Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello, 

I have a question about Health Canada Class III licensing. If there are several software-driven hardware devices in a product family but only have one operation manual that covers all the devices , is it possible to have one IFU that covers all different licenses?  We were recommended to separately license these instruments even though they are similar with non-significant design changes.  The original route was to license them as a device family, but this route was rejected by Health Canada. The only major difference is the use of a different PCB board design and other changes including a new door design to open the back of the instrument.  No change to the risk profile..   Does anyone have experience with this type of situation?  Why are these two considered significantly different by Health Canada that they need separate licenses? This is where the one IFU comes in. How will this affect marketing of the devices if there is only IFU that covers multiple licenses? 

Thank you!  Any input would be appreciated!

Hello,

I would recommend reaching out to your Notified Body Scheme Manager for advice.  A few years back, I had luck reaching out to Health Canada directly with questions, I'm not sure if that is still an option, but worth a try.


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Gretchen Upton
RAC, CQA, CCRP
QA/RA consultant
San Antonio, TX
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Original Message:
Sent: 24-Aug-2021 22:23
From: Anonymous Member
Subject: Health Canada Licensing for Class III - One IFU for multiple licences

This message was posted by a user wishing to remain anonymous

Hello,

I have a question about Health Canada Class III licensing. If there are several software-driven hardware devices in a product family but only have one operation manual that covers all the devices , is it possible to have one IFU that covers all different licenses?  We were recommended to separately license these instruments even though they are similar with non-significant design changes.  The original route was to license them as a device family, but this route was rejected by Health Canada. The only major difference is the use of a different PCB board design and other changes including a new door design to open the back of the instrument.  No change to the risk profile..   Does anyone have experience with this type of situation?  Why are these two considered significantly different by Health Canada that they need separate licenses? This is where the one IFU comes in. How will this affect marketing of the devices if there is only IFU that covers multiple licenses?

Thank you!  Any input would be appreciated!

Hello,

I have observed products on multiple licenses being covered by a single IFU.  The license types (e.g.  single device, device family etc.) and structure (e.g. multiple licenses as opposed to a single license) are based on the specified license type definitions and Health Canada and/or manufacturer preference. These aspects do not necessarily impact the IFU.  

I agree with Gretchen that it might be helpful to try to reach out to Health Canada directly to better understand their position.

------------------------------
Camille Thorpe, RAC
Toronto, ON
Canada
------------------------------

Original Message:
Sent: 24-Aug-2021 22:23
From: Anonymous Member
Subject: Health Canada Licensing for Class III - One IFU for multiple licences

This message was posted by a user wishing to remain anonymous

Hello,

I have a question about Health Canada Class III licensing. If there are several software-driven hardware devices in a product family but only have one operation manual that covers all the devices , is it possible to have one IFU that covers all different licenses?  We were recommended to separately license these instruments even though they are similar with non-significant design changes.  The original route was to license them as a device family, but this route was rejected by Health Canada. The only major difference is the use of a different PCB board design and other changes including a new door design to open the back of the instrument.  No change to the risk profile..   Does anyone have experience with this type of situation?  Why are these two considered significantly different by Health Canada that they need separate licenses? This is where the one IFU comes in. How will this affect marketing of the devices if there is only IFU that covers multiple licenses?

Thank you!  Any input would be appreciated!