Health Canada ToC technical documentation requirements

[gabe2jadyn]

Hi! Does Health Canada have any special requirements for the ToC technical documenation requirements? Is it possible to set up our technical documentation to mimic UK requirements?

 

[DannyK]

Take a look at Health Canada Guidance document on this topic. Draft Health Canada IMDRF table of contents for medical device applications guidance - Canada.ca

 

[gabe2jadyn]

Thank you so much for this information and I do have this document. I am having a really hard time understanding what the requirements are for putting the ToC together. Do you know if there is a template available that I can follow?

 

[Emma2010]

Thank you so much for this information and I do have this document. I am having a really hard time understanding what the requirements are for putting the ToC together. Do you know if there is a template available that I can follow?

Hello gabe2jadyn,

Did you manage to solve the problem? If you did, would you be open to sharing the template?
I am facing the same issue of not being sure how to prepare a technical file for the application. We've successfully enrolled in the REP pilot, but we're not sure how to access the Regulatory Transaction (RT) Template. We emailed HC, but haven't heard back since April 15th.
Thank you for your time, and any advice you have would be really appreciated!
Best Regards,
Emma

 

[gabe2jadyn]

Good Morning: This is what I have been using for my Health Canada Technical File. I hope this helps as it is very informative on how this is supposed to be created. Assembly and Technical Guide for IMDRF Table of Contents Submission

 

[Emma2010]

Good Morning: This is what I have been using for my Health Canada Technical File. I hope this helps as it is very informative on how this is supposed to be created. Assembly and Technical Guide for IMDRF Table of Contents Submission

Thanks gabe2jadyn! That's super helpful!
BTW, are you familiar with the Regulatory Enrolment Process (REP) of HC? Do you know where we can access the current version of the Regulatory Transaction Template for medical devices?
Thanks again for your useful insight, and any comments you have are highly appreciated!
Best regard,
Emma

 

[gabe2jadyn]

Hi! I remember reading about this a while back but completely forgot about. So, thank you for the reminder. At this point I do not know where the transaction template is. I have the attached REP Guidance Document. I haven't looked at it yet but maybe there will be some information that will be helpful. If you already have this, sorry that I can't be more help at this time!

 

[Emma2010]

Hi! I remember reading about this a while back but completely forgot about. So, thank you for the reminder. At this point I do not know where the transaction template is. I have the attached REP Guidance Document. I haven't looked at it yet but maybe there will be some information that will be helpful. If you already have this, sorry that I can't be more help at this time!

Thank you gabe2jadyn for all your share. Really appreciate it!