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As with all therapeutic goods, medical devices and IVDs are expected to be safe and perform as intended.
This guidance is currently under construction. More information and links to further guidance will be added when available.
About the Principles
The Essential Principles (the Principles) are legislative requirements relating to safety and performance characteristics of medical devices, including in vitro diagnostic (IVD) devices. The Principles are in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
Manufacturers must demonstrate that their devices meet all relevant Principles, and sponsors must either hold or be able to get this evidence from their manufacturer(s) on request.
Three key pillars
The Principles have three key pillars that the manufacturer must put in place:
- design and construct according to safety principles and risk mitigation,
- develop solutions that are state-of-the-art and best practice
- ensure that the benefit(s) of the device outweigh(s) its risks.
The Essential Principles
- Principle 1 - Use of medical devices not to compromise health and safety
Applies to all medical devices - Principle 2 - Design and construction of medical devices to conform with safety principles
Applies to all medical devices - Principle 3 - Medical devices to be suitable for intended purpose
Applies to all medical devices - Principle 4 - Long-term safety (this Principle refers to the intended lifetime of the device, however long or short that may be.)
Applies to all medical devices - Principle 5 - Medical devices are not adversely affected by transport or storage
Applies to all medical devices - Principle 6 - Benefits of medical devices to outweigh any undesirable effects
Applies to all medical devices - Principle 7 - Chemical, physical and biological properties
Applies to physical-form medical devices that are not just software, data, virtual anatomical models, or a service - Principle 8 - Infection and microbial contamination
Applies to physical-form medical devices that are not software, data, virtual anatomical models, or a service - Principle 9 - Construction and environmental properties
Applies to all medical devices - Principle 10 - Medical devices with a measuring function
Applies to medical devices (including software devices) that have a measuring function as defined in Regulation 1.4. This Principle does not apply to IVD medical devices. - Principle 11 - Protection against radiation Applies to medical devices that generate radiation as part of their intended purpose
- Principle 12 - Medical devices connected to or equipped with an energy source Applies to active medical devices
- Principle 13 - Information to be provided with medical devices Applies to all medical devices
- Principle 14 - Clinical evidence
Applies to all medical devices - Principle 15 - Principles applying to IVD medical devices
Applies to all IVD medical devices
More information
The following guides give more details on selected topics.
- Demonstrating compliance with the Essential Principles
- Active medical devices
Active medical devices are a subset of devices that use energy to operate. Software-based medical devices are a form of active medical device. This document includes guidance on the requirements that apply to these devices. - Medical device cybersecurity guidance for industry
This guidance is for manufacturers and sponsors of medical devices that include software, electronic, and other programmed/programmable components. - 3-D printing (additive manufacturing) of medical devices
This web page provides information for manufacturers to address risks and meet the Australian regulatory requirements for 3D-printed medical devices. - Clinical evidence guidelines: Medical devices
This guidance gives manufacturers of medical devices (including IVDs) information on:- what clinical evidence is
- how to generate and evaluate clinical data to produce clinical evidence.
- Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices
This document supplements existing guidance found in the Clinical evidence guidelines: Medical devices and Application audit (technical file review) of IVD medical device applications. We recommend that you review these documents together.