All medical devices supplied in Australia must meet the relevant Essential Principles for safety and performance to ensure the device is safe and performs as intended. Essential Principle 13 of Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) and Regulation 10.2 specify the requirements for information that must be provided with a medical device, including labelling and instructions for use. See Medical device labelling obligations below for details,
- Medical devices unique device identification (UDI)PageLabelling and packaging information about medical devices unique device identification (UDI).
Guidance and resources
- Medical device labelling obligationsGuidanceThis information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations.
- Off-label use of medical devices: Frequently asked questionsGuidanceAnswers to frequently asked questions about off-label use of medical devices.
More information
Labelling and instructions for use
- Medical device labelling obligations
- The Poisons Standard and medical devices
- Electronic Instructions for Use - eIFU
Patient implant cards and information leaflets
Topics