23 June 2023

The Australian TGA is seeking feedback on the risk classification of medical devices

The Australian Therapeutic Goods Administration (TGA) has opened a consultation on 16th of June 2023 on the risk classification of medical devices containing certain animal, microbial or recombinant materials.


This follows the Australian Government, which is currently undertaking a wide-ranging reform program for the regulation of medical devices in Australia. The current Australian Medical Devices Regulation was adopted in 2002. It requires medical devices containing tissues, cells or substances of various origins to be classified as Class III medical devices, i.e. high risk, under rule 5.5, Schedule 2 – Classification rules for medical devices other than IVD medical devices.


The risk classification of medical devices takes into account a number of factors, for example

  • potential harm,
  • terms of use and
  • where in the human body the device is used.


After over 20 years, the authority is now examining whether the risks of the materials have changed over the course of time in order to reclassify the products. In order to be able to adapt the risk assessment to today’s state of affairs, the TGA is asking for feedback regarding the risk of specific materials (animal, microbial or recombinant origin), microbial and recombinant materials in general and the use of evidence from comparable foreign medical device regulatory authorities. In addition, the administration is considering closer coordination with the European Union.While the Australian regulations refer to medical devices containing microbial or recombinant tissues, cells or other substances, the EU only refers to products of animal origin. Other issues raised in the consultation include the recognition of evidence from comparable foreign regulatory bodies.


The TGA is accepting feedback on possible changes to the Australian medical device framework in this regard until 28th of July 2023.