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PUBLICATION

Response to TGA Consultation – Scope of regulated software-based products

May 11, 2020

By Lee Walsh

The Australian regulations for medical device software, including Software as a Medical Device (SaMD), are undergoing reform. In April 2020 the Therapeutic Goods Administration (TGA) published a consultation paper on the scope of regulated software-based medical devices.

Platypus Technical agrees that there is a need for reform of these regulations, but has concern about some of the proposals in the paper. For the detail of our position, read our response to the consultation in full with the button below.