Dec 8, 2010

Software manufacturers whose products fall under Health Canada’s medical device classification system have until February or September 2011 to comply with new requirements set forth by the regulator.

According to HC clarifications announced December 3, 2010, software developed to view medical-related images or data is to be assigned Class I classification according to Rule 12 of Canada’s Medical Device Regulations. Software involving imaging, data manipulation, measurements or identification capabilities now falls under Class II classification based on Regulations Rule 10 (1).

In terms of compliance with HC’s new guidelines, medical device software manufacturers will need to adhere to Section 9 of the Regulations. Class I software manufacturers must ensure compliance by February 1, 2011; Class II manufacturers must ensure compliance and obtain licenses by September 1, 2011.

Bottom line: The new HC requirements present a more consistent approach to medical device classification in Canada, and should present no significant operational burdens for affected software manufacturers in terms of compliance.


  • Stewart Eisenhart