Regulatory Open Forum

Hello Community!

I recently submitted an ITA to Health Canada for a non-IVDD medical device using their ITA guidance document, which I downloaded directly from their website. I used the email address mentioned numerous times throughout that guidance. Immediately after submitting, I got a notification saying the email address was invalid and the message didn't go through. 

Luckily a colleague had successfully submitted an ITA recently and I was able to compare the email address in that submission to the one I used - they were different!

The submission email in Health Canada's own guidance document is incorrect! 

Does anyone know of a way to provide feedback to Health Canada about problems like these? As a Canadian, I am slightly embarrassed that our health regulator cannot meet the same standards for document control that it places on the manufacturers it regulates.

Thanks in advance for any help you can provide!

Rebecca,

Well it is not surprising the email address is not up to date - what happens when "older" guidance documents are created and not maintained.  I would reach out to health Canada directly as they are well responsive and usually can get you to the right person.  In my experience with this, they usually say, yes we know though a new version is coming out soon (TM).

Hello Community!

I recently submitted an ITA to Health Canada for a non-IVDD medical device using their ITA guidance document, which I downloaded directly from their website. I used the email address mentioned numerous times throughout that guidance. Immediately after submitting, I got a notification saying the email address was invalid and the message didn't go through. 

Luckily a colleague had successfully submitted an ITA recently and I was able to compare the email address in that submission to the one I used - they were different!

The submission email in Health Canada's own guidance document is incorrect! 

Does anyone know of a way to provide feedback to Health Canada about problems like these? As a Canadian, I am slightly embarrassed that our health regulator cannot meet the same standards for document control that it places on the manufacturers it regulates.

Thanks in advance for any help you can provide!

Hello Community!

I recently submitted an ITA to Health Canada for a non-IVDD medical device using their ITA guidance document, which I downloaded directly from their website. I used the email address mentioned numerous times throughout that guidance. Immediately after submitting, I got a notification saying the email address was invalid and the message didn't go through. 

Luckily a colleague had successfully submitted an ITA recently and I was able to compare the email address in that submission to the one I used - they were different!

The submission email in Health Canada's own guidance document is incorrect! 

Does anyone know of a way to provide feedback to Health Canada about problems like these? As a Canadian, I am slightly embarrassed that our health regulator cannot meet the same standards for document control that it places on the manufacturers it regulates.

Thanks in advance for any help you can provide!

Hi Becki

Yes, very frustrating!  I understand it takes time for revisions to guidance documents to be scheduled, prioritised, written, reviewed, and published, but difficulties like this one are avoidable. Where addresses are not expected to be stable, it might be better to point to a stable web page where the current address can be found - then the document wouldn't have to be revised just for that. And when addresses change, the technology exists to automate forwarding, or to reply with an indication of the new address that should be used.

Hoping this one is up-to-date, here's a place for making suggestions about the address:

https://www.canada.ca/en/health-canada/corporate/contact-us/technical-difficulties.html

For suggestions about the guidance document needing revision, perhaps one of these:

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/medical-devices-directorate.html

https://www.canada.ca/en/health-canada/corporate/contact-us.html

Original Message:
Sent: 10-Nov-2023 12:23
From: Rebecca Hiebert
Subject: Health Canada Guidance Document Feedback

Hello Community!

I recently submitted an ITA to Health Canada for a non-IVDD medical device using their ITA guidance document, which I downloaded directly from their website. I used the email address mentioned numerous times throughout that guidance. Immediately after submitting, I got a notification saying the email address was invalid and the message didn't go through. 

Luckily a colleague had successfully submitted an ITA recently and I was able to compare the email address in that submission to the one I used - they were different!

The submission email in Health Canada's own guidance document is incorrect! 

Does anyone know of a way to provide feedback to Health Canada about problems like these? As a Canadian, I am slightly embarrassed that our health regulator cannot meet the same standards for document control that it places on the manufacturers it regulates.

Thanks in advance for any help you can provide!