Lexology January 18, 2019
Regulating software as a medical device
With huge technological advances being made in the delivery of health products and services, it is crucial to keep an eye on any regulatory movement. This is particularly important in the case of software, which is both incorporated into medical devices and may in and of itself hold the status of medical device.
The Therapeutic Goods Administration (TGA) has recently published guidance on the regulation of software as a medical device (SaMD) in Australia.
The regulation of SaMD products in Australia is based on risk. The level of oversight by the TGA varies according to the risk the TGA assesses a product poses to patients and healthcare professionals.
Recently, concerns have been raised that...
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