TGA Medical Device Classification: Risk Classes, IVDs and Conformity Assessment
TGA classification of medical devices under Therapeutic Goods (Medical Devices) Regulations 2002: Class I, IIa, IIb, III, AIMD, IVD Class 1-4, ARTG inclusion.
Legislative framework
Medical devices in Australia are regulated by Chapter 4 of the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods (Medical Devices) Regulations 2002. The Act defines a 'medical device' broadly, encompassing instruments, apparatus, software and implants intended for a medical purpose. Therapeutic Goods Act sponsor obligations outline responsibilities for those involved.
Section 41BE of the Act establishes the Essential Principles that all medical devices must meet to be included in the Australian Register of Therapeutic Goods (ARTG). Schedule 2 of the Regulations details the classification rules used to categorise general medical devices and In Vitro Diagnostics (IVDs).
Before lawful supply in Australia, medical devices must be included in the ARTG under section 41MI of the Act. Failure to comply can result in penalties, including imprisonment of up to 5 years or a fine of up to 4,000 penalty units.
General medical device classes
Medical devices in Australia are categorised into risk classes to determine the appropriate regulatory controls. Class I devices are considered low risk, encompassing items such as non-sterile bandages, surgical gloves, and walking aids. Some Class I devices, including those with a measuring function or those supplied sterile, are subject to specific conformity assessment routes. Therapeutic Goods Advertising Code governs how these and all medical devices are advertised.
Devices with a low-medium risk profile are classified as Class IIa, examples including hypodermic needles and suction equipment. Devices presenting a medium-high risk are designated Class IIb, and include items such as lung ventilators, bone fixation plates, and infusion pumps. The highest risk category, Class III, covers devices such as heart valves, implantable defibrillators, and devices containing medicinal substances or animal tissue.
A separate, high-risk category exists for Active Implantable Medical Devices (AIMD). This category includes devices such as pacemakers and cochlear implants. Therapeutic Goods Advertising Code applies to the advertising of AIMDs as it does to all medical devices.
In Vitro Diagnostic (IVD) classes
In vitro diagnostic (IVD) devices are regulated as medical devices and classified according to risk. These classifications range from Class 1 to Class 4, reflecting the level of individual and public health risk associated with the device. Class 1 IVDs are considered to have a low individual and low public health risk, while Class 4 IVDs present a high individual and high public health risk.
Examples of Class 1 IVDs include specimen receptacles and general laboratory reagents. Class 2 IVDs present a low individual and moderate public health risk, such as pregnancy self-tests. Class 3 IVDs are characterised by a moderate individual and high public health risk, encompassing items like HIV self-tests and blood grouping reagents. Tests to detect HIV, Hep B/C in donated blood are examples of Class 4 IVDs.
Self-tests, which are IVDs intended for home or self-use, generally classify at a higher risk level than equivalent tests designed for professional use. This reflects the increased potential for misuse or misinterpretation when performed outside of a clinical setting.
Conformity assessment and ARTG inclusion
Manufacturers seeking inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG) must first demonstrate conformity assessment with the Essential Principles (section 41BE). This assessment can be conducted by the TGA itself, a Medical Device Single Audit Program (MDSAP) auditing organisation, or an EU Notified Body, where applicable under mutual recognition arrangements.
The level of conformity assessment required varies depending on the device’s risk classification. Class I (non-sterile, no measuring function) and Class 1 IVDs can utilise a manufacturer’s declaration of conformity. Devices in higher-risk classes, including IIb, III, Active Implantable Medical Devices (AIMD), Class 3 and Class 4 IVDs, generally require independent conformity assessment, which includes technical file review.
Regardless of classification, all medical devices listed in the ARTG are subject to post-market surveillance. This includes obligations such as adverse event reporting under Regulation 5.7 and the requirement to notify the TGA of any recalls.
Frequently asked
How are medical devices classified by the TGA?
General medical devices are classified as Class I, Class IIa, Class IIb or Class III, with Active Implantable Medical Devices (AIMD) treated as a separate high-risk category. In Vitro Diagnostic (IVD) devices are classified into Classes 1-4. Classification is based on the rules in Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 and considers intended use, duration of contact, degree of invasiveness and public health risk.
What is conformity assessment and who can perform it?
Conformity assessment is the process of demonstrating that a medical device complies with the Essential Principles under section 41BE of the Therapeutic Goods Act 1989. Depending on the device class, assessment can be conducted by the TGA, an MDSAP-recognised auditing organisation, or, for certain procedures, an EU Notified Body. Class I (non-sterile, without measuring function) and Class 1 IVDs can rely on a manufacturer's declaration of conformity.