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Premarket Scrutiny of Medical Devices – Regulation Impact Statement – Department of Health and Ageing

On 1 August 2013, the Department of Health and Ageing announced changes to premarket assessment requirements for medical devices. A medical device must be included in the Australian Register of Therapeutic Goods (ARTG) prior to supply in Australia. An application to include a medical device in the ARTG may only be made once a conformity assessment certificate is issued by a conformity assessment body. Concerns have been raised regarding the use of third party conformity assessment bodies, the need for an increased level of premarket scrutiny of higher risk medical devices and the transparency of the Therapeutic Goods Administration’s (TGA) decision making processes. The proposal addresses these concerns by:

  1. increasing the scrutiny of conformity assessment evidence as part of mandatory application audits prior to ARTG inclusion. (This will be done by increasing the number of products targeted for mandatory audits and introducing a new Level 3 audit to assess additional evidence of conformity for certain devices);
  2. publishing medical device regulatory decisions; and
  3. removing the requirement for TGA conformity assessment for Australian manufacturers of all medical devices except Class 4 in vitro diagnostic devices (IVDs).

Proposal one would place additional costs on industry in complying with the new requirements such as: obtaining and providing additional information due to the increase in the number of devices subject to a mandatory audit; providing additional information which is required for a Level 3 audit; and potentially longer processing times for those applications subject to additional audit requirements. However, proposal three would reduce costs and allow faster market entry for Australian manufacturers. A Regulation Impact Statement was prepared by the Department of Health and Ageing and assessed as adequate by the Office of Best Practice Regulation, under the June 2010 Australian Government best practice regulation requirements.