This document, entitled, Guidance for the Interpretation of Significant Change sets out the Programme's guidance for Industry on the subject. Every Class II, III and IV medical device sold in Canada is required to be licensed under section 26 of the Regulations. An amended licence application is required if a significant change has been made to a licensed Class III or IV medical device. This amended licence must be issued prior to the modified device being offered for sale in Canada. This guideline is intended to aid manufacturers in determining when a significant change has been made to a medical device.
Medical devices undergo almost constant evolution, in response to many factors.
Most changes are non-significant and will not trigger the need for an amended licence application.