Health Canada - Medical Device/Software Regulations and Licensing

Abstract

Health Canada has clarified that "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." In addition, Health Canada has clarified what medical software is regulated as a Class I and Class II Medical Device. What is your hospital doing about complying with the new requirement? Do you need to worry about this new requirement? What about homemade software? In this session, we will address these concerns and provide more clarifications directly from the source. This is a must session if your hospital uses software in medical devices.