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Increased scrutiny of medical devices

4 July 2014

Over recent years concerns have arisen with:

  • premarket scrutiny of higher risk medical devices, particularly those which are implanted;
  • transparency of TGA decision making on medical device; and
  • use of third party assessment bodies to assess conformity of medical devices to Australian regulatory standards.

On 1 August 2013, the Regulation Impact Statement: Changes to premarket assessment requirements for medical devices was released. The Australian Government has since asked the TGA to review these proposals and develop a modified reform package, taking into account the Government's deregulation policy.

Further consultation on the modified reform package is anticipated in the second half of 2014.

Previous consultation

The decision to proceed with these reforms is based on consultations undertaken by the TGA on these issues over the past several years. There have also been a number of inquiries on medical devices and relevant reviews which are also relevant to these changes. Below are links to these various consultations and reports.

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