The essential principles for medical devices
Australian medical devices guidelines
Guidance document number 22
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 essential principles set out the requirements relating to the safety and performance characteristics of medical devices. Compliance with applicable medical device standards is not mandatory, but it is one way to establish compliance with essential principles." (section 41C of the Act)
The essential principles may define results to be achieved, performance levels, hazards to be addressed, or issues to be considered, for example, but do not necessarily specify how the principles can be satisfied or complied with. This provides flexibility for manufacturers and caters for technological advances and changes in the application of medical devices.
The essential principles can be divided into two main types:
- general principles - which always apply to all medical devices; and
- particular principles - which only apply to some medical devices.
Australian medical devices guidelines: 22. The essential principles for medical devices (pdf,171kb)
Contents
- Introduction
- Part 1 General principles
- Essential Principle 1 - Use of medical devices not to compromise health and safety
- Essential Principle 2 - Design and construction of medical devices to conform with safety principles
- Essential Principle 3 - Medical devices to be suitable for intended purpose
- Essential Principle 4 - Long term safety
- Essential Principle 5 - Medical devices not to be adversely affected by transport or storage
- Essential Principle 6 - Benefits of medical devices to outweigh any side effects
- Part 2 Principles about design and construction
- Essential Principle 7 - Chemical, physical and biological properties
- Essential Principle 8 - Infection and microbial contamination
- Essential Principle 9 - Construction and environmental properties
- Essential Principle 10 - Medical devices with a measuring function
- Essential Principle 11 - Protection against radiation
- Essential Principle 12 - Medical devices connected to or equipped with an energy source
- Essential Principle 13 - Information to be provided with medical devices
- Essential Principle 14 - Clinical Evidence