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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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Objective

The regulatory reform options examined by this RIS are primarily seeking to provide greater assurance that higher risk medical devices do not compromise public health and safety while at the same time:

  1. supporting the timely availability of medical devices to the Australian public
  2. minimising unnecessary regulatory burden and associated costs on the medical device industry (as these costs are passed on to users and funders of the health system)
  3. improving the ability for TGA to target emerging risks in a timely manner
  4. continuing Australia’s commitment to promoting alignment of international medical device regulation.

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