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Can someone provide some examples of when Health Canada would be notified via a license amendment for a Class II device in regards to 34(f) of the regulation:
in the case of a Class II medical device other than a decorative contact lens, a change in the medical conditions, purposes or uses for which the device is manufactured, sold or represented.
Does this only mean a change to the intended use and/or indications for use? Or would notification be required if a warning was added to the label? addition of expiration date to the label? I am aware there is guidance surrounding significant changes to Class III and IV devices but I haven't been able to locate anything that clarifies requirements for Class II devices.