The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
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 - external site (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.