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Medical devices labelling and information
Labelling and other information provided with medical devices.
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.