What is a Medical Device (TGA Definition)?
The Australian Therapeutic Goods Authority (TGA) defines a medical device as an instrument apparatus, appliance, material or other article intended to be used for human beings:
- diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability
- investigation, replacement or modification of the anatomy or of a physiological process
- control of conception
Benefit verses Risk Approach.
Both the TGA and Medsafe (NZ regulator) regulate and classify Medical Devices and IVD's on a risk verses benefit approach. The risk vs benefit approach takes into consideration:
- Intended use of the device
- Risk to patient, carer or health care professional,
- Degree of invasiveness in the body
- Duration of use
The higher the risk, the higher the classification and the more rigorous the regulatory requirements.
Classification of Medical Devices
The classification levels in Australia and New Zealand are modeled on the European system:
Low Risk-
- Class I
- Class I—supplied sterile
- Class I—incorporating a measuring function
Low to Medium Risk-
- Class IIa
Medium to High-
- Class IIb
High Risk-
- Class III
- Active implantable medical devices (AIMD)
