Classification of medical devices
Australian medical devices guidelines
Guidance document number 25
This guidance document is one of a series that has been produced to help explain the new regulatory system for medical devices in Australia that commenced on 4 October 2002. The new system has been established by the Therapeutic Goods Act 1989 as amended by the Therapeutic Goods Amendment (Medical Devices) Bill 2002 and the Therapeutic Goods (Medical Devices) Regulations 2002.
The risks associated with using medical devices can range from little or no risk to patients and users to significant potential risks inherent in the type of device. The level of premarket intervention by the regulator is proportional to the level of potential risk and is established through a classification system based on that potential risk.
This document provides guidance on the classification rules for medical devices.
Australian medical devices guidelines: 25. Classification of medical devices (pdf,180kb)
Contents
- Disclaimer
- Further information
- Amendment schedule
- Introduction
- Purpose
- Background
- The classes of medical devices
- The classification rules
- Classifying a medical device
- Flowchart 2 Classification Rules - non invasive devices
- Flowchart 3 Classification rules - invasive devices
- Flowchart 4 Classification rules - active devices
- Flowchart 5 Classification rules - special rules
- Appendix A - Definitions