In December 2010 Health Canada added some new information on how it regulates software that is a medical device. The Notice says, “Software that is intended or represented for use in the diagnosis or treatment of an abnormal physical state of a patient meets the definition of a medical device under the Food and Drugs Act and must therefore comply with the requirements of the Medical Devices Regulations.”
The two documents, posted on Dec. 12, 2010, are:
Software Regulated as a Medical Device – Frequently Asked Questions
Notice – Software Regulated as a Class I or Class II Medical Device
You can read the documents on the Health Canada website
http://www.hc-sc.gc.ca/dhp-mps/md-im/update-miseajour/index-eng.php