Australia – Medical device labelling obligations

This information explains the labelling requirements for medical devices to help manufacturers and sponsors meet their obligations. Labelling refers to labels and other information that must be provided with a medical device.

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) outlines the requirements for information that must be provided with a medical device, including labelling and instructions for use…