Canada Finalizes Premarket Cybersecurity Requirements
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.
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A draft IMDRF guidance released this month aims to set the trend for how regulators around the world oversee cybersecurity of medical devices. According to experts, the document also foreshadows what sponsors can expect from the US FDA in areas such as developing a software bill of materials, as the agency updates its own cybersecurity guidances.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Twenty-four new guidance documents have been posted on the tracker since its last update.
Canada's pre-market evaluation process for medical devices will soon include evaluating the adequacy of a manufacturer's risk control measures to address cybersecurity concerns.