What happen if Health Canada refuses my approach for the medical device family during the review

Hi Folks,

Our company is in the process of applying for the MDL for our class IV medical device, and I'm grappling with the concept of "A Medical Device Family".

We're aiming to include more than 6 products under the same preferred name code (PNC) in one submission.
According to the guideline stating, "As a principle, materials, labelling, manufacturing processes, design, and performance specifications cannot be significantly different between the members of the family", therefore, when there is no significant difference, devices can be included into one family.
We will demonstrate in our submission that all 6 products share the same manufacturing process in the same facility of the same QM system, have the same general intended use and principles of operation, and with differences, but very similar in design, materials, and performance characteristics. We will also demonstrate that such differences don't affect the safety or effectiveness of the medical devices.
I'm curious about the next steps if Health Canada rejects this approach and whether there is any possibility of a refund in such a situation.

Your attention to this matter is appreciated, and any suggestions will be highly valued.
B&R
Emma

In my experience, Health Canada is pretty interactive with submissions and will likely just discuss with you if they have a concern.

Once I submitted an amendment with several different devices on the same license. During review, Health Canada determined that one of the devices should not be on the same license. They just emailed me to ask if I agreed to split the device out, and they did it themselves on their side - very little hassle for me.

Without knowing exactly the details of your situation, I would guess that they would simply ask you to amend or update your submission to reflect their changes. I think it is unlikely they would flat out reject/cancel the submission straight away without giving you an opportunity to make corrections.

I have called HC on occasion and _literally_ agreed to actions over the phone with them. A highly interactive and approachable team there.

For all your very useful comments, much appreciated!!!

You may find that Health Canada employees are not as available as they once were since many are working remotely since Covid-19.
Nonetheless you should be able to contact the person who reviewed your file and they will probably get back to you.

DannyK said:

You may find that Health Canada employees are not as available as they once were since many are working remotely since Covid-19.
Nonetheless you should be able to contact the person who reviewed your file and they will probably get back to you.

Click to expand...

Hi Danny,
Thank you for your comments and looks like you are right. We have sent the consultant email to HC for nearly 2 weeks and still haven't received any response yet.

I have this situation happen to me and all I get is a standard email that points to the Health Canada Guidance documents and web sites. My colleague used to work at Health Canada as a medical device evaluator so we have a bit of insight on how things work.