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Australia TGA: Regulatory Guidelines for Medical Devices (ARGMD)

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information on the import into, export from and supply of medical devices within Australia and explains the legislative requirements that govern medical devices.

The Essential Principles (the Principles) are legislative requirements relating to safety and performance characteristics of medical devices, including in vitro diagnostic (IVD) devices.

The Principles have three key pillars that the manufacturer must put in place:

  • design and construct according to safety principles and risk mitigation,

  • develop solutions that are state-of-the-art and best practice

  • ensure that the benefit(s) of the device outweigh(s) its risks.

Manufacturers must demonstrate that their devices meet all relevant Principles, and sponsors must either hold or be able to get this evidence from their manufacturer(s) on request. This guidance is currently under construction.

Click this LINK to know more about Essential Principles guidance and the Regulatory Guidelines for Medical Devices (ARGMD).


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