Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device
Information
Type
Miscellaneous
Regulated products
Medical Devices
Published
February 7, 2024
Last updated
February 7, 2024
Description
Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device.
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
Tags
Organization
Country / Region
Canada
License
Open Government License 2.0 (Canada)