This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant.
Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This guidance:
- helps manufacturers determine when a change made to a device is significant
- explains the concepts that manufacturers must apply when making this determination
- provides many examples to help delineate the types of changes that are significant
Manufacturers of Class II to IV medical devices who are impacted by this change are encouraged to provide feedback directly using this link.
