HealthCanada FAQ sheet on Software Regulated as a Medical Device

HealthCanada released a FAQ sheet answering basic questions about software regulated as a medical device. The document clarifies that software regulated as a medical device is software which retrieves data from a medical device in order to aid or replace a physician’s decision regarding the diagnosis or treatment of a patient. Software that transmits data from a medical device in a patient’s home (remote patient monitoring), and software which is an accessory to a medical device for diagnostic or therapeutic use are also included in the definition. The document also explains the distinctions between Class I and Class II medical device software.

The FAQ sheet can be found at this link: HealthCan Medical Device Software FAQ.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
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