Australia: Medical device cyber security guidance for industry

22-07-2019

Australia: Medical device cyber security guidance for industry

(Source: TGA 2019-07-22)

The premarket requirements on medical device cybersecurity from Australia’s Therapeutic Goods Administration (TGA) came into effect on Thursday, with new details that further underscore the agency’s push for the total product lifecycle (TPLC) approach and international harmonization.

This guidance is for manufacturers and sponsors of medical devices that include software or electronic components.

The guidance is intended for:

● manufacturers that develop software for use in or as standalone medical devices, such as in Software as a Medical Device (SaMD); this includes devices that incorporate artificial intelligence in their design

● manufacturers of medical devices (including in-vitro diagnostic medical devices) where devices include components that may be vulnerable to cyber-based threats

● medical device sponsors who are responsible for the supply of medical devices in Australia, to ensure that safety and quality is demonstrated and compliance with the Essential Principles is maintained.

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