Australia – Update on reclassification of a number of medical devices

The TGA thanks respondents who provided submissions in response to the consultations published in early 2019, relating to the proposed reclassification of a number of categories of medical devices.

The consultations related to the implementation of the Australian Government Response to the Expert Panel Review of Medicines and Medical Devices Regulation (MMDR), in particular Recommendation 20 that prescribes that the regulation of medical devices in Australia, wherever possible, should be aligned with the European Union (EU) medical devices framework including in respect of the classification of medical devices…