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.
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GuidanceGuidance on how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.
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GuidanceGuidance on the use of a medical device in a way that is not included in the intended purpose in the Australian Register of Therapeutic Goods (ARTG), and rules for advertising off-label uses.
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TopicA collection of information about the implementation of medical devices Unique Device Identification (UDI).
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GuidanceGuidance for the requirements applicable to medical devices containing poisons.
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GuidanceGuidance for manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format.
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GuidanceGuidance on how to provide the required patient information materials with all implantable and active implantable medical devices.