Medical devices reforms

15 October 2014

Pre-market assessment of medical devices reforms

The TGA is implementing a series of medical device regulatory reforms increasing the rigour of pre-market assessment of higher risk medical devices, to assure the quality, safety and performance of these devices.

Further information on key reforms is available from:

IVD medical devices reforms

Extension to the timeframe for the transition to the IVD regulatory framework

The current regulatory framework for in vitro diagnostic medical devices (IVDs) was introduced in 2010 via amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990. The provisions included a 4-year transition period for IVDs supplied in Australia prior to 1 July 2010, with all such IVDs required to comply with the new requirements by 1 July 2014.

Due to difficulties encountered during the transition period, the TGA proposed an extension to the timeframe. An extension has now been made through amendments to those regulations. The new deadlines to demonstrate compliance with the IVD regulatory framework are summarised in the table below. They will come into effect immediately before 1 July 2014.

The new transitional provisions do not apply to any product that was supplied prior to 1 July 2010 and since this date, has been the subject of an application for inclusion in the Australian Register of Therapeutic Goods (ARTG) under Chapter 4 of the Therapeutic Goods Act 1989 that was rejected. These products cannot be legally supplied after 30 June 2014 unless they are included in the ARTG.

There is no annual charge for IVDs included in the ARTG under Chapter 4 of the Act for the 2013-2014 financial year. This exemption will continue to the end of the 2016-2017 financial year when the transition period ends.

Deadline Requirement for transitioning IVDs
31 August 2014

Submission of an effective application1 for TGA conformity assessment certificates for:

  • Commercial manufacturers of Class 4 IVDs; and
  • Australian commercial manufacturers of Class 2 and Class 3 IVDs

For Class 4 IVDs an effective application needs to be made for a Quality Management System Certificate (either Full Quality Assurance Procedures or Production Quality Assurance Procedures) and a Design Examination or Type Examination Certificate for each individual Class 4 IVD.

30 June 2015

Submission of an effective application1 for inclusion in the ARTG for all commercial IVDs.

Provision has been made for supply of IVDs beyond 30 June 2015 if the TGA has not issued a conformity assessment certificate (in relation to an application received prior to 1 September 2014) by this date.

30 June 2016

Submission of an effective application1 for TGA conformity assessment certificates for laboratories that manufacturer Class 4 in-house IVDs.

For Class 4 in-house IVDs an effective application needs to be made for a Quality Management System Certificate (either Full Quality Assurance Procedures or Production Quality Assurance Procedures) and a Design Examination or Type Examination Certificate for each individual Class 4 in-house IVD.

30 June 2017

Submission of an effective application1 for inclusion in the ARTG for Class 4 in-house IVDs and notification of Class 1-3 in-house IVDs.

Provision has been made for supply of Class 4 in-house IVDs beyond 30 June 2017 if the TGA has not issued a conformity assessment certificate (in relation to an application received prior to 1 July 2016) by this date.

  1. An application is considered to be effective once the prescribed application fee has been paid.

If you require further information on the timeframe extension please email, devicereforms@tga.gov.au.