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Understanding regulatory basics on medical devices for health practitioners

This guidance helps Australian health practitioners, that manufacture, supply, and use medical devices, to understand whether you are regulated by us, and how to comply. 

Published

Purpose

This guidance is to help Australian health practitioners identify:

  • how regulatory concepts might apply to you, and
  • the specific features of a medical device and how circumstances of your own practice/business may impact the way it is regulated in Australia.

Legislation

Guidance

This Guidance is presented as downloadable files because of its length. 

Downloads

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Page history

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Original publication. 

Original publication.