As of September 1, 2011, Manufacturers, importers and distributors of medical device software and facilities that purchase patient management software must comply with Health Canada Medical Device Regulations, including the requirement for a valid ISO 13485 (CMDCAS) Quaity System Certification. Any changes made to the device must be consistent with paragraph 34 of Health Canada Medical Device Regulations.
It is therefore important for your organization to ensure that your Patient Management Software is licensed for sale or use within Canada.