Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello everyone, 

I'm trying to clarify the potential regulatory pathways for Health Canada to license standalone software products.  Currently, one product we have is a standalone software. There are two questions/issues: 

1) The standalone software's first version (e.g. 1.0) was licensed as a device family with its download product identifier.  (1.0+ABCD) where 1.0 is the identifier for the software version; ABCD is a placeholder, but it's just the product identifier traced within SAP. The software version is not traced other than through ABCD.   I'm not exactly sure what makes 1.0 + ABCD a device family. I think it might be because the software cannot be traced if ABCD is not included.   Now version 1.X comes along where there is a minor version update.  One way  to add this is through a Class II amendment to the device family.  But Health Canada has come back to question why 1.X and 1.0 are in the same device family.  Is there any other way to add the new version given these circumstances? One alternative is to start a new license. This then requires that we start a new licence for each version change. Can somebody offer some insight?  

2) A more general question: for standalone software where there are frequent version changes (major and minor), what is the best way to license these products? Do we start with a "single device" licence type and then do amendment applications for future versions and explain how they all fit into a device family?   The reason we go the device family route is that we have different version numbers in distribution. 


I'd appreciate any help.  Thank you so much. 

This message was posted by a user wishing to remain anonymous

Hello,

I'm just registering a class II standalone software product and had some similar feedback on device identification, ragrding traceability and similar devices.

I also listed as product family, had no comments on that. They have asked that we change the device identifier to be say 1.0 (Major.Minor) and include a screenshot in the submission showing the actual full version number). They said if we do a bug fix, then this can be done via a license amendment (free for class II I think).

Hope this helps a bit.

Original Message:
Sent: 22-Aug-2021 19:55
From: Anonymous Member
Subject: Standalone Software - Health Canada Licensing

This message was posted by a user wishing to remain anonymous

Hello everyone,

I'm trying to clarify the potential regulatory pathways for Health Canada to license standalone software products.  Currently, one product we have is a standalone software. There are two questions/issues:

1) The standalone software's first version (e.g. 1.0) was licensed as a device family with its download product identifier.  (1.0+ABCD) where 1.0 is the identifier for the software version; ABCD is a placeholder, but it's just the product identifier traced within SAP. The software version is not traced other than through ABCD.   I'm not exactly sure what makes 1.0 + ABCD a device family. I think it might be because the software cannot be traced if ABCD is not included.   Now version 1.X comes along where there is a minor version update.  One way  to add this is through a Class II amendment to the device family.  But Health Canada has come back to question why 1.X and 1.0 are in the same device family.  Is there any other way to add the new version given these circumstances? One alternative is to start a new license. This then requires that we start a new licence for each version change. Can somebody offer some insight?

2) A more general question: for standalone software where there are frequent version changes (major and minor), what is the best way to license these products? Do we start with a "single device" licence type and then do amendment applications for future versions and explain how they all fit into a device family?   The reason we go the device family route is that we have different version numbers in distribution.


I'd appreciate any help.  Thank you so much.

Health Canada is very particular about the Licence type when processing applications for Medical Device Licencing.  However, the licence type categorization is usually open for some negotiation as long as the manufacturer is basing its proposed categorization in good faith regarding Health Canada's categories.  On that note, a Medical Device Family Licence is fundamentally intended to cover a family of devices that are, for practical intents and purposes, identical in design and function except for being different shapes, colours, sizes, etc.  So in those terms, if a software change from 1.0 to 1.X only represents such changes, then that is a good candidate to lobby it as a change within a family.  But my experience, and I think that of Health Canada, is that changing from 1.0 to 1.X often includes software functional or interfacial changes, in which case Health Canada would typically expect to see those licenced as separate single medical device licences.

------------------------------
Kevin Randall, ASQ CQA, RAC (Canada, U.S., Europe)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 22-Aug-2021 19:55
From: Anonymous Member
Subject: Standalone Software - Health Canada Licensing

This message was posted by a user wishing to remain anonymous

Hello everyone,

I'm trying to clarify the potential regulatory pathways for Health Canada to license standalone software products.  Currently, one product we have is a standalone software. There are two questions/issues:

1) The standalone software's first version (e.g. 1.0) was licensed as a device family with its download product identifier.  (1.0+ABCD) where 1.0 is the identifier for the software version; ABCD is a placeholder, but it's just the product identifier traced within SAP. The software version is not traced other than through ABCD.   I'm not exactly sure what makes 1.0 + ABCD a device family. I think it might be because the software cannot be traced if ABCD is not included.   Now version 1.X comes along where there is a minor version update.  One way  to add this is through a Class II amendment to the device family.  But Health Canada has come back to question why 1.X and 1.0 are in the same device family.  Is there any other way to add the new version given these circumstances? One alternative is to start a new license. This then requires that we start a new licence for each version change. Can somebody offer some insight?

2) A more general question: for standalone software where there are frequent version changes (major and minor), what is the best way to license these products? Do we start with a "single device" licence type and then do amendment applications for future versions and explain how they all fit into a device family?   The reason we go the device family route is that we have different version numbers in distribution.


I'd appreciate any help.  Thank you so much.