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Canada Finalizes Premarket Cybersecurity Requirements

 
• By Vibha Sharma

The Canadian regulator says that medical device manufacturers must demonstrate in their premarket license or license amendment applications that adequate provisions are in place to monitor, prevent and respond to post‐market cybersecurity events.

Digital crime by an anonymous hacker - Image
Canada says cybersecurity threat is real enough to warrant precautions

Health Canada has issued new guidance on premarket requirements for medical device cybersecurity.

The guidance, which comes into effect immediately, requires manufacturers of devices that contain software to integrate safeguards, such as passwords, to protect against unauthorized tampering of their products.

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