Hi Elizabeth! Health Canada's site, while not always intuitive, does have fairly detailed guidance on the preparation and expected content of submissions if you are willing to dig a little. I tend to use a Google search to find what I need rather than trying to search their site. Their most used pages will usually pop up. I used "Health Canada medical device submission format" to find the links below.
Did you find this guidance in your search?
HC Draft IMDRF GuidanceThey have a 2021 guidance on new licence submission that also references the guidance above. I had not read through it before today, but I saved it in my resource files.
Check it out.The folder structure can be downloaded by device class. I haven't done it in awhile, but the last time I downloaded, there were two versions where one was just the empty file structure and the other contained individual guidance for the contents of each folder/subfolder.
Table 1 in that guidance is not named exactly what it is, but it cover "minor" change content requirements. R items are required. CR items are conditionally required. NR items are not required. O items are optional. Essentially, you either populate the folder or you delete it.
It also helps to just take the time to click through links embedded in this guidance to see what else they have provided.
I hope this helps!
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Robin Haden RAC
Sr. Regulatory Affairs Specialist
New Hill NC
United States
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Original Message:
Sent: 09-Nov-2021 16:22
From: Elizabeth Goldstein
Subject: Health Canada - Amendment requirements for medical devices
Hello,
I am seeking some guidance on amendment applications for Health Canada, in particular for class III and class IV medical devices.
I have located the following resources - the regulations, guidance document and amendment form:
- https://laws-lois.justice.gc.ca/eng/regulations/sor-98-282/
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-guidance-supporting-evidence-provided-new-amended-licence-applications-class-class-medical-devices-including-vitro-diagnostic.html
- https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/forms.html
I have never had the best luck navigating the Health Canada website - for whatever reason I do not find it to be particularly intuitive, and it has been some time since I have had to work on any amendment applications so I am struggling to verify what exactly is required (aside from the form). I did some research online and found an article on regdesk:
It is important to mention that the scope of the present Health Canada guidance covers only the approach to be applied by a medical device manufacturer when determining whether the changes made to a medical device qualify as "significant." All aspects related to the submission of an application for an amended medical device license, including its structure, content, as well as regulatory procedures associated thereto fall outside of its scope. The document also provides recommendations on assessing the impact of several changes to a medical device in terms of the impact caused by each change separately as well as their collective impact. Irrespective of the nature of changes made, a side-by-side comparison to a medical device already placed on the market could be applied in order to assess the impact of such changes and their significance.
(https://www.regdesk.co/health-canada-notice-on-interpretation-of-significant-changes/)
Aside from the form, I am not sure what Health Canada is expecting to see in an initial amendment submission for high risk medical devices? If anybody has recent experiences that they can share, I would greatly appreciate it!
Thank you!
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Elizabeth Goldstein RAC
United States
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