Canada Allows E-Labeling of Certain Medical Devices

Canada recently published a clarification of device labeling. The new approach applies only to devices not sold to the general public.

The manufacturer may provide electronic labeling on a Compact Disc (CD) or Digital Video Disc (DVD), that accompanies the device at the time of sale and/or delivery. The CD or DVD must be packaged with or accompany the device in a manner that alerts the user to its purpose. The information provided on the CD or DVD should be easily navigable.

In addition, for Class IV devices and in vitro diagnostic devices (IVDD) that are not near patient IVDDs may provide the labeling information on the internet. The devices must include the internet address and be displayed to alert the user.

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