Health Canada Posts New Notice and FAQ

Health Canada has posted a revised Notice and FAQ on Software Regulated as a Class I or Class II Medical Device (you will note that Health Canada no longer uses the term "Patient Management Software"). The new definition, from the FAQ is as follows:

"Software regulated as a medical device:

(1) provides the only means and opportunity to capture or acquire data from a medical device for aiding directly in diagnosis or treatment of a patient; or

(2) replaces a diagnostic or treatment decision made by a physician.

Software that fits part (1) of this definition would be picture archiving and communication system (PACS) and other types of software that have traditionally been licensed since they are adjuncts or accessories to medical devices.

The FAQ further clarifies that software used for remote patient monitoring (e.g. monitors used at home in a homecare situation), and software that controls or is embedded into a medical device are also medical devices.

These examples are covered under part 1 of the new definition. At this time, we are not aware of any product that meets part 2 of the definition (replaces a diagnostic or treatment decision made by a physician). It is expected that part 2 may come into play in the future when expert systems that replace a physician's judgement become available and are permitted to be deployed in the health system.

ITAC Health recommends that vendors and distributors of health software contact Health Canada to determine whether or not their products meet the new definitions.