Add new device to current license

D

danir30

Starting to get Involved
I wonder if there is a guidance to add a new device to current license. The new device has the same intend of use, however a new feature is added to the device which make it different to registered devices.
Should I apply for new license or add using a faxabck form?
 
MedicalDevicesCanada

MedicalDevicesCanada

Starting to get Involved
If these devices have the same model number (they shouldn't if their functionality and IFU changed) then technically it is the same device, because HC distinguish MDLs per device name and its model number (or model ID). In that case you do not need to do any modification to MDL. But you can't "add a new device to the existing MDL" because the device license is for one device specified by its model number (model ID).
If MDL was issued for a kit that contains number of devices, then same rule applies, these devices and their model numbers should not change.
 
MedicalDevicesCanada

MedicalDevicesCanada

Starting to get Involved
To add to the previous comment, sometimes the manufacturer doesn't want to go through the change of the MDL because they prefer to keep both models, and receive a new license for the modified device.
 
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