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.