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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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