Generally speaking, yes, it is required to list all device configurations.
Specifically, the "identifier" typically corresponds to the catalog number / marketing part number. My experience is that manufactures generally have unique catalog numbers / marketing part numbers for different product configurations / models, etc.
It is important to know Health Canada's official definition of "identifier". Here it is:
A unique series of letters or numbers or any combination of these or a bar code that is assigned to a medical device by the manufacturer and that identifies it and distinguishes it from similar devices.
Moreover, remember that the identifier must appear on the device label. Conversely, if you identify a catalog number / marketing part number on the label already, then Health Canada would generally recognize that to be the identifier.
If such identifiers aren't specifically itemized on the licence application (which leads to their itemization on the resulting device licence), then the device(s) corresponding to those identifiers won't be considered to be licenced.
------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------
Original Message:
Sent: 01-Aug-2022 17:48
From: Anonymous Member
Subject: Health Canada License application - Item 13 Identifier of Device
This message was posted by a user wishing to remain anonymous
Hi,
I have a question on device identifiers. For HC medical device license application, there is a section on "IDENTIFIER OF DEVICE" (Only devices, components, parts and accessories listed on the application will be considered for licensing.). Is there a need to list all device configurations? The device in question has several combinations such as, device with different accessories and one as standalone system. Our team has conflicting approaches to listing these on HC website.
Is it appropriate to list only the main device and not list other configurations with accessories and PC?
In case if all configurations are not listed on the license will there be any export issues?
Please share your experiences.
Thanks!