Upcoming changes in Medical Devices Regulation in Australia

Currently, the Australian Therapeutic Goods Administration (TGA) recognises CE marking, making easier the approval process for CE-marked devices in Australia. Classification is likely to be the same and CE Technical Files or Design Dossier are accepted for submission to TGA.

In October 2014, the government announced the creation of an independent Expert Panel whose purpose was to assess the current regulatory framework and identify opportunities for improvement of the medicines and medical devices regulation.

This panel issued 58 recommendations for reform, which were almost all accepted by the Australian Government in September 2016.

One of the recommendations, number 20, states that, wherever possible, the Australian regulation for medical devices must be aligned with the European Union framework in term of classification, Essential Requirements and risk-based approach.

As, the changes implemented by the Medical Device Regulation published in May 2017 (Regulation EU 2017-745)  were not assessed during the initial consultation process, the TGA is now seeking opinion from stakeholders on issues and consequences of the implementation of two measures included in the new EU Regulation:

  • The reclassification of all implantable surgical mesh from class IIb to class III,
  • The introduction of patient implant cards for all implantable medical devices

The public consultation ends on 25th August.

Other alignment measures are already planned, with consultation expected during 2018.

If you are interested in giving your opinion, you can access the consultation of the TGA website here.