Increased scrutiny of medical devices
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.
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.
- Consultation: Regulation Impact Statement (RIS) exposure draft: Changes to premarket assessment requirements for medical devices
- Consultation: Changes to premarket assessment requirements for medical devices: Proposal paper
January to March 2013
- TGA Blueprint Implementation Plan: 16 July 2012
- Senate Standing Committee on Community Affairs Inquiry: 31 May 2012
The role of the Government and the Therapeutic Goods Administration (TGA) regarding medical devices, particularly Poly Implant Prothese (PIP) breast implants
- Senate Standing Committee on Community Affairs Inquiry: 22 November 2011
The regulatory standards for the approval of medical devices in Australia
- TGA Blueprint: 8 December 2011
- TGA Transparency Review: 20 July 2011
- Consultation: Reforms in the medical devices regulatory framework
October to December 2010
- Review of Health Technology Assessment in Australia: December 2009
- Consultation: Use of third party conformity assessment bodies for medical devices supplied in Australia
December 2008 to March 2009