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Security guidance for medical devices issued by Therapeutic Goods Administration


19th July 2019

New guidelines for the security of medical devices and in vitro diagnostic (IVD) medical equipment has been published by Australia’s Therapeutic Goods Administration (TGA).

The guidance was revealed on 18th July, comes in one version for Guidance for consumers, health professionals, small business operators and large scale service providers and another for industry.

“Essential Principles” are also listed in the Guidance meant for the industry to provide flexibility. The manufacturers are advised to take the responsibility to determine the essential principles and demonstrate compliance with them. Security risks related to the devices should also be kept in mind to avoid any failure.

The Users Guidance is little meatier, as it addresses small and large businesses that deploy medical devices as part of the services.

Entities the TGA classes as those “responsible for implementing medical devices in critical health services” or “large-scale service providers” are advised to “develop a clear and well documented risk management strategy.”

Network security precautions, penetration testing and ensuring physical security of medical devices is recommended in the plan.
The consumers guidance includes anodyne advice such as “Follow instructions when using your device”.


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