Therapeutic Goods Administration (TGA) Australia has published the first version of the guidance document on the classification of active medical devices (including software-based medical devices) in October 2021.
The guidance document will act as a reference and will assist manufacturers of active medical devices, including software-based medical devices, in correctly classifying their devices. In general, medical devices are categorised according to the level of harm that may be inflicted upon the users or patients.
Class I (lowest classification), Class IIa, Class IIb, and Class III (highest classification) are the classifications for medical devices. The rules for the classification are applied according to the device’s mechanism and its intended purpose (in accordance with the manufacturer’s vision and consideration). For complex medical devices with many functions, the device will have to be categorized according to the highest applicable level.
A part of the definition for active medical device mentions that it is a medical device intended by its manufacturer to depend on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity) for its operation; and to act by converting this energy.
The classification rules that are applicable for active medical devices are grouped into firstly, detecting, diagnosing, screening, monitoring and investigation. Next is therapy, recording patient images and anatomical models, and medical devices intended for contraception or prevention of sexually transmitted diseases. The final rule is the general rule for any other active medical device.
More details can be found in “Classification of active medical devices (including software-based
medical devices), Version 1.0, October 2021”: https://www.tga.gov.au/sites/default/files/classification-of-active-medical-devices-including-software-based-medical-devices.pdf