Posted by Michael Wonder on 16 Aug 2020
Submissions received: scope of regulated software based medical devices
14 August 2020 - A total of 48 submissions were received in response to the Scope of Regulated Software based products consultation paper.
The majority of respondents were supportive of the regulatory scheme and the concept of carve outs to reduce regulatory burden.
A number of submissions made suggestions on how the regulatory scheme could be enhanced or fine-tuned, noting that further clarification was required specifically on definitions and a shared understanding of risk and how it may inform a carve-out. In addition, many respondents whilst supportive of a carve-out also suggested that the TGA continue to play an ongoing monitoring or "stewardship" role of those devices subject to the carve-out.
