Draft guidance on how to interpret ‘significant change’ of a medical device: Overview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