TGA Publishes Guidance on Medical Device Cyber Security

Australia’s Therapeutic Goods Administration (TGA) has released guidance containing cyber security considerations for manufacturers and sponsors of devices that include software or electronic components.

The guidance outlines pre- and post-market regulatory requirements, technical cyber security considerations, vulnerabilities and exploits, risk assessments and other items.

TGA said that manufacturers are responsible for assessing and managing the cyber security risks of their devices before they reach the market. After a device becomes available for sale, manufacturers and sponsors must continually assess risks and take action when necessary.