Summary
April 2019
Software is regulated by the TGA under the existing medical device framework; however advances in technology, including the emergence of ‘apps’ has resulted in the TGA consulting on proposed regulatory reforms for medical device software including software that functions as a medical device in its own right (SaMD).
The RACGP response to the consultation:
- supports the regulation of software used as medical devices
- does not support the regulation of general practice clinical information systems by the TGA
- identifies the RACGP as being well placed to provide regulation for clinical information systems and other tools used in general practice and these systems should not be regulated by the TGA