Standards, guidelines & publications (medical devices & IVDs)

All medical devices marketed in Australia must meet the requirements which are set out in Chapter 4 of the Therapeutic Goods Act 1989, and in the Therapeutic Goods (Medical Devices) Regulations 2002.

Related guidance and standards

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  • Electronic Instructions for Use - eIFU
    Guidance for manufacturers of medical devices who may be considering supplying the instructions for use of their device in an electronic or online format

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  • In vitro fertilisation (IVF) solutions
    Summarises requirements for IVF solutions to demonstrate compliance with the Essential Principles for safety and performance of medical devices, or the Australian Medical Device Requirements (DR4, for devices containing material of human origin)

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