Reforms to software-based medical devices take effect this week
Summary
These reforms arise following public consultation in early 2019 which identified the need to better address the classification of SaMDs in line with the European Medical Device Regulation and international best practice. These changes narrow the category of devices exempt from registration onto the Australian Register of Therapeutic Goods (“ARTG”) and introduce new annual reporting requirements to the TGA. This means documents demonstrating the safety, quality and performance of a device will need to be prepared and provided to the TGA upfront. For existing devices, transitional arrangements will apply to ensure sponsors can continue to supply their products while new applications are submitted to the TGA for inclusion into the ARTG under the new classification. Due to the COVID-19 pandemic, the implementation of a number of medical device reforms have been delayed to commence on 25 November 2021.