their low-risk classification.
  • Class IIa, IIb, III, AIMD: Require formal Conformity Assessment Certificates (often relying on international approvals like EU or FDA) and a full registration submission by an Australian Sponsor.